AN2 Therapeutics Inc (ANTX) News & EventsANTXAN2 Therapeutics Inc

AN2 Therapeutics Appoints Cameron Trenor as Chief Medical Officer

AN2 Therapeutics announced the appointment of Cameron Trenor, M.D., as Chief Medical Officer. Most recently, Dr. Trenor served as Chief Medical Officer of Cellarity

AN2 Therapeutics to Launch Three Phase 2 Clinical Trials

"AN2 will have three Phase 2 programs underway by the end of this year, all of which have the potential to address major unmet needs. Our near-term focus is advancing start-up activities for the Phase 2 EBO-PV-201 study in polycythemia vera. We recently held a pre-IND meeting with the FDA and are expanding the Phase 2 study to include sites in the U.S. and Australia," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Enrollment is ongoing in an investigator-initiated Phase 2 study in M. abscessus lung disease. In our chronic Chagas program, compelling non-human primate efficacy data and a favorable clinical PK and safety profile from our Phase 1 study support planned initiation of a Phase 2 trial by year-end. We are also expanding our pipeline, having declared our first development candidate for solid tumors earlier this year and expecting to advance a second development candidate by the end of 2026. Collectively, these achievements underscore the potential of our boron chemistry platform to deliver differentiated therapies across multiple disease areas."

AN2 Therapeutics Announces Results of AN2-502998 for Chronic Chagas Disease

AN2 Therapeutics announced results from two studies evaluating the Company's oral CPSF3 inhibitor, AN2-502998, for the treatment of chronic Chagas disease caused by infection with the parasite T. cruzi. Key findings from the two studies: In NHPs with naturally acquired, chronic T. cruzi parasite infection, 28 days of AN2-502998 treatment resulted in 100% parasitic elimination at target exposures attainable in humans, through four months following the end of treatment. In the Phase 1 FIH study, AN2-502998 was generally well tolerated at exposure levels consistent with NHP efficacy thresholds, with no dose-limiting toxicities. "Results from these studies converge on the picture we were hoping to see: efficacy in NHPs at an exposure level achievable in humans, with an excellent safety profile as shown in the FIH study. Notably, parasites were eliminated after one month of treatment in NHPs with the same naturally acquired, chronic infection that we see in humans," said Eric Easom, CEO "Together, these data support our goal of making AN2-502998 the first FDA-approved therapy for chronic Chagas disease in adults. We believe an oral therapy capable of delivering high rates of parasitic cure after just one month of treatment could enable large-scale test-and-treat campaigns against this often lethal disease, which affects over 300,000 people in the U.S. and approximately 10 million globally. We look forward to initiating a Phase 2 proof-of-concept study late this year." The NHP efficacy study evaluated AN2-502998 administered for 28 days in macaques with naturally-acquired, chronic T. cruzi infection, contracted via triatomine vectors in their natural habitats, the same vector that transmits the parasite to humans. The Chagas disease vector is increasingly prevalent across the southern half of the U.S. The Company believes that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease. 100% of treated animals achieved parasite elimination at target exposures attainable in humans. Elimination of parasitemia in treated animals was durable and maintained through four months following the end of treatment. Parasitemia was evaluated using an enhanced PCR method with improved sensitivity and robustness. AN2-502998 was well tolerated with no drug-related adverse events. AN2-502998 is the only compound to have demonstrated curative activity in NHPs with long-term, naturally acquired T. cruzi infection. The Phase 1 FIH study evaluated single ascending oral doses of AN2-502998 and then multiple ascending doses administered over 10 days in healthy adult volunteers: AN2-502998 was generally well tolerated with no dose-limiting toxicities. Human PK was well characterized; plasma exposures at or above NHP efficacy thresholds were achieved.