AN2 Therapeutics said it will shut down a late-phase study of its lead candidate in bacterial lung disease and then go through a company overhaul.
The placebo-controlled Phase 2/3 trial was testing the biotech’s bacterial leucyl-tRNA synthetase inhibitor, dubbed epetraborole, added to a background regimen in treatment-refractory Mycobacterium avium complex (MAC) lung disease.
The treatment arm met a Phase 2 primary endpoint of achieving a higher clinical response rate compared with placebo (p=0.19), as measured by a patient-reported outcome tool. But results in the key secondary endpoint of sputum culture conversion at six months were similar between treatment (13.2%) and placebo (10%) arms (p=0.64).
AN2 shares $ANTX were down 44% premarket Friday to $1.69.
The Menlo Park, CA-based company thus decided to discontinue the Phase 2/3 study based on the topline data. The biotech had already paused enrollment in the Phase 3 portion in February after blinded aggregate data suggested poor efficacy. Eighty patients had been enrolled in the Phase 2 part and 97 in the Phase 3 portion, according to a Thursday release.
Eric EasomAN2 said it will analyze results further before deciding whether to advance epetraborole in other forms of Nontuberculous mycobacteria lung disease.
In the meantime, “we plan to embark on a strategic restructuring and expect to extend our cash runway through 2027,” CEO Eric Easom said in the release. AN2 had $118.1 million in cash, equivalents and investments as of the end of March, according to its first-quarter earnings release.
As part of the restructuring, AN2 plans to axe half of its workforce, according to an SEC filing Wednesday. The company had 41 staffers as of the end of February.
The company’s next most advanced program is a preclinical candidate for Chagas disease, named AN2-502998, with plans to start a Phase 1 trial in the future.
Editor’s note: This article was updated to add further detail to the company overhaul, which is also reflected in the headline.