SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Altheos, Inc., announced today the dosing of the first patient in a Phase 2a clinical trial of its lead investigational candidate, ATS907, a Rho kinase (ROCK)-selective inhibitor in development as a next-generation eye drop for the reduction of elevated intraocular pressure (IOP) in primary open angle glaucoma and ocular hypertension. ATS907 is one of a series of ROCK inhibitor compounds licensed from Asahi Kasei Pharma. Altheos also announced the company raised an additional $12.5M in its Series A financing, bringing the total to $32.5M. The round, which will be tranched as the company reaches specified milestones, was provided by existing investors Bay City Capital, Novo A/S, Canaan Partners, and additional investors.
The first-in-human study is a randomized, controlled, investigator masked, dose-ranging, safety and efficacy study in subjects with primary open angle glaucoma and/or ocular hypertension. The study uses a two-stage adaptive design and is intended to evaluate a number of different doses of ATS907 ophthalmic formulation and to provide preliminary information on safety, tolerability and efficacy (reduction in intraocular pressure) following 28 days of administration. Altheos expects to initiate the second stage of this trial, a comparison of ATS907 and latanoprost (a prostaglandin analogue), closely following completion of the first stage.
“Ophthalmologists have indicated that there is a strong need for new treatment options in glaucoma. A ROCK inhibitor, which works through a mechanism of action unlike any drug currently available, is an exciting option,” said Barbara Wirostko, MD, Chief Medical Officer of Altheos and a glaucoma specialist. “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 expanded Series A round will enable completion of a robust Phase 2 clinical program. “The increase of our Series A round allows us the opportunity to advance our lead candidate to phase 3 trials. We are fortunate to have a highly committed group of investors and an experienced ocular drug development team,” said Henry Hsu, MD, CEO of Altheos, Inc.
About Rho Kinase Inhibitors for Glaucoma
Glaucoma is the second leading cause of blindness in the United States. Current treatments are directed toward lowering intraocular pressure (IOP) to reduce the risk of vision loss. Many patients require multiple drugs to help control IOP.
Research in the last decade has identified Rho kinase (ROCK) as an important mediator of aqueous humor outflow through the trabecular meshwork, or “conventional” outflow pathway. A decrease in fluid outflow via this pathway results in an increase in IOP. No drugs on the market target this specific pathway. In animal models, ROCK inhibitors have been shown to reduce cellular “stiffness” and enhance outflow through the trabecular meshwork, thereby reducing IOP. Preclinical data also suggests that inhibition of ROCK may offer neuroprotective benefits and may improve perfusion to the optic nerve, as well as having anti-inflammatory effects. An important goal for next-generation glaucoma drugs is to enhance efficacy with a minimum of tolerability issues. ATS907 was developed with the objective of providing a wider therapeutic index.
About Altheos, Inc.
Altheos, Inc., is a biopharmaceutical company focused on development of a new generation of promising, novel, small-molecule drugs for the treatment of ocular diseases. In 2010, the company obtained a worldwide license (outside of Japan and Korea) to a series of highly active compounds developed specifically for the treatment of ocular diseases, in particular glaucoma, from Tokyo-based Asahi Kasei Pharma, a pioneer in the field of ROCK inhibitors. Altheos is chaired by Les Kaplan, PhD, formerly President, Research and Development, at Allergan.