Phase 2 Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Chronic Prosthetic Joint Infection of the Knee or Hip Without Exchange Arthroplasty

TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens. This Phase 2 study is designed to assess efficacy and safety of TRL1068 in combination with a DAIR (debridement, antibiotics, and implant retention) procedure for chronic prosthetic joint infections of the knee and hip, specifically, eliminating the need for the standard of care 2-stage exchange surgery, so that the original prosthesis can be retained.

Start Date01 Jan 2025

Sponsor / Collaborator

Trellis Bioscience, Inc.

NCT05355207 / Not yet recruitingPhase 1

Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TRL1068 in Subjects With Acute Exacerbation of Chronic Rhinosinusitis

TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens. This initial study is to assess overall safety and pharmacokinetics (PK) of TRL1068. The goal of the development program is to demonstrate effectiveness of TRL1068 in difficult to treat bacterial infections such as in CRS.

Start Date01 Jan 2024

Sponsor / Collaborator

Trellis Bioscience, Inc.

NCT04763759 / CompletedPhase 1

A Phase 1, Blinded, Single Ascending Dose Study to Evaluate Safety, Pharmacokinetics, and Activity of TRL1068 in Subjects With Prosthetic Joint Infection of the Knee or Hip, Undergoing Primary Two Stage Exchange Arthroplasty

TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.

Start Date08 Feb 2021

Sponsor / Collaborator

Trellis Bioscience, Inc.

[+9]

100 Clinical Results associated with Calpurbatug

100 Translational Medicine associated with Calpurbatug

100 Patents (Medical) associated with Calpurbatug

Literatures (Medical) associated with Calpurbatug

07 Aug 2024·Antimicrobial Agents and Chemotherapy

Phase 1 study of the pharmacokinetics and clinical proof-of-concept activity of a biofilm-disrupting human monoclonal antibody in patients with chronic prosthetic joint infection of the knee or hip

Article

Author: Incavo, Stephen ; Ryser, Stefan ; Adams, John S ; Leighton, Anton ; Kisch-Hancock, Adriane ; Bernthal, Nicholas M ; Conway, Janet ; Delanois, Ronald E ; Mont, Michael A ; Stavrakis, Alexandra ; Salvagno, Ralph ; McPherson, Edward ; Oakes, Daniel ; Kauvar, Lawrence M ; Tenorio, Edgar ; Stolarski, Edward

ABSTRACT We report the results of a first-in-human phase 1 clinical study to evaluate TRL1068, a native human monoclonal antibody that disrupts bacterial biofilms with broad-spectrum activity against both Gram-positive and Gram-negative species. The study population consisted of patients with chronic periprosthetic joint infections (PJIs) of the knee or hip, including both monomicrobial and polymicrobial infections, that are highly resistant to antibiotics due to biofilm formation. TRL1068 was administered via a single pre-surgical intravenous infusion in three sequentially ascending dose groups (6, 15, and 30 mg/kg). Concomitant perioperative antibiotics were pathogen-targeted as prescribed by the treating physician. In this double-blinded study, 4 patients were randomized to receive placebo and 11 patients to receive TRL1068 on day 1, as well as targeted antibiotics for 7 days prior to the scheduled removal of the infected implant and placement of an antibiotic-eluting spacer as the first stage of the standard of care two-stage exchange arthroplasty. No adverse events attributable to TRL1068 were reported. TRL1068 serum half-life was 15–18 days. At day 8, the concentration in synovial fluid was approximately 60% of the blood level and thus at least 15-fold above the threshold for biofilm-disrupting activity in vitro . Explanted prostheses were sonicated to release adherent bacteria for culture, with elimination of the implant bacteria observed in 3 of the 11 patients who received TRL1068, which compares favorably to prior PJI treatments. None of the patients who received TRL1068 had a relapse of the original infection by the end of the study (day 169). CLINICAL TRIALS This study is registered with ClinicalTrials.gov as NCT04763759 .

28 Sep 2023·Antibiotics (Basel, Switzerland)

Monoclonal Antibody Disrupts Biofilm Structure and Restores Antibiotic Susceptibility in an Orthopedic Implant Infection Model.

Article

Author: Turkmani, Amr ; Mamouei, Zeinab ; Li, Alan ; Hart, Christopher M ; Kauvar, Lawrence M ; Stavrakis, Alexandra I ; Blumstein, Gideon W ; Hamad, Christopher ; Ralston, Micah ; Prunet, Nathanael ; Burke, Zachary D C ; Bernthal, Nicholas M ; Kelley, Benjamin V ; Truong, Nicole ; Kavanaugh, Aaron ; Tenorio, Edgar ; Hori, Kellyn ; Cevallos, Nicolas ; Villalpando, Christina

Bacterial biofilms on orthopedic implants are resistant to the host immune response and to traditional systemic antibiotics. Novel therapies are needed to improve patient outcomes. TRL1068 is a human monoclonal antibody (mAb) against a biofilm anchoring protein. For assessment of this agent in an orthopedic implant infection model, efficacy was measured by reduction in bacterial burden of Staphylococcus aureus, the most common pathogen for prosthetic joint infections (PJI). Systemic treatment with the biofilm disrupting mAb TRL1068 in conjunction with vancomycin eradicated S. aureus from steel pins implanted in the spine for 26 of 27 mice, significantly more than for vancomycin alone. The mechanism of action was elucidated by two microscopy studies. First, TRL1068 was localized to biofilm using a fluorescent antibody tag. Second, a qualitative effect on biofilm structure was observed using scanning electron microscopy (SEM) to examine steel pins that had been treated in vivo. SEM images of implants retrieved from control mice showed abundant three-dimensional biofilms, whereas those from mice treated with TRL1068 did not. Clinical Significance: TRL1068 binds at high affinity to S. aureus biofilms, thereby disrupting the three-dimensional structure and significantly reducing implant CFUs in a well-characterized orthopedic model for which prior tested agents have shown only partial efficacy. TRL1068 represents a promising systemic treatment for orthopedic implant infection.

01 Oct 2017·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

A Human Biofilm-Disrupting Monoclonal Antibody Potentiates Antibiotic Efficacy in Rodent Models of both Staphylococcus aureus and Acinetobacter baumannii Infections

Q2 · MEDICINE

Article

Author: Tenorio, Edgar ; Ryser, Stefan ; Xiong, Yan Q. ; Kauvar, Lawrence M. ; Li, L. ; Bayer, Arnold S. ; Gonzales, R. ; Leighton, Anton ; Estellés, Angeles ; Abdelhady, W.

ABSTRACT Many serious bacterial infections are antibiotic refractory due to biofilm formation. A key structural component of biofilm is extracellular DNA, which is stabilized by bacterial proteins, including those from the DNABII family. TRL1068 is a high-affinity human monoclonal antibody against a DNABII epitope conserved across both Gram-positive and Gram-negative bacterial species. In the present study, the efficacy of TRL1068 for the disruption of biofilm was demonstrated in vitro in the absence of antibiotics by scanning electron microscopy. The in vivo efficacy of this antibody was investigated in a well-characterized catheter-induced aortic valve infective endocarditis model in rats infected with a methicillin-resistant Staphylococcus aureus (MRSA) strain with the ability to form thick biofilms, obtained from the blood of a patient with persistent clinical infection. Animals were treated with vancomycin alone or in combination with TRL1068. MRSA burdens in cardiac vegetations and within intracardiac catheters, kidneys, spleen, and liver showed significant reductions in the combination arm versus vancomycin alone ( P < 0.001). A trend toward mortality reduction was also observed ( P = 0.09). In parallel, the in vivo efficacy of TRL1068 against a multidrug-resistant clinical Acinetobacter baumannii isolate was explored by using an established mouse model of skin and soft tissue catheter-related biofilm infection. Catheter segments infected with A. baumannii were implanted subcutaneously into mice; animals were treated with imipenem alone or in combination with TRL1068. The combination showed a significant reduction of catheter-adherent bacteria versus the antibiotic alone ( P < 0.001). TRL1068 shows excellent promise as an adjunct to standard-of-care antibiotics for a broad range of difficult-to-treat bacterial infections.

News (Medical) associated with Calpurbatug

22 Oct 2024

·www.globenewswire.com

Nodenza Venture Partners invests in Trellis Bioscience

Nodenza Venture Partners invests in Trellis Bioscience Lead product TRL1068 targets biofilm, estimated to cause 60-70% of antibiotic resistant infections New York, October 22, 2024 – Nodenza Venture Partners (“Nodenza”), today announces its investment in Trellis Bioscience (“Trellis”), a clinical-stage company focused on discovering and developing native human monoclonal antibodies to treat and prevent drug-resistant, life-threatening infectious diseases. Trellis has developed a patented, proprietary technology (CellSpot) to clone genes of rare fully-human therapeutic monoclonal antibodies (mAbs) from memory B-cells of the blood of individual human donors. CellSpot has identified a high-affinity, broad-spectrum native human antibody, TRL1068, which targets and disrupts bacterial biofilm, a physiological factor promoting drug resistance in most clinically relevant multi-drug-resistant bacteria species, both gram positive and gram negative. TRL1068 is being developed for the treatment of chronic prosthetic joint infection (“PJI”), a chronic infection which requires, as standard of the care, the surgical removal of the prostheses with an estimated cost to the US health system of more than $10bn a year. In addition to PJI, it is estimated that biofilm is the cause of 60-70% of antibiotic resistant infections. TRL1068 has been granted Fast Track and QIDP designations and orphan drug designation for PJI and infective endocarditis by the U.S. Food and Drug Administration (FDA). Chronic PJI always forms biofilms on the prosthesis, thereby shielding the bacteria from eradication by antibiotics, being the reason for PJI to be a difficult-to-treat disease. As biofilm cannot be removed by antibiotics or any other non-invasive treatment, the current standard treatment of chronic PJI is a complex two-stage surgical procedure consisting of removal and replacement of the infected prosthesis. This costly and invasive two-stage process substantially and adversely affects quality of life, with increased immobility and morbidity in addition to decreased 5-year survival rates in patients with PJI when compared with non-infected patients that receive a prosthetic joint replacement. In a clinical proof-of-concept trial, published in a peer-reviewed article in the prestigious AAC Journal, TRL1068 has demonstrated the ability to disrupt the bacterial biofilm barrier to antibiotic access, allowing antibiotics to be efficacious without surgical intervention: In 25% of TRL1068-treated patients, biofilm was removed below the limit of detection after only 7 days of treatment, a finding that has never been observed in this patient population.64% of chronic PJI patients treated with an infusion of a single dose of TRL1068 and standard antibiotics had a bacterial biofilm burden below 100 CFU/mL sonication fluid after only 7 days of treatment. Although the sample size is small (n=11), a favourable comparison to historical data where only 15% of PJI patients are below that mark, suggesting that a treatment period 8 times longer, as planned in a Phase 2 study, will be highly efficacious.TRL1068 was well-tolerated across all three dose groups with no drug-related adverse events.The results of this initial exploratory study have provided strong evidence of efficacy across a diverse set of bacterial species, safety, and pharmacokinetic data to guide the design of a pivotal clinical study of TRL1068 for PJI with the goal to treat the infection without the need for a complex replacement surgery. Ross Morton, Managing Partner of Nodenza Venture Partners, said: “Antibiotic resistance is a significant and growing global threat, with insufficient investment to identify urgently needed new approaches. Trellis stands out with its truly novel and innovative approach to address antibiotic resistance. Through the application of its unique CellSpot technology, Trellis has the potential to be at the forefront of innovation in this critical field. CellSpot and TRL1068 align perfectly with Nodenza Venture Partners’ strategy of identifying and investing in disruptive technologies and therapies with the potential to deliver exceptional benefits to patients. We believe that Trellis has the potential to generate a multi-fold return on for Nodenza.” Stefan Ryser, Ph.D, President & CEO of Trellis Bioscience, commented: “Nodenza’s deep expertise of the pharmaceutical and biotech industry, and their recognition of the novelty of biofilm disruption, makes it an ideal investment partner for Trellis Bioscience as we prepare to advance TRL1068 rapidly through the clinic. The positive data generated to date give us confidence in the potential for a successful clinical study that may result in early FDA marketing authorisation given the five times higher mortality of the PJI standard of care surgery versus an aseptic prostheses replacement as well as the lack of new mechanisms to tackle the specific challenges of prosthetic joint infection. Nodenza has also recognized the enormous potential of TRL1068 beyond PJI as it addresses the broader global threat of antibiotic resistance.” Contacts: Nodenza Venture Partners Ross Morton, Managing Partnerinfo@nodenza.com Mo Advisory PRmo@mopradvisory.comMo Noonan / Jonathan Birt Notes to Editors About Nodenza Venture PartnersNodenza Venture Partners provides financial and operational support to early-stage and pre-commercial biotech and medtech companies and products designed to bring exceptional patient benefit. Our bi-modal investment strategy combines early-stage opportunities – advancing new treatment modalities through active IND to phase 2 - with pre-commercial targets supporting their transition from scientific to commercial companies delivering strong upside potential. Established by a team of experienced life sciences entrepreneurs, founders and leaders, our approach leverages Nodenza’s extensive expertise in the creation and growth of new companies, as well as late-stage product development and launch. For more information visit us at https://www.nodenza.com Trellis BioscienceTrellis Bioscience is a clinical-stage company focused on discovering and developing native human monoclonal antibodies to treat and prevent drug-resistant, life-threatening infectious diseases. Antibodies are the immune system's most potent natural weapon against disease. Trellis's innovative proprietary technology CellSpot™ overcomes technical obstacles that have long hindered exploiting the full human antibody repertoire. This ideal source of drugs focuses on the selection of elite antibodies that bind highly conserved target epitopes with high affinity. To learn more, visit trellisbio.com. Attachment Nodenza Trellis Investment Final

Orphan DrugFast TrackClinical ResultPhase 2Qualified Infectious Disease Product

04 May 2023

·www.biospace.com

Trellis Bioscience Announces Positive Interim Phase 1 Results for TRL1068, a Novel Native Human Monoclonal Antibody Which Reduces Bacterial Biofilm Burden in Chronic Prosthetic Joint Infections

Clinical proof-of-concept has been achieved for TRL1068 in a planned interim analysis based on completion of the second of three escalating dose groups 75% of chronic PJI patients treated with a single dose of TRL1068 and standard antibiotics had a bacterial biofilm burden below 100 CFU/mL sonication fluid after only 7 days of treatment. Although the sample size is small (n=8), this finding compares very favorably to historical data where only 15% of PJI patients are below that mark Remarkably, in a quarter of the TRL1068-treated patients, biofilm was removed below the limit of detection after only 7 days of treatment TRL1068 is well-tolerated across both dose groups with no drug-related adverse events REDWOOD CITY, Calif., May 4, 2023 /PRNewswire/ -- Trellis Bioscience Inc, a clinical stage privately held biotechnology company focused on the discovery and development of native human monoclonal antibodies, today announced a clinical proof-of-concept milestone from a planned interim analysis of the company's Phase 1 trial of its lead antibody, TRL1068 (calpurbatug), in patients with prosthetic joint infections (PJI). TRL1068 has the potential to disrupt bacterial biofilm and thereby enable difficult-to-treat bacterial infections to be treated with standard antibiotics. Six of 8 PJI patients (75%) treated with a single dose of TRL1068 and standard antibiotics had a bacterial biofilm burden below 100 CFU/mL sonication fluid after only 7 days of treatment. This compares very favorably to historical data where only 15% of PJI patients are below 100 CFU/mL sonication fluid. Remarkably, in two of the TRL1068-treated patients, biofilm was removed below the limit of detection. As these are novel findings, Trellis Bioscience is the first company to define the 100 CFU/mL mark to differentiate between high and low bacterial biofilm load on surgically extracted prostheses, and to use historical data of sonication fluid CFU counts as an efficacy measure in PJI. Positive safety and clear trends of efficacy were demonstrated in the first 11 patients randomized across two of three escalating dose groups. "Although the number of TRL1068-treated PJI patients to date is small and the study was not intended to achieve statistical significance for efficacy, the total removal of bacterial biofilm burden in two patients and the trend toward lower biofilm burden in other treated patients after only 7 days of treatment as compared to robust historical data, are very encouraging. Long experience has established that antibiotics alone cannot remove the biofilm burden. At study entry we confirmed the presence of an infection for each subject by growing a culture of a needle aspirate of the joint synovial fluid, a very robust test," said Stefan Ryser, Ph.D, Trellis CEO. These remarkable outcomes provide a foundation for the design of a Phase 2 study aimed at demonstrating that treatment with TRL1068 over a longer time period, in conjunction with standard antibiotic care, can eliminate the infection and thus preserve the original prosthetic joint in patients with PJI. This has the potential to replace the current standard of care, a highly burdensome 2-stage surgical replacement process, with a non-surgical intervention. TRL1068 was well tolerated across both dose groups (6mg/kg and 15mg/kg). No drug-related adverse events were reported, and no dose-limiting toxicities were identified. Enrollment into the third and last dose cohort (30 mg/kg) is in progress. "We are excited about these unexpected positive results. As a physician I would have never thought we would observe eradication of biofilm-embedded bacterial pathogens after only 7 days of treatment in a bacterial biofilm that may have grown over a period of years. Based on our currently available preclinical and clinical data we have the expectation of successfully treating, without the need for surgery, chronic prosthetic joint infections and other infections of implanted medical devices and opening a pathway for the treatment of diabetic foot, pulmonary and many other difficult to eradicate biofilm-associated infections," said Anton Leighton, M.D., Trellis CMO. "I want to thank the patients and their families, the treating physicians and clinical staff, our employees and consultants, and our funders for bringing us to this exciting milestone and for their continued efforts on the study. We are looking forward to completing the ongoing Phase 1 study and continuing clinical development with a novel Phase 2 study design, where we will evaluate the capacity of TRL1068 to spare patients from surgery. Once we can eliminate the biofilm "shield", wherein bacteria are highly resistant to antibiotic treatment, standard antibiotics will become substantially more effective in eliminating this difficult-to-treat disease without the need for surgery," said Trellis CEO, Stefan Ryser, Ph.D. "A further advantage of TRL1068 is that we expect this native human antibody can be administered multiple times without causing neutralizing antibodies. Due to its phenomenal broad-spectrum activity, we should be able to not only treat staphylococcus infections, but the entire gamut of bacterial infections, including enterobacter, enterococcus, streptococcus, propionibacterium, pseudomonas and others that plague PJI patients," said Trellis CSO and founder Larry Kauvar, Ph.D. About Prosthetic Joint Infections The treatment of bacterial infection of implanted medical devices represents a growing unmet need due to the rapidly increasing number of such implants, with over 1 million hip and knee replacements performed each year in the U.S. alone. While these procedures may improve mobility and quality of life, they are associated with complications, including chronic prosthetic joint infections (PJI). Pathogenic bacteria associated with PJI often form biofilms on the prosthesis, thereby shielding the bacteria from eradication by antibiotics, resulting in PJI becoming a difficult-to-treat disease. As biofilm cannot be removed by antibiotics, the current standard treatment of chronic PJI is a two-stage surgical procedure consisting of removal of the infected prosthesis, implant of an antibiotic eluting spacer for several months, and an additional extensive surgical operation to remove the spacer and implant a new prosthesis. This costly and invasive two-stage process substantially and adversely affects quality of life, with increased immobility and morbidity in addition to decreased 5-year survival rates in patients with PJI when compared with noninfected patients that receive a joint replacement. About Clinical Study TRL1068-101 Trellis' clinical study TRL1068-101 is a first-in-human Phase 1, double-blinded, randomized, placebo-controlled single ascending dose study designed to evaluate safety, pharmacokinetics and activity of TRL1068 in subjects with PJI of the knee or hip (ClinicalTrials.gov Identifier: NCT04763759). Subjects are treated with a single infusion of TRL1068 in conjunction with standard antibiotic care for 7 days, prior to receiving primary two-stage exchange arthroplasty, a surgical procedure which is the current standard of care for the treatment of chronic PJI. The study aims to randomize 18 patients across three dose groups. Although designed primarily as a safety clinical trial, the study in infected patients provides an opportunity to gain insight into efficacy. About Trellis Bioscience Inc. Trellis Bioscience is a clinical stage privately held company focused on discovering and developing native human monoclonal antibodies for the treatment and prevention of drug-resistant, life-threatening infectious diseases. Antibodies are the immune system's most potent natural weapon against disease. Trellis's innovative proprietary technology CellSpot™ overcomes technical obstacles that have long hindered exploiting the full human antibody repertoire. This ideal source of drugs has reduced likelihood of toxicity arising from off-target reactivity and increased likelihood of efficacy arising from the selection of elite antibodies from donors who have successfully overcome the disease. Acknowledgement and Disclaimer Research reported in this press release is supported by CARB-X. CARB-X's funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), and Germany's Federal Ministry of Education. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. Contact Stefan Ryser, Ph.D CEO, Trellis Bioscience Inc. 702 Marshall Street, Suite 301 Redwood City, CA 94063 sryser@trellisbio.com Phone (650) 838 1400 View original content to download multimedia: SOURCE Trellis Bioscience Inc.

Clinical ResultPhase 1Phase 2

25 Jan 2023

·www.biospace.com

Methicillin-Resistant Staphylococcus aureus Infection Pipeline Clinical Trials Featuring 25+ companies

New York, USA, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Methicillin-Resistant Staphylococcus aureus Infection Pipeline Clinical Trials Featuring 25+ companies| DelveInsight Methicillin-resistant Staphylococcus aureus (MRSA) is an infection caused by antibiotic-resistant strains of the pathogen Staphylococcus aureus. Rising incidence of Methicillin-resistant Staphylococcus aureus (MRSA) infections is creating health concerns among the population. Manufacturers are focusing on product development and launches for the treatment of Methicillin-resistant Staphylococcus aureus (MRSA). DelveInsight’s 'Methicillin-Resistant Staphylococcus aureus Infection Pipeline Insight 2023' report provides comprehensive global coverage of available, marketed, and pipeline methicillin-resistant Staphylococcusaureus infection therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the methicillin-resistant Staphylococcusaureus infection pipeline domain. Key Takeaways from the Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report DelveInsight’s methicillin-resistant Staphylococcusaureus infection pipeline report depicts a robust space with 25+ companies and 28+ pipeline drugs for methicillin-resistant Staphylococcusaureus infection treatment. Key methicillin-resistant Staphylococcusaureus infection companies include Trellis Bioscience, LegoChem Biosciences, Aptorum Group, ContraFect, Crystalgenomics, Cellics Therapeutics, MicuRx, Oxford Antibiotic Group, Destiny Pharma, TSRL, Inc., TAXIS Pharmaceuticals, Basilea Pharmaceutica, Helperby Therapeutics, Akagera Medicines, Histogen, Alphamab Co. Ltd, Biocidium Pharmaceuticals, and others are evaluating novel methicillin-resistant Staphylococcusaureus infection drugs candidate to improve the treatment landscape. Promising methicillin-resistant Staphylococcusaureus infection pipeline therapies in various stages of development include TRL1068, Delpazolid, ALS 4, Teicoplanin inhalation, CG 400549, SAAP 148, Exebacase, Marinus, CTI 005, Iclaprim, MRX 4, MRX 7, XF-73, TXA709, ARV-1801, ACX-375C, ABX-605, IBT-V02, BCM-0184, Contezolid, TetramOX, Ceftobiprole, HY-004B8b, HY-005B8a, CG-549, Emricasan, KN043, and several others. Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole, is a cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. This includes methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp. In October 2022, Basilea Pharmaceutica announced the results from Phase III ERADICATE study, evaluating ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus. Results for the primary efficacy outcomes were consistent in key subgroups including in patients with MSSA or MRSA bloodstream infections at baseline, and in various categories of underlying conditions such as skin and skin structure infections, abdominal abscesses, chronic dialysis, septic arthritis, osteomyelitis, definite right-sided infective endocarditis and in patients with persistent SAB. Basilea also planned to submit a New Drug Application (NDA) for ceftobiprole to the US Food and Drug Administration (FDA) around year-end 2022. Exebacase (CF-301) being developed by ContraFect Corporation is a lysin with potent activity against Staphylococcus aureus ("Staph aureus"). Exebacase has the potential to be the first-in-class of a new treatment for patients with Staph aureus bacteremia. The FDA has granted Breakthrough Therapy designation to exebacase for the treatment of MRSA bloodstream infections (bacteremia), including right-sided endocarditis, when used in addition to SOC antistaphylococcal antibiotics in adult patients, based on the final data from the Phase II superiority trial of exebacase. In July 2022, Destiny Pharma plc announced that it had received an award from the Cystic Fibrosis Foundation. The research project will establish the potential of the Company’s proprietary XF-73 drug as a novel treatment for cystic fibrosis patients infected with methicillin-resistant Staphylococcus aureus (MRSA). CTI-005 is for the treatment of Methicillin Resistance Staphylococcus Aureus (MRSA) Pneumonia and has been granted IND allowance from the US FDA. The potent RBC-NS has the membrane lipids and receptors that a normal red blood cell has, however, the high surface-volume ratio of the RBC-NS allows it to act as a decoy. This characteristic allows the RBC-NS to bind and neutralize toxins, auto-antibodies, and bacterial infections. The pore-forming toxins emitted by MRSA can be effectively absorbed and neutralized by RBC-NS. Request a sample and discover the recent advances in methicillin-resistant Staphylococcusaureus infection treatment drugs @ Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report The methicillin-resistant Staphylococcusaureus infection pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage methicillin-resistant Staphylococcusaureus infection products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the methicillin-resistant Staphylococcusaureus infection pipeline landscape. Methicillin-Resistant Staphylococcus aureus Infection Overview Methicillin-resistant Staphylococcus aureus (MRSA) infections are caused by bacteria that have attained resistance from several antibiotics that treat diseases caused by Staphylococcus bacteria. The common patients of Methicillin-resistant Staphylococcus aureus (MRSA) infections are patients that have been in hospitals or healthcare settings for a long duration where the bacteria is found commonly. MRSA infections are known as healthcare-associated MRSA (HA-MRSA) if infected in hospitals. Such infections can spread to healthcare workers through invasive procedures, which are further transmitted to several patients by touching and operating with bare hands. Other MRSA infections occur in a considerable population of healthy people. People associated with community-associated MRSA (CA-MRSA) show symptoms appearing as painful skin boils. It further spreads through physical contact between individuals. The population at higher risk includes people surrounded by a significant number of people and childcare workers. MRSA infections might look like red bumps, pimples, or spider bites, accompanied by pus and fever. Find out more about methicillin-resistant Staphylococcusaureus infection treatment drugs @ Drugs for Methicillin-Resistant Staphylococcus aureus Infection Treatment A snapshot of the Methicillin-Resistant Staphylococcus aureus Infection pipeline drugs mentioned in the report: Drug Company Phase MoA RoA Ceftobiprole Basilea Pharmaceutica Phase III Cell wall inhibitors; Peptidyltransferase inhibitors Intravenous CG 549 CrystalGenomics Phase II Enoyl-ACP reductase inhibitors; Fatty acid synthase expression inhibitors; Fatty acid synthetase complex inhibitors Oral BCM-0184 Biocidium Pharmaceuticals Phase I NA Oral/Topical TRL1068 Trellis Bioscience Phase I Bacterial biofilm inhibitors Intravenous ALS 4 Aptorum Group Phase I Bacterial virulence inhibitors Oral EVX-B1 Evaxion Biotech Preclinical Immunostimulants NA Emricasan Histogen Preclinical Apoptosis inhibitors; Caspase inhibitors NA TarO inhibitor Prokaryotics Discovery Cell membrane inhibitors; Cell wall inhibitors NA Learn more about the emerging methicillin-resistant Staphylococcusaureus infection pipeline therapies @ Methicillin-Resistant Staphylococcus aureus Infection Clinical Trials Methicillin-Resistant Staphylococcus aureus Infection Therapeutics Assessment The methicillin-resistant Staphylococcus aureus infection pipeline report proffers an integral view of methicillin-resistant Staphylococcusaureus infection emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Pre-clinical, Discovery, Discontinued, Inactive, Phase I, Phase II, Phase III Therapeutics AssessmentBy Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical. Therapeutics AssessmentBy Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics AssessmentBy Mechanism of Action: Cell wall inhibitors; Peptidyltransferase inhibitors, Enoyl-ACP reductase inhibitors; Fatty acid synthase expression inhibitors; Fatty acid synthetase complex inhibitors, Bacterial biofilm inhibitors, Bacterial virulence inhibitors, Immunostimulants, Apoptosis inhibitors; Caspase inhibitors, Cell membrane inhibitors; Cell wall inhibitors Key Methicillin-Resistant Staphylococcus aureus Infection Companies: Trellis Bioscience, LegoChem Biosciences, Aptorum Group, ContraFect, Crystalgenomics, Cellics Therapeutics, MicuRx, Oxford Antibiotic Group, Destiny Pharma, TSRL, Inc., TAXIS Pharmaceuticals, Basilea Pharmaceutica, Helperby Therapeutics, Akagera Medicines, Histogen, Alphamab Co. Ltd, Biocidium Pharmaceuticals, and others. Key Methicillin-Resistant Staphylococcus aureus Infection Pipeline Therapies: TRL1068, Delpazolid, ALS 4, Teicoplanin inhalation, CG 400549, SAAP 148, Exebacase, Marinus, CTI 005, Iclaprim, MRX 4, MRX 7, XF-73, TXA709, ARV-1801, ACX-375C, ABX-605, IBT-V02, BCM-0184, Contezolid, TetramOX, Ceftobiprole, HY-004B8b, HY-005B8a, CG-549, Emricasan, KN043, and others. Dive deep into rich insights for new drugs for methicillin-resistant Staphylococcusaureus infection treatment; visit @ Methicillin-Resistant Staphylococcus aureus Infection Drugs Table of Contents 1. Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report Introduction 2. Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report Executive Summary 3. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. Methicillin-Resistant Staphylococcus aureus Infection Pipeline Therapeutics 6. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Late Stage Products (Pre-registration) 7. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Late Stage Products (Phase III) 7.1 Ceftobiprole: Basilea Pharmaceutica 8. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Mid Stage Products (Phase II) 8.1 CG549: CrystalGenomics 9. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Early Stage Products (Phase I) 9.1 TRL1068: Trellis Bioscience 10. Methicillin-Resistant Staphylococcus aureus Infection Pipeline Therapeutics Assessment 11. Inactive Products in the Methicillin-Resistant Staphylococcus aureus Infection Pipeline 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Key Companies 14. Key Products in the Methicillin-Resistant Staphylococcus aureus Infection Pipeline 15. Unmet Needs 16. Market Drivers and Barriers 17. Future Perspectives and Conclusion 18. Analyst Views 19. Appendix For further information on the methicillin-resistant Staphylococcusaureus infection pipeline therapeutics, reach out @ Methicillin-Resistant Staphylococcus aureus Infection Treatment Drugs Related Reports Methicillin-Resistant Staphylococcus aureus Epidemiology Forecast Methicillin-Resistant Staphylococcus aureus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the methicillin-resistant Staphylococcusaureus epidemiology trends. Methicillin-Resistant Staphylococcus aureus Infection Market Methicillin-Resistant Staphylococcus aureus Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key methicillin-resistant Staphylococcusaureus infection companies, including Trellis Bioscience, LegoChem Biosciences, Aptorum Group, Allergan, iNtRON Biotechnology, Neupharma, ImmuPharma, Lytix Biopharma, CrystalGenomics, AIMM Therapeutics, among others. Staphylococcus aureus Bacteremia Pipeline Staphylococcus aureus Bacteremia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug pro including clinical and non-clinical stage products, and the key Staphylococcus aureus Bacteremia companies, including ContraFect, Armata Pharmaceuticals, iNtRON Biotechnology, Durata Therapeutics, Cipher Pharmaceuticals, XBiotech, Basilea Pharmaceutica, Genentech, among others. Hospital Acquired Methicillin-Resistant Staphylococcus aureus Infections Pipeline Hospital Acquired Methicillin-Resistant Staphylococcus aureus Infections Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug pro including clinical and non-clinical stage products, and the key Hospital Acquired Methicillin-Resistant Staphylococcus aureus Infections companies, including Trellis Bioscience, LegoChem Biosciences, Aptorum Group, Allergan, iNtRON Biotechnology, Neupharma, ImmuPharma, Lytix Biopharma, CrystalGenomics, AIMM Therapeutics, among others. Other Trending Reports Treatment Resistant Depression Market | Advanced Renal Cell Carcinoma Market | Brain Cancer Market | Centronuclear Myopathy Market | Head And Neck Squamous Cell Carcinoma Market | Acquired Immunodeficiency Syndrome Market | Acute Intermittent Porphyria Market | Neurovascular Devices Market | Defibrillators Market | Ventricular Hypertrophy Market | Urolithiasis Market | Alopecia Areata Market | Autonomic Dysfunction Market | Acute Ischemic Stroke Ais Market | Adenoid Cystic Carcinoma Market | Aspergillosis Market | Biliary Atresia Market | Biliary Tumor Market | Chronic Inducible Urticaria Market | Chronic Insomnia Market | Critical Limb Ischemia Market | Endometriosis Pain Market | Generalized Anxiety Disorder Gad Market | Hallux Valgus Market | Hemophilia B Market | Immunologic Deficiency Syndrome Market | Neuroblastoma Market | Neuromodulation Devices Market | Neurovascular Thrombectomy Devices Market | Osteosarcoma Market | Pemphigus Vulgaris Market | Progressive Familial Intrahepatic Cholestasis Market | Pruritus Market | Radiation Toxicity Market | Pulmonary Hypertension Associated With Interstitial Lung Disease Market | Cluster Headaches Market | Foot And Ankle Devices Market | Intravenous Immunoglobulin Market | Bile Duct Neoplasm Market | Blood Glucose Monitoring Systems Market | Rett Syndrome Market | Tissue Heart Valves Market | Cardiac Biomarkers Testing Devices Market | Subscription Healthcare | Hepatorenal Syndrome Market | Central Venous Catheters Market | Continuous Renal Replacement Therapy Machines Market | Nonalcoholic Steatohepatitis Market | Necrotizing Enterocolitis Market | Cardiac Amyloidosis Market | Artificial Iris Market | Aortic Aneurysm Stent Grafts Market | Polypoidal Choroidal Vasculopathy Market | Adrenal Crisis Market | Hearing Implants Market | Image Guided Surgery Devices Market | Angioedema Market | Bladder Cancer Market Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us atLinkedIn Contact Us Shruti Thakur info@delveinsight.com +1(919)321-6187

Phase 3Phase 2Clinical Result

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Indication	Highest Phase	Country/Location	Organization	Date
Prosthetic joint infection	Phase 2	-	Trellis Bioscience, Inc.	01 Jan 2025
Chronic rhinosinusitis with nasal polyps	Phase 1	-	Trellis Bioscience, Inc.	01 Jan 2024
Endocarditis, Bacterial	Preclinical	US	Trellis Bioscience, Inc.	10 Jun 2024
Staphylococcus Aureus Infections	Preclinical	US	Trellis Bioscience, Inc.	01 Apr 2016

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