Aridis Pharmaceuticals, Inc. 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.