Altheos has dosed the first patient in a Phase 2a clinical trial of its investigational drug candidate ATS907, a Rho kinase (ROCK)-selective inhibitor used as a next-generation eye drop for minimising elevated intraocular pressure (IOP) in primary open angle glaucoma and ocular hypertension.
Licensed from Tokyo-based Asahi Kasei Pharma, ATS907 is one of a series of ROCK inhibitor compounds.
The first-in-human study is a randomised, controlled, investigator masked dose-ranging safety and efficacy trial conducted in subjects with primary open angle glaucoma and/or ocular hypertension.
The study utilises a two-stage adaptive design to assess a number of different doses of ATS907 ophthalmic formulation and to provide preliminary information on safety, tolerability and efficacy following 28 days of administration.
Altheos chief medical officer Barbara Wirostko said, "ATS907 was selected for development based on data demonstrating properties that were optimal for ocular administration. The drug shows excellent ocular surface penetration, and is rapidly converted into a more active form in the anterior chamber after topical dosing. This prodrug-like activity may enhance its therapeutic index."
The company anticipates beginning the second stage of the trial, designed to compare ATS907 and latanoprost, a prostaglandin analogue, soon after completion of the first stage.
Altheos has secured an additional $12.5m in its Series A financing to enable completion of a Phase 2 clinical programme of the glaucoma drug.
Altheos chief executive officer Henry Hsu said the expanded Series A round will allow the company to advance the lead candidate to Phase 3 trials.
Altheos is a biopharmaceutical company focused on the development of small-molecule drugs for the treatment of ocular diseases.