In a crowded rosacea topical market, Hovione is trialing a new topical antibiotic formulation – 1% vs. 3% minocycline gel. HY01 is said to be based on a “proprietary formulation of crystalline minocycline base and oil-based excipients.”
In the topical anti-papule and pustule market, this new formulation of Minocycline is up against the industry heavyweights Metrogel, Finacea and, Soolantra. Further competition exists from the in-development topical formulation of Minocycline from Foamix (FMX103).
A Phase 2 Clinical Trial for the Treatment of Moderate to Severe Inflammatory Rosacea with its Proprietary Minocycline Topical Gel
Cork, Ireland – Hovione announced today enrollment of the first patient in MARS (Minocycline Against Rosacea Study), a Phase 2 clinical study of topical minocycline (HY01) in moderate to severe papulopustular rosacea patients.
MARS is a multi-center, randomized, double-blind, parallel, vehicle-controlled study to evaluate the safety and efficacy of 1% and 3% topical minocycline gel. HY01 will be evaluated once-daily over a 12-week treatment period and the study will also include a cohort to determine minocycline systemic pharmacokinetic parameters.
The primary endpoint will include a change in inflammatory lesions from baseline. MARS will include 23 investigational sites across the United States and will enroll 249 subjects. The study is expected to be completed by the end of 2018.
About Minocycline Topical Gel
Hovione’s minocycline topical gel is a stable, proprietary formulation of crystalline minocycline base and oil-based excipients; in comparison, all minocycline formulations whether in clinical use or currently under clinical development, utilize minocycline hydrochloride as the active ingredient.
Hovione has secured patents for both the API and the drug product across the US and the EU with exclusivity through 2033. Minocycline is believed to have superior anti-inflammatory profile as compared to other tetracyclines.
The trial is listed at the official clinical trial site clinicaltrials.gov
Clinical Trial NCT03263273
To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular rosacea.
Estimated Enrollment: 249 Anticipated Study Start Date: October 30, 2017 Estimated Study Completion Date: September 28, 2018 Estimated Primary Completion Date: September 28, 2018