newsfilter
← Latest News
Business Wire·

AN2 Therapeutics Reports Positive Enabling Data Supporting Advancement of Oral AN2-502998 to Phase 2 Study for Chronic Chagas Disease

  • AN2 Therapeutics reported 100% elimination of Trypanosoma cruzi parasites in nonhuman primates after 28 days of AN2-502998 treatment with durable effects lasting four months post-treatment.
  • The Phase 1 First-In-Human study demonstrated a favorable safety profile for AN2-502998 with no dose-limiting toxicities observed at exposure levels consistent with nonhuman primate efficacy thresholds.
  • AN2-502998 is an oral CPSF3 inhibitor derived from a boron chemistry platform & is the first compound to show curative activity in nonhuman primates with naturally acquired chronic Chagas disease.
  • The treatment targets a global market of approximately 10 million people with chronic Chagas disease, including over 300,000 in the U.S., where no FDA-approved adult therapies currently exist.
  • Potential regulatory benefits include eligibility for an FDA Tropical Disease Priority Review Voucher upon approval due to the high unmet medical need for chronic Chagas disease treatments.
  • The company plans to initiate a Phase 2 proof-of-concept study late in 2026 in collaboration with the Drugs for Neglected Diseases initiative (DNDi).
  • AN2-502998 targets the same CPSF3 enzyme as acoziborole, which was recently approved by the EMA for human African trypanosomiasis.