Hovione to initiate HY02 Phase 1 Clinical Trial

Hovione announced that it will soon initiate recruitment for its Phase 1 clinical trial of HY02. This first in human study is a double-blinded, randomized trial, which will include three arms and enroll approximately 36 subjects over the next few months.  Hovione expects topline results by the end of 2017.

HY02 is a proprietary minocycline sterile ointment to treat a subset of ocular surface inflammation, generally manifesting on the inner edge of the eyelids, leading to eye irritation and sometimes more severe symptoms such as blurring of the vision and/or irritation of the cornea.

Oral tetracyclines have been used extensively and effectively in combating diseases with profound contributions of inflammatory reactions such as papulo-pustular acne or rosacea. Tetracyclines’ non-antimicrobial bioactivity is known to be associated with the drug’s ability to inhibit Matrix Metalloproteinases (MMPs), specifically MMP-9. Minocycline is believed to have a superior anti-inflammatory effect due to its increased lipophilicity compared to other tetracyclines.  This led Hovione to begin testing their novel ophthalmic product in this new indication.

Clinical Investigator for Hovione’s Phase 1 trial, Dr. John Sheppard said that Ophthalmologists and Optometrists have respected the numerous beneficial effects of tetracycline class agents upon the ocular surface, the corneal epithelium and stroma, the Meibomian glands, the lid margins, and the peri-ocular skin.  Despite systemic side effects, oral Doxycycline and Minocycline are commonly prescribed for a wide variety ocular and cutaneous diseases. Ancillary anti-collagenolytic, anti-MMP9, anti-inflammatory, and lipolytic activities of this antibiotic class have proven beneficial for literally millions of patients.  The prospect of an effective topical agent like Minocycline is truly exciting, and will provide safer access to this highly respected and understandably underutilized therapeutic agent.

Hovione has applied for and been granted issued patents for both the API and the drug product.  This granted patent portfolio covers both the US and the EU, with other patent applications expected to be granted, expanding the portfolio throughout the world.  With the current granted patents, Hovione has exclusivity through 2033.