AN2-502998
- Indication
- Chagas Disease
- Stage
- phase1
- Event
- Phase 1
- Details
June 4, 2026: AN2 Therapeutics, Inc. (NASDAQ: ANTX) reported positive preclinical and Phase 1 results for its oral CPSF3 inhibitor AN2-502998 for chronic Chagas disease (Trypanosoma cruzi infection). In a 28-day efficacy study in macaques with naturally acquired, chronic T. cruzi infection, 100% of treated animals achieved parasite elimination at exposure levels the company says are attainable in humans; parasite clearance was durable through four months post-treatment. Parasitemia was assessed using an enhanced PCR method, and AN2-502998 was reported as well tolerated with no drug-related adverse events.
In a Phase 1 first-in-human study (NCT07024589) in healthy volunteers using single ascending doses followed by multiple ascending doses over 10 days, AN2-502998 was generally well tolerated with no dose-limiting toxicities, and plasma exposures at or above the NHP efficacy thresholds were achieved with characterized PK.
The company said it plans to initiate a Phase 2 proof-of-concept study late this year and noted potential eligibility for an FDA Tropical Disease Priority Review Voucher upon approval.
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