A Phase 2 Clinical Trial for the Treatment of Moderate to Severe Inflammatory Rosacea with its Proprietary Minocycline Topical Gel
Cork, Ireland, 25th of May 2017 – Hovione today announced the launch of its first clinical trial. Hovione will soon initiate recruitment for its Phase 1 clinical trial of HY02, 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. 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.
Carla Vozone, Vice President of Product Development and Licensing (PDL) at Hovione, expressed enthusiasm for Hovione’s first clinical study using a patent protected minocycline API and formulation developed by Hovione. “Hovione has been a leader in tetracycline manufacturing for over 30 years. It is rewarding to take minocycline, known systemically for its anti-inflammatory and antibacterial benefits, and apply it locally to the site of action in these patients with significant disease. Moreover, we believe that local delivery will increase exposure to the affected area without the negative adverse events associated with oral delivery.”
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.
“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,” stated Dr. John Sheppard, Clinical Investigator for Hovione’s Phase 1 trial. “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’s minocycline sterile ointment is a proprietary formulation of crystalline minocycline base and oil-based excipients. 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.
Hovione is an international company with over 57 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.