A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

Start Date02 Sep 2022

Sponsor / Collaborator

Aridis Pharmaceuticals, Inc.

NCT02296320

/ CompletedPhase 2

A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects.

Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

Start Date10 Oct 2014

Sponsor / Collaborator

MedImmune LLC

[+2]

NCT01769417

/ CompletedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Extended Half-Life Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin, in Healthy Adult Subjects

This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.

Start Date01 Jan 2013

Sponsor / Collaborator

MedImmune LLC

100 Clinical Results associated with Suvratoxumab

100 Translational Medicine associated with Suvratoxumab

100 Patents (Medical) associated with Suvratoxumab

Literatures (Medical) associated with Suvratoxumab

01 Jan 2024·Cell reports. Medicine

The characteristics of pre-existing humoral imprint determine efficacy of S. aureus vaccines and support alternative vaccine approaches

Article

Author: Du, Xin ; Caldera, J R ; Trieu, Desmond ; Lin, Brian ; Gonzalez, Cesia ; Hajam, Irshad A ; Tsai, Chih-Ming ; Liu, George Y

The failure of the Staphylococcus aureus (SA) IsdB vaccine trial can be explained by the recall of non-protective immune imprints from prior SA exposure. Here, we investigate natural human SA humoral imprints to understand their broader impact on SA immunizations. We show that antibody responses against SA cell-wall-associated antigens (CWAs) are non-opsonic, while antibodies against SA toxins are neutralizing. Importantly, the protective characteristics of the antibody imprints accurately predict the failure of corresponding vaccines against CWAs and support vaccination against toxins. In passive immunization platforms, natural anti-SA human antibodies reduce the efficacy of the human monoclonal antibodies suvratoxumab and tefibazumab, consistent with the results of their respective clinical trials. Strikingly, in the absence of specific humoral memory responses, active immunizations are efficacious in both naive and SA-experienced mice. Overall, our study points to a practical and predictive approach to evaluate and develop SA vaccines based on pre-existing humoral imprint characteristics.

20 Jul 2022·Journal of clinical microbiology

Performance of the Cepheid Methicillin-Resistant Staphylococcus aureus/S. aureus Skin and Soft Tissue Infection PCR Assay on Respiratory Samples from Mechanically Ventilated Patients for S. aureus Screening during the Phase 2 Double-Blind SAATELLITE Study

Article

Author: Huberlant, Vincent ; Bretonniere, Cedric ; Bellamy, Terramika ; Sellman, Bret R. ; Laterre, Pierre-François ; Hernandez Padilla, Ana Catalina ; Ruzin, Alexey ; McCarthy, Michael ; Colbert, Susan ; François, Bruno ; Viña, Lucia ; Esser, Mark T. ; Pugin, Jérôme ; Ali, S. Omar ; Dequin, Pierre-François ; Eggimann, Philippe ; Vandamme, Drieke ; Sánchez-Garcia, Miguel ; Ren, Pin ; Yu, Li ; Jafri, Hasan S. ; Vignaud, Julie ; Shoemaker, Kathryn ; Trenado, José ; Barraud, Olivier ; Lammens, Christine ; Boulain, Thierry ; Goossens, Herman

We investigated the performance of the Xpert methicillin-resistant Staphylococcus aureus (MRSA)/ S. aureus skin and soft tissue (SSTI) quantitative PCR (qPCR) assay in SAATELLITE, a multicenter, double-blind, phase 2 study of suvratoxumab, a monoclonal antibody (MAb) targeting S. aureus alpha-toxin, for reducing the incidence of S. aureus pneumonia.

01 Sep 2021·The Lancet. Infectious diseasesQ1 · MEDICINE

Efficacy and safety of suvratoxumab for prevention of Staphylococcus aureus ventilator-associated pneumonia (SAATELLITE): a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial

Q1 · MEDICINE

Article

BACKGROUND:

Staphylococcus aureus remains a common cause of ventilator-associated pneumonia, with little change in incidence over the past 15 years. We aimed to evaluate the efficacy of suvratoxumab, a monoclonal antibody targeting the α toxin, in reducing the incidence of S aureus pneumonia in patients in the intensive care unit (ICU) who are on mechanical ventilation.

METHODS:

We did a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial at 31 hospitals in Belgium, the Czech Republic, France, Germany, Greece, Hungary, Portugal, Spain, and Switzerland. Eligible patients were in the ICU, aged ≥18 years, were intubated and on mechanical ventilation, were positive for S aureus colonisation of the lower respiratory tract, as assessed by quantitative PCR (qPCR) analysis of endotracheal aspirate, and had not been diagnosed with new-onset pneumonia. Patients were excluded if they had confirmed or suspected acute ongoing staphylococcal disease; had received antibiotics for S aureus infection for more than 48 h within 72 h of randomisation; had a Clinical Pulmonary Infection Score of 6 or higher; had an acute physiology and chronic health evaluation II score of 25 or higher with a Glasgow coma scale (GCS) score of more than 5, or an acute physiology and chronic health evaluation II score of at least 30 with a GCS score of 5 or less; had a Sequential Organ Failure Assessment score of 9 or higher; or had active pulmonary disease that would impair the ability to diagnose pneumonia. Colonised patients were randomly assigned (1:1:1), by use of an interactive voice or web response system, to receive either a single intravenous infusion of suvratoxumab 2000 mg, suvratoxumab 5000 mg, or placebo. Randomisation was done in blocks of size four, stratified by country and by whether patients had received systemic antibiotics for S aureus infection. Patients, investigators, and study staff involved in the treatment or clinical evaluation of patients were masked to patient assignment. The primary efficacy endpoint was the incidence of S aureus pneumonia at 30 days, as determined by a masked independent endpoint adjudication committee, in all patients who received their assigned treatment (modified intention-to-treat [ITT] population). Primary safety endpoints were the incidence of treatment-emergent adverse events at 30 days, 90 days, and 190 days after treatment, and the incidence of treatment-emergent serious adverse events, adverse events of special interest, and new-onset chronic disease at 190 days after treatment. All primary safety endpoints were assessed in the modified ITT population. This trial is registered with ClinicalTrials.gov (NCT02296320) and the EudraCT database (2014-001097-34).

FINDINGS:

Between Oct 10, 2014, and April 1, 2018, 767 patients were screened, of whom 213 patients with confirmed S aureus colonisation of the lower respiratory tract were randomly assigned to the suvratoxumab 2000 mg group (n=15), the suvratoxumab 5000 mg group (n=96), or the placebo group (n=102). Two patients in the placebo group did not receive treatment after randomisation because their clinical conditions changed and they no longer met the eligibility criteria for dosing. As adjudicated by the data monitoring committee at an interim analysis, the suvratoxumab 2000 mg group was discontinued on the basis of predefined pharmacokinetic criteria. At 30 days after treatment, 17 (18%) of 96 patients in the suvratoxumab 5000 mg group and 26 (26%) of 100 patients in the placebo group had developed S aureus pneumonia (relative risk reduction 31·9% [90% CI -7·5 to 56·8], p=0·17). The incidence of treatment-emergent adverse events at 30 days were similar between the suvratoxumab 5000 mg group (87 [91%]) and the placebo group (90 [90%]). The incidence of treatment-emergent serious adverse events at 30 days were also similar between the suvratoxumab 5000 mg group (36 [38%]) and the placebo group (32 [32%]). No significant difference in the incidence of treatment-emergent adverse events between the two groups at 90 days (89 [93%] in the suvratoxumab 5000 mg group vs 92 [92%] in the placebo group) and at 190 days (93 [94%] vs 93 [93%]) was observed. 40 (40%) patients in the placebo group and 50 (52%) in the suvratoxumab 5000 mg group had a serious adverse event at 190 days. In the suvratoxumab 5000 mg group, one (1%) patient reported at least one treatment-emergent serious adverse event related to treatment, two (2%) patients reported an adverse event of special interest, and two (2%) reported a new-onset chronic disease.

INTERPRETATION:

In patients in the ICU receiving mechanical ventilation with qPCR-confirmed S aureus colonisation of the lower respiratory tract, the incidence of S aureus pneumonia at 30 days was not significantly lower following treatment with 5000 mg suvratoxumab than with placebo. Despite these negative results, monoclonal antibodies still represent one promising therapeutic option to reduce antibiotic consumption that require further exploration and studies.

FUNDING:

AstraZeneca, with support from the Innovative Medicines Initiative Joint Undertaking.

News (Medical) associated with Suvratoxumab

20 Dec 2024

·www.globenewswire.com

Aridis Provides Corporate Update

LOS GATOS, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (OTC: ARDS) (“Aridis” or the “Company”), a biopharmaceutical company, today announced a corporate update on recent developments. Company update: The Company continues to diligently explore multiple paths to monetize its assets amidst a protracted challenging capital market and limited internal resources. During the second half of this year it has been in discussions with other pharmaceutical companies and investment firms on possible partnerships and investments in the clinical product candidates AR-301, AR-320, AR-501, and the APEX platform technology. The Company has substantially reduced its operational cash burn by delaying the expenses associated with SEC filings in favor of business development discussions with potential partners and investors. As a result of voluntary non-compliance, the Company was transitioned to and expects to continue to be listed on the OTC Expert Market until a positive outcome(s) from the business development effort on one or more of its programs. Importantly, two promising developments have been achieved involving the lead assets AR-301 and AR-501 that, if realized, are expected to generate near term revenues and shareholder value: Phase 2 product candidate AR-501 The Company recently executed an Asset Acquisition Terms Agreement with an undisclosed pharmaceutical company (Partner) to assign exclusive ownership of AR-501 upon receiving the Partner’s payments totaling $6,500,000. Two payments of $3,250,000 each are expected to be received in the first and second quarter of 2025, respectively. The Partner is further obligated to make annual royalty payments to Aridis of 12% to 15% of the net sales revenue for up to 10 years following the first commercial sale. Development status: AR-501 is being developed as a therapeutic treatment for chronic bacterial lung infections in cystic fibrosis (CF) patients. A Phase 1 trial in healthy adults and a Phase 2a trial in cystic fibrosis patients have been completed. The primary endpoint of safety was achieved in both studies, showing that AR-501 was well tolerated when administered as an inhaled dosage form over several weekly treatments. The pharmacokinetic data showed effective delivery of AR-501 into the lungs of CF patients and a fast clearance rate. The positive clinical trial data also facilitated the filing for non-dilutive grant funding support from governmental sources and non-governmental organizations (NGOs), which we intend to explore. Lead product candidate AR-301 The discussions with potential partners and investors to continue the development of AR-301 resulted in an investment proposal from a globally recognized private investment firm in an amount that the Company believes is sufficient to complete the second and final Phase 3 study and product approval. The Company is working closely with the investment firm to satisfy specific requirements for the closing of investment. Details of the investment proposal and the progress toward investment closing are expected to be disclosed in 1Q25. Development status: AR-301 is being evaluated for the adjunctive therapeutic treatment of Ventilator Associated Pneumonia (VAP). The first of two planned Phase 3 clinical trials saw significant reduction in patient enrollment that was brought about by the COVID-19 pandemic, resulting in an under-powered study. However, despite a small sample size, a positive efficacy trend in favor of AR-301 in VAP patients was observed (p=0.242 at day 21). Remarkably, in a prespecified subpopulation of adults 65 years and older, the efficacy signal was increased by approximately 300%, reaching statistical significance level (p=0.056 at day 21 and p=0.025 at day 28 post-treatment). Furthermore, AR-301 treated patients had a median reduction of length of stay in the intensive care unit (ICU) and hospital by 7 days and by 9 days in the over 65 subpopulation. The clinical data and the proposed design for the second and final Phase 3 study were presented to the FDA and the European Medicines Agency (EMA). Concurrence has been achieved with the regulators on a single, globally harmonized Phase 3 study for licensure. Moving the final Phase 3 study forward is predicated on finalizing the above proposed investment. Phase 3 product candidate AR-320 Following a lengthy effort to resolve the product licensing dispute with MedImmune Limited (“MedImmune”, a subsidiary of AstraZeneca), a mutually satisfactory resolution has not been reached. The Company is currently exploring its legal options for loss recovery. Development status: AR-320 is being developed for the prevention of Ventilator Associated Pneumonia (VAP) in a pivotal Phase 3 clinical trial. The AR-320-003 Phase 3 clinical study was initiated in 2022, with 24 patients enrolled. The study was placed on voluntary hold at the time that the product license dispute with MedImmune arose, and is now expected to be discontinued. Company operations and financials The Company’s primary focus in the past year has been on business development discussions related to its clinical product candidates, on laboratory activities to support two NIH active grant awards and on one funded external collaboration related to the APEX platform technology. Operating expenses, including clinical trial and clinical supplies manufacturing have been substantially lowered while all clinical trials have either been completed or terminated. The Company has been working with its lead lender Streeterville Capital, LLC to service the loan. The Company’s near-term goals will be to successfully complete the business objectives described above and to become current on its SEC filings in the first half of 2025. About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is advancing multiple clinical stage monoclonal antibodies (mAbs) targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with current standard-of-care broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The Company’s mAb portfolio is complemented by a novel non-antibiotic small molecule anti-infective candidate mechanism being developed to treat lung infections in cystic fibrosis patients. The Company’s pipeline is highlighted below: Aridis' Pipeline AR-301 (VAP). AR-301 is a fully human IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin that has recently completed the first of two planned Phase 3 superiority clinical studies as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP).AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being evaluated in a Phase 3 clinical study as a preventative treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP.AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis (CF) patients. This program has successfully completed Phase 2a clinical development in CF patients.AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple protein epitopes on the SARS-CoV-2 virus. It is formulated for delivery via intramuscular injection or inhalation using a nebulizer.AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia (HAP) cases worldwide.AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV). For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/. [I haven’t reviewed the website, but you’ll want to be sure there are no inconsistencies with this release] Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the need for additional financing, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2022 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Contact:Rebecca EdwardsAdministratorAridis Pharmaceuticals, Inc.info@aridispharma.com408-385-1742 SOURCE Aridis Pharmaceuticals, Inc.

Phase 3Clinical ResultPhase 2Phase 1Acquisition

25 Jun 2024

·www.globenewswire.com

Aridis Provides Corporate Update

June 24, 2024 -- Aridis Pharmaceuticals, Inc. (OTC: ARDS) (“Aridis” or the “Company”), a biopharmaceutical company, today announced a corporate update on recent developments. The Company has been in sustained discussions with other pharmaceutical companies and investment firms on possible partnerships and investments on its clinical product candidates AR- 301, AR-320, AR-501, and the APEX platform technology. The principal goal for the discussions has been to build shareholder value by out-licensing or attracting capital investments to complete the final stages of product development. A summary of the status of the major programs is further highlighted below: The Company believes that the observed consistency of positive clinical efficacy trends and the magnitude of clinical response associated with AR-301 treatment observed in older patients in the first Phase 3 study underscore the need for its continued development. The discussions with potential partners to continue the development of AR-301 are expected to reach a definitive outcome in the 4th quarter. Development status: AR-301 is currently being evaluated for the adjunctive therapeutic treatment of Ventilator Associated Pneumonia (VAP). The first of two planned Phase 3 clinical trials saw significant reduction in patient enrollment that was brought about by the COVID-19 pandemic, resulting in an under-powered study. However, despite a small sample size, a positive efficacy trend in favor of AR-301 in VAP patients was observed (p=0.242 at day 21). Remarkably, in a prespecified subpopulation of adults 65 years and older, the efficacy signal was increased by approximately 300%, reaching statistical significance level (p=0.056 at day 21 and p=0.025 at day 28 post-treatment). Furthermore, AR-301 treated patients had a median reduction of length of stay in the intensive care unit (ICU) and hospital by 7 days and by 9 days in the over 65 subpopulation. The clinical data and the proposed design for the second and final Phase 3 study were presented to the FDA and the European Medicines Agency (EMA). Concurrence has been achieved with the regulators on a single, globally harmonized Phase 3 study for licensure. In the past year the Company has diligently explored paths toward a potential resolution of its product licensing dispute with MedImmune Limited (“MedImmune”, a subsidiary of AstraZeneca). The Company expects to settle on a definitive path forward in the next quarter. Development status: AR-320 is being developed for the prevention of Ventilator Acquired Pneumonia (VAP) in a pivotal Phase 3 clinical trial. The AR-320-003 Phase 3 clinical study was initiated in 2022, with 24 patients enrolled. The study was placed on voluntary hold at the time - the product license dispute with MedImmune arose and continues to be on hold while the Company continues to explore potential resolutions. The recent demonstration in Phase 2a that the study met its primary and secondary endpoints in cystic fibrosis (CF) patients has facilitated business development discussions with potential pharmaceutical partners The positive clinical trial data also facilitated the filing of non-dilutive grant funding support from governmental sources and non-governmental organizations (NGO). Development status: AR-501 is being developed as a therapeutic treatment for chronic bacterial lung infections in cystic fibrosis patients. A Phase 1 trial in healthy adults and a Phase 2a trial in cystic fibrosis patients were completed. The primary endpoint of safety was achieved in both studies, showing that AR-501 was well tolerated when administered as an inhaled dosage form over several weekly treatments. The pharmacokinetic data showed effective delivery of AR-501 into the lungs of CF patients and a fast clearance rate. The Company’s primary focus in the past year has been on business development discussions related to its clinical product candidates, on laboratory activities to support two NIH active grant awards and on one funded external collaboration related to the APEX platform technology. Operating expenses, including clinical trial and clinical supplies manufacturing have been significantly lowered while the AR-320-003 trial has been on hold. The Company has been working with its lead lender Streeterville Capital, LLC to service the loan via equity exchange agreements. The Company’s near-term goals will be to successfully complete the business objectives described above and to become current on its SEC filings in the coming quarter. Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is advancing multiple clinical stage monoclonal antibodies (mAbs) targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with current standard-of-care broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The Company’s mAb portfolio is complemented by a novel non-antibiotic small molecule anti-infective candidate mechanism being developed to treat lung infections in cystic fibrosis patients. The Company’s pipeline is highlighted below: AR-301 (VAP). AR-301 is a fully human IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin that has recently completed the first of two planned Phase 3 superiority clinical studies as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP). AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being evaluated in a Phase 3 clinical study as a preventative treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP. AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis (CF) patients. This program has successfully completed Phase 2a clinical development in CF patients. AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple protein epitopes on the SARS-CoV-2 virus. It is formulated for delivery via intramuscular injection or inhalation using a nebulizer. AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii. AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia (HAP) cases worldwide. AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV). The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

24 Jun 2024

·www.biospace.com

Aridis Provides Corporate Update - June 24, 2024

LOS GATOS, Calif., June 24, 2024 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (OTC: ARDS) (“Aridis” or the “Company”), a biopharmaceutical company, today announced a corporate update on recent developments. The Company has been in sustained discussions with other pharmaceutical companies and investment firms on possible partnerships and investments on its clinical product candidates AR- 301, AR-320, AR-501, and the APEX platform technology. The principal goal for the discussions has been to build shareholder value by out-licensing or attracting capital investments to complete the final stages of product development. A summary of the status of the major programs is further highlighted below: LeadproductcandidateAR-301 The Company believes that the observed consistency of positive clinical efficacy trends and the magnitude of clinical response associated with AR-301 treatment observed in older patients in the first Phase 3 study underscore the need for its continued development. The discussions with potential partners to continue the development of AR-301 are expected to reach a definitive outcome in the 4th quarter. Development status: AR-301 is currently being evaluated for the adjunctive therapeutic treatment of Ventilator Associated Pneumonia (VAP). The first of two planned Phase 3 clinical trials saw significant reduction in patient enrollment that was brought about by the COVID-19 pandemic, resulting in an under-powered study. However, despite a small sample size, a positive efficacy trend in favor of AR-301 in VAP patients was observed (p=0.242 at day 21). Remarkably, in a prespecified subpopulation of adults 65 years and older, the efficacy signal was increased by approximately 300%, reaching statistical significance level (p=0.056 at day 21 and p=0.025 at day 28 post-treatment). Furthermore, AR-301 treated patients had a median reduction of length of stay in the intensive care unit (ICU) and hospital by 7 days and by 9 days in the over 65 subpopulation. The clinical data and the proposed design for the second and final Phase 3 study were presented to the FDA and the European Medicines Agency (EMA). Concurrence has been achieved with the regulators on a single, globally harmonized Phase 3 study for licensure. Phase3productcandidateAR-320 In the past year the Company has diligently explored paths toward a potential resolution of its product licensing dispute with MedImmune Limited (“MedImmune”, a subsidiary of AstraZeneca). The Company expects to settle on a definitive path forward in the next quarter. Development status: AR-320 is being developed for the prevention of Ventilator Acquired Pneumonia (VAP) in a pivotal Phase 3 clinical trial. The AR-320-003 Phase 3 clinical study was initiated in 2022, with 24 patients enrolled. The study was placed on voluntary hold at the time - the product license dispute with MedImmune arose and continues to be on hold while the Company continues to explore potential resolutions. Phase2productcandidateAR-501 The recent demonstration in Phase 2a that the study met its primary and secondary endpoints in cystic fibrosis (CF) patients has facilitated business development discussions with potential pharmaceutical partners The positive clinical trial data also facilitated the filing of non-dilutive grant funding support from governmental sources and non-governmental organizations (NGO). Development status: AR-501 is being developed as a therapeutic treatment for chronic bacterial lung infections in cystic fibrosis patients. A Phase 1 trial in healthy adults and a Phase 2a trial in cystic fibrosis patients were completed. The primary endpoint of safety was achieved in both studies, showing that AR-501 was well tolerated when administered as an inhaled dosage form over several weekly treatments. The pharmacokinetic data showed effective delivery of AR-501 into the lungs of CF patients and a fast clearance rate. Companyoperationsandfinancials The Company’s primary focus in the past year has been on business development discussions related to its clinical product candidates, on laboratory activities to support two NIH active grant awards and on one funded external collaboration related to the APEX platform technology. Operating expenses, including clinical trial and clinical supplies manufacturing have been significantly lowered while the AR-320-003 trial has been on hold. The Company has been working with its lead lender Streeterville Capital, LLC to service the loan via equity exchange agreements. The Company’s near-term goals will be to successfully complete the business objectives described above and to become current on its SEC filings in the coming quarter. AboutAridisPharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is advancing multiple clinical stage monoclonal antibodies (mAbs) targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with current standard-of-care broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The Company’s mAb portfolio is complemented by a novel non-antibiotic small molecule anti-infective candidate mechanism being developed to treat lung infections in cystic fibrosis patients. The Company’s pipeline is highlighted below: Aridis' Pipeline AR-301 (VAP). AR-301 is a fully human IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin that has recently completed the first of two planned Phase 3 superiority clinical studies as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP). AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being evaluated in a Phase 3 clinical study as a preventative treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP. AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis (CF) patients. This program has successfully completed Phase 2a clinical development in CF patients. AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple protein epitopes on the SARS-CoV-2 virus. It is formulated for delivery via intramuscular injection or inhalation using a nebulizer. AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii. AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia (HAP) cases worldwide. AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV). For additional information on Aridis Pharmaceuticals, please visit . [I haven’t reviewed the website, but you’ll want to be sure there are no inconsistencies with this release] Forward-LookingStatements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the need for additional financing, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2022 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Contact: Rebecca Edwards Administrator Aridis Pharmaceuticals, Inc. info@aridispharma.com 408-385-1742 SOURCE Aridis Pharmaceuticals, Inc.

Phase 2Phase 3Clinical Result

100 Deals associated with Suvratoxumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11124	Suvratoxumab	-	DB15172

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia, Ventilator-Associated	Phase 3	Belgium	Aridis Pharmaceuticals, Inc.	02 Sep 2022
Pneumonia, Ventilator-Associated	Phase 3	France	Aridis Pharmaceuticals, Inc.	02 Sep 2022
Pneumonia, Ventilator-Associated	Phase 3	Greece	Aridis Pharmaceuticals, Inc.	02 Sep 2022
Pneumonia, Ventilator-Associated	Phase 3	Israel	Aridis Pharmaceuticals, Inc.	02 Sep 2022
Pneumonia, Ventilator-Associated	Phase 3	Netherlands	Aridis Pharmaceuticals, Inc.	02 Sep 2022
Pneumonia, Ventilator-Associated	Phase 3	Spain	Aridis Pharmaceuticals, Inc.	02 Sep 2022
Pneumonia, Staphylococcal	Phase 2	United States	MedImmune LLC	10 Oct 2014
Pneumonia, Staphylococcal	Phase 2	Belgium	MedImmune LLC	10 Oct 2014
Pneumonia, Staphylococcal	Phase 2	Czechia	MedImmune LLC	10 Oct 2014
Pneumonia, Staphylococcal	Phase 2	France	MedImmune LLC	10 Oct 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02296320 (SAATELLITE, Pubmed) Manual	Phase 2	Pneumonia, Ventilator-Associated	198	suvratoxumab	bxibldgtlf(pxaotnhaek) = vmodvlhvnx urxybsdeqe (xicjxgynuj ) View more	Positive	01 Sep 2021
				Placebo	bxibldgtlf(pxaotnhaek) = qxbsfistfh urxybsdeqe (xicjxgynuj ) View more
NCT02296320 (SAATELLITE, CTgov)	Phase 2	Pneumonia, Staphylococcal	213	Placebo (Placebo)	zxmqhtpbkd = zfawextkxw mioqppijbz (xiqzltczsm, fawgnhsedv - rziyjftoox) View more	-	25 Oct 2019
				MEDI4893 (MEDI4893 2000 mg)	zxmqhtpbkd = kwagynmyqw mioqppijbz (xiqzltczsm, afrdwdssmr - dcxhjtptcl) View more
NCT02296320 (Pubmed \| Antimicrob Agents Chemother)	Phase 1	-	213	MEDI4893 225 mg	bkpnspcxdd(qkvevubkyz) = nqrwuhxyhg hiwocoqdpx (ckciycmalc )	-	01 Jan 2017

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