AN2 Therapeutics has reported topline data from the Phase Ib dose-ranging trial of its investigational, oral therapy epetraborole.
A once-a-day treatment, epetraborole is being developed for patients with rare, chronic and progressive non-tuberculous mycobacterial (NTM) lung disease.
The company will focus initially on treatment-refractory Mycobacterium avium complex (MAC) lung disease.
The placebo-controlled, double-blind trial analysed the safety, tolerability and pharmacokinetics (PK) of oral epetraborole doses ranging from 250mg to 1,000mg in healthy subjects for 28 days.
According to the findings, the oral therapy was demonstrated to be generally well-tolerated without any severe or serious adverse events.
Furthermore, PK was found to be generally linear and predictable which is in line with prior studies.
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AN2 Therapeutics chief medical officer Paul Eckburg said: “We believe the Phase Ib results further validate data from previous studies with epetraborole and demonstrate that it is well-tolerated when dosed for 28 days.
“These results, coupled with data available from our non-clinical efficacy and chronic toxicology studies completed earlier this year, provide us with additional confidence in dose selection for our pivotal Phase II/III trial, which we plan to initiate in the first half of this year in patients with treatment-refractory MAC lung disease.”
Epetraborole has obtained the US Food and Drug Administration Qualified Infectious Disease Product (QIDP), as well as Fast Track designations in treatment-refractory MAC lung disease.
AN2 Therapeutics president and CEO Eric Easom said: “There is only one approved therapy in the US for patients with pulmonary NTM, and patients and physicians need better options.”