International contract development and manufacturing organisation (CDMO), Hovione has announced the enrolment of the first patient in the Phase II clinical trial of its topical minocycline (HY01) in moderate to severe papulopustular rosacea patients.
Patient recruitment
The MARS (Minocycline Against Rosacea Study) trial will evaluate the safety and efficacy of 1% and 3% topical minocycline gel as a once-daily treatment over a 12-week period. The study will be performed at multiple centres and will also include a cohort to determine minocycline systemic pharmacokinetic parameters.
A change in inflammatory lesions from baseline will be the primary endpoint of the study, which will enrol 249 patients in total. It is anticipated that the study will be completed by the end of 2018.
“Enrolling the first patient into our first Phase II clinical trial is a milestone achievement for Hovione,” explained Carla Vozone, vice president of Product Development and Licensing (PDL). “Hovione has been a leader in tetracycline manufacture for over 40 years. The leap into developing a new, patented formulation of minocycline, and taking it into a Phase II clinical study is a significant step towards the PDL business unit’s mission of developing innovative drugs that bring value to patients and our licensing partners.”
HY01 uses a patent protected minocycline base, which exhibits properties that have the potential of improving safety and efficacy of minocycline administration. Hovione plans to out-license HY01 at the end of the Phase II study.