Followers | 177 |
Posts | 24415 |
Boards Moderated | 12 |
Alias Born | 04/03/2002 |
Monday, June 14, 2021 9:57:43 AM
From ARDS:
Clinical Program Update
AR-301: AR-301 is being evaluated in a Phase 3 clinical study as an adjunctive treatment to standard of care antibiotics in S. aureus infected ventilator associated pneumonia (VAP) patients. Thus far, the pace of the trial has continued to be impacted by the protracted COVID-19 pandemic. The Phase 3 interim futility analysis from the ongoing pivotal trial is now expected to be reported in 2H 2021 and top line data by 1H 2022. It's important to note that COVID-19 patients on prolonged mechanical ventilation in the intensive care unit (ICU) are prone to secondary infections (also called 'superinfections') by opportunistic pathogens such as bacteria. Superinfection is a reported complication in COVID-19 patients, which exacerbates morbidity and the rate of mortality. The AR-301 Phase 3 study allows for the enrollment of patients with baseline characteristics which are inclusive of certain COVID-19 patients. While AR-301 is not an agent to treat SARS-CoV-2 virus itself, it can potentially reduce the morbidity associated with secondary S. aureus pneumonia, which is a coronavirus complication and a contributing cause of death in such patients.
The trial is expected to enroll 240 patients at approximately 160 clinical centers in 22 countries. Participating clinical centers that are activated continue to follow standard stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956.
AR-501: During the quarter, ARDS initiated the Phase 2a study to evaluate the safety, pharmacokinetic, and preliminary efficacy evaluation in cystic fibrosis (CF) patients. The Phase 2a is set to enroll 42 cystic fibrosis adult patients and is expected to complete enrollment by the end of 2021.
AR-501 is being developed in collaboration with the CF Foundation and has been granted Orphan Drug Designation (ODD), Fast Track and Qualified Infectious Disease Product (QIDP) designations by the FDA. In addition, the European Medicines Agency (EMA) granted ODD to AR-501. The original Phase 1/2a clinical trial was a randomized, double-blinded, placebo-controlled SAD and MAD trial investigating the safety and PK of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections. Details of the original Phase 1/2a clinical trial can be viewed on http://www.clinicaltrials.gov using identifier NCT03669614.
Recent ARDS News
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 01:02:49 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/16/2024 11:05:19 AM
- Aridis Pharmaceuticals Announces Adjournment of Annual Meeting of Stockholders until January 12, 2024 • GlobeNewswire Inc. • 12/15/2023 09:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/03/2023 09:00:31 PM
- Aridis Pharmaceuticals Announces Third Quarter 2023 Financial Results and Business Update • GlobeNewswire Inc. • 11/03/2023 08:15:00 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 11/03/2023 10:15:10 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 09/14/2023 01:47:15 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/07/2023 08:15:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/25/2023 08:05:18 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/04/2023 08:05:48 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/04/2023 08:05:48 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/03/2023 08:15:38 PM
- Aridis Pharmaceuticals Announces $2 Million Offering • GlobeNewswire Inc. • 08/02/2023 12:17:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/02/2023 04:15:14 AM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 07/21/2023 10:49:05 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/20/2023 09:18:38 PM
- Aridis Receives Agreement from the European Medicines Agency (EMA) on the Clinical Study Design and a Single Confirmatory Phase 3 Study of AR-301 • GlobeNewswire Inc. • 07/17/2023 08:05:00 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 07/17/2023 07:01:05 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 07/17/2023 11:36:32 AM
- Aridis’ AR-301 Monoclonal Antibody is Among the First Biologics to Receive FDA’s Qualified Infectious Diseases Product (QIDP) Designation • GlobeNewswire Inc. • 07/12/2023 12:00:00 PM
- Aridis Pharmaceuticals' AR-301 Eligible for Consideration under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) • GlobeNewswire Inc. • 06/20/2023 12:00:00 PM
- Aridis Pharmaceuticals Announces First Quarter 2023 Financial Results and Business Update • GlobeNewswire Inc. • 06/08/2023 08:05:00 PM
- Aridis Receives Agreement from the FDA on a Single Confirmatory Phase 3 Study of AR-301 and the Clinical Study Design • GlobeNewswire Inc. • 05/31/2023 12:00:00 PM
- Aridis Pharmaceuticals Receives Nasdaq Notice on Late Filing of its Form 10-Q • GlobeNewswire Inc. • 05/25/2023 08:05:00 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM