AN2 Therapeutics, Inc. operates as a global health biopharmaceutical company. The firm focuses on modern biomedical and drug development to provide transformational medicines for patients suffering from infectious diseases. The company was founded by Eric Easom, George Harrison Talbot, Joseph S. Zakrzewski and Michael R.K. Alley and is headquartered in Menlo Park, CA.
Clinical Trials
8
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2017
Completed
6
75.0%
Suspended
1
12.5%
Terminated
1
12.5%
No approval data available
- AN2 Therapeutics expects to have three Phase 2 programs underway by the end of 2026, spanning polycythemia vera, M. abscessus lung disease, and chronic Chagas disease. - The Phase 2 EBO-PV-201 study of oral epetraborole in phlebotomy-dependent polycythemia vera will expand to U.S. and Australian sites, with enrollment anticipated to begin in Q4 2026. - Positive non-human primate efficacy and favorable Phase 1 data support planned Phase 2 initiation of AN2-502998 in chronic Chagas disease by year-end. - The company reported a net loss of $8.2 million for Q2 2026, with $79.9 million in cash projected to sustain operations into 2029.
- AN2 Therapeutics announced plans to advance oral epetraborole into a Phase 2 proof-of-concept study for adults with phlebotomy-dependent polycythemia vera, a blood cancer affecting approximately 155,000 people in the U.S. - The decision is supported by clinical evidence showing epetraborole consistently demonstrated early, controlled, sustained, and dose-dependent hematocrit reductions across multiple clinical populations including healthy volunteers and NTM lung disease patients. - The Phase 2 trial is expected to begin in the third quarter of 2026 in India, with potential data readouts as early as fourth quarter 2026 and throughout 2027. - Epetraborole operates through a potentially differentiated mechanism targeting globin synthesis rather than heme synthesis, offering red-cell selectivity while sparing white blood cells and platelets.
- AN2 Therapeutics received FDA clearance to proceed with a 90-patient investigator-initiated trial evaluating epetraborole in patients with Mycobacterium abscessus lung disease. - The multicenter, randomized, double-blind, placebo-controlled study will focus on early-stage, treatment-naïve patients and aims to address the significant unmet need for oral therapies. - Currently, no FDA-approved therapeutics exist for this difficult-to-treat chronic lung infection, with patients relying on complex, off-label intravenous drug regimens. - Patient enrollment is expected to begin in the first quarter of 2026, with the study led by NTM expert Dr. Kevin Winthrop across 10-15 U.S. sites.
- AN2 Therapeutics and DNDi announced a collaboration to advance clinical development of AN2-502998, an oral drug candidate with curative potential for chronic Chagas disease affecting 6-7 million people worldwide. - The boron-based benzoxaborole compound targets CPSF3 in T. cruzi parasites, utilizing the same mechanism as acoziborole which achieved ~95% cure rates in African sleeping sickness trials. - Phase 1 first-in-human studies are underway with completion expected in the second half of 2025, followed by Phase 2 proof-of-concept trials planned for 2026. - DNDi will provide extensive clinical trial networks across Latin America and Spain, leveraging their established Chagas Clinical Research Platform to accelerate global access to this potential breakthrough therapy.
- AN2 Therapeutics completed a 200-patient observational study in acute melioidosis, revealing a striking mortality rate of nearly 40% by Day 90 despite standard of care treatment. - The NIH-funded study was conducted across three sites in melioidosis-endemic regions and tracked patients for over 90 days, highlighting the urgent need for more effective treatments. - The findings will inform the design of AN2's upcoming Phase 2 proof-of-concept trial for epetraborole, with IND submission planned and trial initiation expected later this year. - An additional 25% of screened patients died within 3-4 days before definitive diagnosis could be confirmed, underscoring the critical importance of early detection.
- Aligos Therapeutics has appointed Kieron Wesson, PhD as Vice President, Head of Chemistry Manufacturing Controls (CMC), bringing over 20 years of pharmaceutical development experience to the company. - The appointment comes at a strategic time as Aligos prepares to begin its Phase 2 study of ALG-000184 in mid-2025 for liver and viral diseases. - Dr. Wesson previously led CMC operations at Kezar Life Sciences and AN2 Therapeutics, and supported the approval and commercial launches of Kerydin® and Eucrisa® at Anacor Pharmaceuticals. - The hire reinforces Aligos' commitment to advancing its pipeline of therapeutics targeting chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.
- AN2 Therapeutics has selected Quality of Life-Bronchiectasis (QOL-B) respiratory domain as the new primary efficacy endpoint for their Phase 3 EBO-301 trial in treatment-refractory MAC lung disease. - The company plans to accelerate data unblinding in Q2 2025, following promising Phase 2 results where epetraborole showed statistical superiority versus placebo in QOL-B measurements. - This strategic shift aligns with FDA's 2023 guidance emphasizing patient-reported outcomes as primary endpoints in NTM drug development trials.
- Phase 2 clinical trials of epetraborole demonstrated significant improvements in respiratory quality of life for patients with refractory MAC NTM lung disease, supporting advancement to Phase 3 studies. - JMP Securities analyst maintains Buy rating for AN2 Therapeutics with a $5.00 price target, citing the drug's potential as a novel oral treatment option and upcoming FDA discussions. - Strong insider buying activity over the past quarter reflects growing corporate confidence in AN2 Therapeutics' development program and market potential.
