Hovione outlines Phase 3 Programme for Minocycline Topical Gel upon successful End-of-phase 2 meeting with FDA
23 September 2019 -

Drug product development company Hovione on Friday provided an update of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development programme for treating moderate to severe inflammatory rosacea, a chronic facial skin disease .

Following a recent End-of-Phase 2 meeting with the US Food and Drug Administration (FDA), the company received guidance for the design and clinical endpoints for HY01, topical minocycline gel 3%, which uses a proprietary, crystalline form of the drug as minocycline base, conferring differentiated properties of potentially lower skin irritability as compared to its generic alternative.

Based on the review of the company's Phase 2 clinical trial in 270 subjects across three treatment arms (HY01 Gel, 1%, HY01 Gel, 3%, and vehicle), the FDA has supported advancement to Phase 3.

The two, US based, pivotal Phase 3 studies will enroll 750 subjects each, with the primary endpoints of absolute reduction in inflammatory lesions at week 12 compared to baseline and the achievement of "clear" or "almost clear" and a two grade reduction on the Investigator Global Assessment, by fourth quarter of 2019, aiming at filing the NDA during 2021.

Upon approval, Minocycline Topical Gel will provide an important alternative treatment option targeted to the site of action and as thus avoiding the systemic side effects of oral doxycycline. The company has secured patents for both the drug substance and the drug product globally with exclusivity through 2033.