Community-Acquired Infections

-- Highlights include data from clinical, non-clinical and microbiology programs, real-world patient use and a five-year microbiologic surveillance study of NUZYRA BOSTON, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, announces that data from several new studies of NUZYRA® (omadacycline) will be presented at IDWeek 2024, Oct. 16-19 at the Los Angeles Convention Center in Los Angeles, CA. “We continue to invest in science as part of our continued commitment to furthering the medical community’s understanding of NUZYRA’s potential utility across a broad range of serious, community-acquired infections, including pulmonary and skin infections,” said Randy Brenner, chief development and regulatory officer of Paratek. “Notably, researchers will share the interim safety results of an open-label, non-inferiority trial of NUZYRA in the treatment of bone and joint infections as well as data from a real-world study assessing both clinical and microbiological outcomes of treatment with NUZYRA for pulmonary Mycobacterium abscessus complex, a rare pulmonary disease that Paratek is also evaluating in a Phase 2 study.” Oral Presentations Abstract title: Improving Traditional Registrational Trial Endpoints: Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin-Structure InfectionsSession: Breaking Ground: ID Clinical TrialsPresenter: Jessica Renee Howard-Anderson, M.D., M.Sc. (Independent research)Session Date, Time: Thursday, Oct. 17; 10:30 a.m. - 11:45 a.m. (PT) Session Location: 404 ABSubmission ID: 1828901 Abstract title: Evaluation of Fecal Pharmacokinetics and Metagenomic Changes Following the Administration of Intravenous Omadacycline to Healthy SubjectsSession: Hot Topics in Microbiome SciencePresenter: Kevin Garey, Pharm.D. (Investigator-initiated research)Session Date, Time: Friday, Oct. 18; 3:15 p.m. - 4:30 p.m. (PT)Session Location: 411Submission ID: 1828708 Abstract title: Clinical and Microbiological Outcomes of Omadacycline for Pulmonary Mycobacterium Abscessus Complex Session: TB and Nontuberculous Mycobacteria UpdatesPresenter: Mohammed Al Musawa, Pharm.D., BCIDP (Investigator-initiated research)Session Date, Time: Saturday, Oct. 19; 3:15 p.m. - 4:30 p.m. (PT) Session Location: 403 ASubmission ID: 1828690 Poster Sessions Poster title: Safety of Omadacycline Versus Standard-of-Care Oral Antibiotic Treatment for Bone and Joint Infections: Interim Results from an Open-Label, Non-Inferiority, Randomized Controlled Trial Poster Session Title: Bone and JointPresenter: Amy Y. Kang, Pharm.D., BCIDP (Investigator-initiated research)Date, Time: Thursday, Oct. 17; 12:15 p.m. - 1:30 p.m. (PT) Location: Hall J & KSubmission ID: 1828407 Rapid Fire and Poster title: Activity of Omadacycline Against 35,000 Bacterial Clinical Isolates and Resistant Organism Subsets from Patients in the United States (2019–2023)Poster session: HAIs: SurveillancePresenter: Michael Huband, B.S. (Paratek research)Date, Time: Thursday, Oct. 17, 2024; 12:15 p.m. - 1:30 p.m. (PT)Location: Hall J & KSubmission ID: 1817385 Poster title: In Vitro Activity of Omadacycline and Comparator Agents against a Collection of Neisseria Gonorrhoeae Urine Isolates Collected from the United States During 2018-2020 Poster session: Treatment of Antimicrobial Resistant InfectionsPresenter: S.J. Ryan Arends, Ph.D. (Paratek research)Date, Time: Friday, Oct. 18; 12:15 p.m. - 1:30 p.m. (PT)Location: Hall J & KSubmission ID: 1829425 Poster title: Current Prescribing Practices and Guideline Concordance for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) across Outpatient and Urgent Care Visits Poster session: Antibiotic Stewardship: Non-Inpatient SettingsPresenter: Tomefa Asempa, Pharm.D. (Investigator-initiated research)Date, Time: Saturday, Oct. 19, 12:15 p.m. - 1:30 p.m. (PT)Location: Hall J & KSubmission ID: 1827423 About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab Limited for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Zai Lab received approval for both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration of China for the treatment of CABP and ABSSSI in December 2021 and in Macao for the treatment of CABP and ABSSSI in May 2023. Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter. About NUZYRA®NUZYRA® (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients. WARNINGS AND PRECAUTIONSMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONSThe most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONSPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. USE IN SPECIFIC POPULATIONSLactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. MEDIA CONTACT: Christine Fanelle Scient PR Christine@ScientPR.com215-595-5211

LimmaTech receives an exclusive clinical development license from AbVacc for a multivalent, toxoid vaccine candidate to prevent infections caused by Staphylococcus aureus, the leading cause of antimicrobial resistance-related deaths in the U.S. and Europe LimmaTech will initiate Phase 1 clinical development of the vaccine candidate in 2024 with an option to acquire full worldwide rights after the trial readout SCHLIEREN, Switzerland & ROCKVILLE, Md.--(BUSINESS WIRE)-- LimmaTech Biologics and AbVacc announced today a license agreement that grants LimmaTech the exclusive rights to further develop AbVacc’s multivalent toxoid vaccine candidate, LBT-SA7 (formerly IBT-V02), designed to prevent infections caused by the bacterial pathogen, Staphylococcus aureus (S. aureus). LimmaTech also receives an exclusive option, executable post Phase 1 read-out, to acquire full rights to the program. No further details of the transaction have been disclosed. This press release features multimedia. View the full release here: LBT-SA7 is a six valent toxoid vaccine candidate, designed and developed to date by AbVacc for the prevention of recurrent skin and soft tissue infections (SSTI) caused by S. aureus. The vaccine candidate contains weakened forms of toxins, referred to as toxoids, that would normally be secreted by the pathogen to cause an infection. The unique formulation of LBT-SA7 enables the body to fight against the infection by eliciting an immune response against the original S. aureus toxins. Preclinical studies in mice and rabbits demonstrated strong neutralizing activity against several clinically relevant forms of S. aureus infection. The vaccine candidate also showed efficacy in non-naïve mice pre-exposed to the pathogen. “S. aureus-related infections remain an urgent global medical priority, for which there is no vaccine currently available. Based on the original scientific work and the promising preclinical data generated by AbVacc, we aim to rapidly start clinical development and deliver an effective intervention for patients with a broad range of S. aureus infections,” said Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech. “Building on our extensive vaccine development expertise, including against S. aureus, adding this program to our pipeline is a key milestone in our strategy to pursue innovative approaches to prevent increasingly untreatable microbial infections and positively impact the dangerous rise of antimicrobial resistance.” Javad Aman, PhD, President & Chief Scientific Officer of AbVacc stated, “This product candidate has the potential to solve the pressing medical need for SSTIs, by effectively preventing its recurrence. We highly value the LimmaTech team’s depth of experience and extensive know-how that will contribute to achieving successful clinical development moving forward.” Michael Kowarik, PhD, Chief Scientific Officer of LimmaTech added, “We are convinced that this S. aureus toxoid vaccine candidate has the potential to solve the challenges posed by targeting S. aureus surface antigens by addressing a new mechanism of action that has not been explored before.” AbVacc has been part of the Novo Holdings REPAIR Impact Fund's portfolio since 2019. Financial support from REPAIR, combined with grants from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the National Institutes of Health, has bolstered the preclinical development of the IBT-V02 vaccine program. This has led to Phase 1 trial readiness, advancing a potential new tool in the fight against antimicrobial infections towards clinical trials. Development of the LBT-SA7 (formerly IBT-V02) vaccine candidate has been funded in part by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health under award numbers R43AI085665 and R01AI111205 and 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), Germany’s Federal Ministry of Education and Research (BMBF), and the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC). 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. About Staphylococcus aureus Staphylococcus aureus (S. aureus), a Gram-positive bacterial pathogen, affects approximately 30% of the human population while causing a spectrum of infections, from skin and soft tissue infections (SSTI) to severe conditions like pneumonia and bloodstream infections. S. aureus is the leading cause of antimicrobial resistance (AMR)-attributed fatalities with community-acquired and hospital-acquired infections being the most prevalent. SSTI caused by S. aureus range from mild to severe and entail microbial invasion into the skin layers and underlying soft tissues. Traditional antibiotic treatments, both oral therapy and intravenous administration reserved for severe cases, have become increasingly less effective due to the rise of antibiotic resistance. S. aureus has been designated as a "high priority" pathogen by the World Health Organization (WHO), underscoring the urgency for innovative vaccine approaches and effective treatment strategies. About AbVacc AbVacc, Inc., a recent spin-off of Integrated Biotherapeutics, uses structure-guided rational design for the discovery and development of next generation “smart” vaccines and monoclonal antibodies. AbVacc’s portfolio includes vaccines and antibodies for serious emerging infectious diseases such as methicillin-resistant S. aureus (MRSA), C. difficile, B. anthracis, filoviruses Ebola, Sudan, and Marburg, Nipah virus, and Influenza at mid-to-late preclinical stages, and several more candidates in early discovery stage. AbVacc’s S. aureus vaccine (IBT-V02) has been supported by investments from the U.S. National Institute of Allergy and Infectious Diseases, CARB-X, and Novo Holdings. For more information please visit . About LimmaTech Biologics LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. For more information, please visit . View source version on businesswire.com: Contacts For AbVacc: Javad Aman, President and CSO Email: Jaman@AbVacc.com For LimmaTech Biologics: Franz-Werner Haas, CEO E-Mail: media@lmtbio.com Media inquiries for LimmaTech Biologics: Jacob Verghese or Gretchen Schweitzer Trophic Communications Phone: +49 151 7441 6179 Email: limmatech@trophic.eu Source: LimmaTech Biologics View this news release online at:

INNA-051 increased early expression of multiple antiviral effector genes compared with placebo and shortened viral shedding duration in participants with confirmed influenza infection MELBOURNE, Australia and MILAN, Italy, Sept. 11, 2023 (GLOBE NEWSWIRE) -- ENA Respiratory, a clinical-stage pharmaceutical company, announced positive data from the Phase 2a flu challenge study of INNA-051, a first-in-class, broad-spectrum, innate immunomodulator in development for the prophylaxis of complications associated with respiratory viral infections. As previously reported, data from post-hoc analyses excluding those with pre-existing immunity against the challenge virus strain showed that INNA-051-treated participants with laboratory-confirmed infection had a statistically significant shorter duration of infection. New data reported today show that in this population, INNA-051 resulted in early stimulation of multiple genes that play important roles in the response to viral infections, including type I and III interferons. These results support the observed accelerated viral clearance. The biomarker data were presented in a late-breaking abstract oral session and the clinical data were discussed at a poster session at the European Respiratory Society meeting, which is taking place in Milan, Italy, September 9-13. “The data presented today support the clinical potential of INNA-051 in individuals at risk for more severe outcomes resulting from viral respiratory infections,” said Christophe Demaison PhD, Managing Director and CEO of ENA Respiratory. “These data provide important insights into the molecular mechanisms that underlie the observed decrease in duration of infection in this flu challenge study. Together with our Phase 1 and preclinical data, the results provide a clear rationale for the continued clinical development of INNA-051 in the context of natural respiratory tract infections in individuals with increased risk of severe illness.” The Phase 2a flu challenge study included 123 adults (ages 19 to 53) randomized to receive two doses of INNA-051 (low and high dose) or placebo, then challenged with a substantial dose of H3N2 (A/Perth/16/2009) influenza A virus. Clinical results from the study were presented in a poster titled “INNA-051 pre-exposure prophylaxis in a human influenza infection model” (Poster #40831). INNA-051 safety and tolerability pro the influenza challenge study was found to be consistent with data from Phase I in adults aged 18-80 and further supports its use in a prophylaxis setting. Key findings from post hoc analyses conducted on participants with PCR-confirmed infection and no or low antibody titer against the challenged virus at quarantine admission, include: Statistically significant reduction in the duration of viral shedding as measured by qRT-PCR detectable viral nucleic acid in the INNA-051 high-dose group relative to placebo. Trend towards a shorter duration of clinical symptoms with the INNA-051 high dose. Additional data from the study were presented in a late-breaking oral presentation titled “INNA-051 prophylaxis enhances innate immune responses confirming accelerated viral clearance in a human influenza challenge model” (Abstract #42457). Expression of 730 immune genes was assessed in nasal swabs obtained following influenza challenge from participants included in the post-hoc analysis. Key findings include: Early increase in the expression of genes involved in the influenza host response in the INNA-051 treatment group compared to placebo, including genes for proteins known to have direct antiviral effects against influenza. Higher early expression of key interferon genes in the INNA-051 treatment group compared to placebo. “These findings clearly demonstrate that INNA-051 is associated with increased stimulation of multiple genes and pathways known to play essential roles in the innate immune response against influenza and is consistent with the accelerated viral clearance observed in the clinical efficacy data,” said Ruth Tal-Singer PhD, Medicine Development Leader, ENA Respiratory. “The continued evolution of respiratory viruses like those that cause long-COVID or influenza complications further underscores the critical need for novel approaches to boosting innate immunity against respiratory infections in vulnerable populations The data reported today increase our confidence that INNA-051 has the potential to play an important role in preventing or mitigating the severity of viral respiratory diseases.” A Phase 2b study in community-acquired infections in people at risk of complications is planned. Notes to Editors If you would like to arrange an interview, please contact: Glenn Silver, Finn Partners, +1 973 818 8198, glenn.silver@finnpartners.com About ENA Respiratory and INNA-051 ENA Respiratory is a clinical-stage pharmaceutical company developing innate immune modulators for the prevention of complications associated with respiratory viral infections in at-risk populations, including the elderly, those with chronic lung conditions and individuals with occupational risk (e.g. first responders, military or essential services personnel). The company is also developing its innate immune modulators as vaccine adjuvants. ENA Respiratory is based in Melbourne and Sydney, Australia, and it has secured a Series A investment from Brandon Capital Partners’ managed funds, the Minderoo Foundation, and Uniseed. In 2022, ENA Respiratory partnered with the US-based COPD Foundation to accelerate the clinical development of INNA-051 in COPD through its access to patients, a global network of accredited centres, scientific expertise, and patient investigators. That year, the company was also the first in the Asia Pacific region to be selected to join BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate next-gen potential solutions for future pandemics. In 2023, the company was additionally awarded a USD4.38 million contract from the U.S. Department of Defense to support the ongoing development of INNA-051. INNA-051 is a potent TLR2/6 agonist that is delivered using a convenient nasal spray to target the preferential site of initial replication of viral respiratory infections. Fast-acting and inducing a durable biologic response supporting weekly administration, INNA-051 works by recruiting innate immune cells and priming epithelial cells of the nasal mucosa to respond more quickly to infections, rapidly eliminating viruses and other pathogens before they spread throughout the body. In preclinical studies, INNA-051 and close analogues were shown to be effective against multiple respiratory viruses, including SARS-CoV-2, influenza (H1N1 and seasonal H3N2), and rhinovirus. For more information, please visit .