AN2 Therapeutics and DNDi Partner to Develop New Oral Treatment for Chronic Chagas Disease

AN2 Therapeutics, Inc., based in MENLO PARK, Calif., and the Drugs for Neglected Diseases initiative (DNDi) in Geneva have announced a partnership to advance the clinical development of AN2-502998, AN2's oral drug candidate for treating chronic Chagas disease. Chagas disease is a serious illness caused by the Trypanosoma cruzi parasite, impacting 6 to 7 million individuals globally, including around 300,000 in the United States. The parasite can invade various tissues such as the heart and gastrointestinal tract, leading to lasting damage. Although patients may be asymptomatic for years, about 30% of those with chronic T. cruzi infection develop significant health issues, including heart failure and digestive system complications. Given the progressive nature of the disease, timely diagnosis and treatment are crucial.

Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics, emphasized that the collaboration leverages DNDi's expertise in conducting Chagas disease clinical trials. This partnership is designed to optimize resources and expedite access to a potentially groundbreaking treatment across different regions, while allowing AN2 to focus on other promising pipeline projects. Easom also highlighted the involvement of Professor Rick Tarleton from the University of Georgia, underscoring the collaboration's potential to align global health impact with value creation for patients.

DNDi has played a significant role in Chagas disease research, establishing a network of clinical trial sites in Latin America and Spain, and creating the Chagas Clinical Research Platform in 2009 to advance research through collaborations. Dr. Laurent Fraisse, R&D Director at DNDi, stated that DNDi is dedicated to accelerating the development of promising candidates like AN2-502998, with whom the organization has a longstanding collaboration. This drug is part of the benzoxaborole class and shares a mechanism of action with acoziborole, a drug candidate showing high efficacy against African sleeping sickness.

Dr. María Jesús Pinazo, Head of Chagas disease at DNDi, noted that the collaboration with AN2 supports DNDi's broader efforts to develop novel treatments for Chagas disease. The initiative aims to create an oral, age-adapted, and shorter-course treatment that is safer and more effective than current options. DNDi is also investing in biomarker research and implementation studies to ensure that effective diagnostics and treatments reach those in need.

AN2-502998 is a boron-based small molecule therapeutic targeting the CPSF3 factor, which is critical in mRNA processing in T. cruzi. The drug's target is the same as acoziborole, which has shown a 95% cure rate in treating human African trypanosomiasis. AN2 Therapeutics is currently preparing for a Phase 1 clinical trial for AN2-502998, aiming for completion by late 2025, with plans to initiate a Phase 2 proof-of-concept study in 2026.

Chagas disease, also referred to as American trypanosomiasis, poses a significant health threat, particularly in Latin America, but also affects individuals in the United States and Europe. Without treatment, the infection can result in severe complications, including heart failure and sudden death. Currently, there are no FDA-approved treatments for adults with Chagas disease, underscoring the importance of ongoing research and development efforts.

The Drugs for Neglected Diseases initiative (DNDi) is a non-profit organization focused on developing and delivering treatments for neglected diseases. Since its inception in 2003, DNDi has collaborated with various entities to provide new treatments for numerous diseases, saving millions of lives. AN2 Therapeutics, Inc. is dedicated to developing small molecule therapeutics from its boron chemistry platform, targeting diseases such as Chagas, melioidosis, and NTM lung disease.