AN2 Therapeutics

AN2 Therapeutics Shifts Phase 3 MAC Lung Disease Trial to Quality of Life Endpoint

3 months ago

• 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.

AN2 Therapeutics' Epetraborole Shows Promise in Phase 2 NTM Lung Disease Trial

4 months ago

• 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.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Spero Therapeutics Halts SPR720 Development After Phase 2a Trial Fails to Meet Primary Endpoint

7 months ago

• Spero Therapeutics suspends SPR720 development for NTM-PD after Phase 2a trial fails to demonstrate sufficient separation from placebo in interim analysis. • The Phase 2a trial showed antimicrobial activity but raised safety concerns, including reversible grade 3 hepatotoxicity at the 1,000mg dose. • Spero will restructure operations, reducing workforce by 39% to extend cash runway into mid-2026 and focus on tebipenem HBr and SPR206. • The company remains committed to advancing tebipenem HBr in its Phase 3 trial for cUTI and preparing for a Phase 2 trial for SPR206, pending funding.