Hovione – Topical Minocycline Gel starts Phase 3 testing

Promoted as being safer than systemic antibiotics, a 3% formulation of topical minocycline gel has passed Phase 2 clinical trials and is readying to commence Phase 3 trials. The owners of the product, currently named HY-01 – Hovione are promoting their in-development topical as more moisturising than other comparable topicals, and less likely to induce unwanted side effects due to its application only to affected areas.

There are currently few antibiotic based topicals for the treatment of rosacea. Common topical for rosacea are based on non-antibiotic actives – for example: metronidazole, ivermectin, and azelaic acid. If proven, HY-01 may offer another option for rosacea sufferers for whom systemic antibiotics are not an option.

Hovione Announces Successful End-of-phase 2 Meeting With the FDA and Outlines Phase 3 Program for Minocycline Topical Gel

CORK, Ireland, Sept. 20, 2019 /PRNewswire/ — Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea. At a recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Hovione received guidance for the design and clinical endpoints for HY01, topical minocycline gel 3%.

Assuming replication of the clinically significant improvements in subjects with moderate to severe papulopustular rosacea observed in Phase 2, Minocycline Topical Gel may offer a safer alternative to modified-release doxycycline, which is the only tetracycline approved for the treatment of inflammatory lesions of rosacea. If approved, 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.

Hovione’s topical minocycline uses a novel proprietary excipient that reduces Trans-Epidermal Water Loss (TEWL) and provides a moisturizing, skin-barrier effect, potentially conferring relief to dry cracked skin of some rosacea patients.  Minocycline is proven to have a potent anti-inflammatory effect, potentially superior to other tetracyclines. 

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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