CORK, Ireland, December 13, 2017 /PRNewswire/ --
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.
"Enrolling the first patient into our first phase 2 clinical
trial is a milestone achievement for Hovione", said 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 2 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 2 study.
About Papulopustular Rosacea
Rosacea is a chronic inflammatory condition that primarily
affects facial skin and manifests in different sub-types.
Subtype 2 rosacea (papulopustular) consists of constant
erythema and transient inflammatory pustules and papules.
Rosacea affects more than 16 million people in the US and has
an overall incidence of nearly 10%. The market for treating this
disease is estimated at $1.1 billion
annually. Oral tetracyclines have been used successfully in
combating inflammatory diseases such as papulopustular 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. Topical
administration of minocycline in rosacea has the potential to
displace the standard of care oral tetracycline therapies because
it reduces systemic exposure, which is associated with serious
adverse events.
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.
About Hovione
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
cGMP-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. Please visit
http://www.hovione.com
Contact
Isabel Pina
Director of Corporate Communications
Tel.: 0035121-982-9362
ipina@hovione.com
SOURCE Hovione