AN2 Therapeutics Commences First-in-Human Clinical Trial of Oral AN2-502998 for Chagas Disease
- Preclinical studies in nonhuman primates naturally infected with T. cruzi have shown AN2-502998's curative potential in chronic Chagas disease
- No FDA approved treatment for adults with Chagas disease
- Phase 2 planning underway with recently announced DNDi collaboration; initiation expected in 2026, data in 2027
AN2 Therapeutics, Inc. (NASDAQ:ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, today announced that it has completed dosing the first single ascending dose cohort in its Phase 1 first-in-human clinical trial evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 in healthy volunteers. AN2-502998 is a potentially curative drug candidate for chronic Chagas disease. The Company expects to complete Phase 1 dosing by the end of 2025.
"This is an exciting milestone for our team and the community of patients suffering from chronic Chagas disease, caused by infection with the parasite T. cruzi. AN2-502998 is a promising potential oral cure for chronic Chagas disease, which affects an estimated 6-7 million people worldwide, including approximately 300,000 people in the U.S. and over 100,000 in Europe. Our studies in nonhuman primates that are naturally infected with T. cruzi have demonstrated AN2-502998's curative potential and provide a compelling translational rationale for its expected efficacy in humans. Chronic Chagas disease is often asymptomatic, so this significant unmet need has long been overlooked. We are committed to making a change," said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. "Our recently announced collaboration with the Drugs for Neglected Diseases initiative marks a pivotal step forward as we continue planning for a Phase 2 trial in parallel. Phase 2 potential proof-of-concept data is expected within our cash runway, advancing our commitment to bringing this much needed treatment to patients."
For more information about the Phase 1 study, please visit www.clinicaltrials.gov (NCT07024589).
About AN2-502998 in Chagas Disease
AN2-502998 is a boron-based small molecule therapeutic candidate from the benzoxaborole class, which has a broad therapeutic profile and includes two FDA-approved drugs (crisaborole and tavaborole). AN2-502998 is an orally active CPSF3 inhibitor in T. cruzi. CPSF3 is a key factor involved in messenger RNA processing and is the same target as the benzoxaborole drug candidate acoziborole, which showed ~95% cure rate after a single oral dose in a Phase 2/3 study for human African trypanosomiasis, a related disease caused by trypanosome parasites.
About Chagas Disease
Chagas disease (also known as American trypanosomiasis) is an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi). An estimated 6-7 million people worldwide are infected with the parasite T. cruzi, including approximately 300,000 people infected in the U.S. and over 100,000 in Europe. Left untreated, chronic Chagas infection is lifelong and silently damages the heart and digestive system, potentially resulting in heart failure, stroke, or sudden death. There are no FDA approved treatments for adults with Chagas disease.
About AN2 Therapeutics, Inc.
AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, melioidosis, and NTM lung disease caused by M. abscessus, along with programs focused on targets in oncology and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. For more information, please visit our website at www.an2therapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: AN2's plans about potential treatments for Chagas disease; the predictivity of non-human primate models for efficacy and safety of AN2-502998 in humans; the timing, design, execution, and outcome of a potential Phase 2 trial in Chagas; AN2-502998's potential to treat Chagas; the impact of Chagas and efficacy on current standard of care treatments; continuation of AN2's collaboration with DNDi through future trials. These statements are based on AN2's current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2's ability to conduct Phase 2 and future trials in Chagas; AN2-502998's safety profile based on the outcome of the Phase 1 FIH study and the possibility that safety findings could result in a decision not to advance to a Phase 2 trial; timely enrollment of patients in clinical trials; AN2's ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results, significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidates; the significant uncertainty associated with AN2's product candidates ever receiving any regulatory approvals; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading "Risk Factors" in AN2's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2's website at www.an2therapeutics.com and on the SEC's website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250812650698/en/
AN2 COMPANY CONTACT:
Lucy O. Day
Chief Financial Officer
[email protected]
INVESTOR AND MEDIA CONTACT:
Anne Bowdidge
[email protected]