CORK, Ireland, May 25, 2017 /PRNewswire/ --
Hovione today announced the launch of its first clinical trial.
Hovione will soon initiate recruitment for its Phase 1 clinical
trial of HY02, a proprietary minocycline sterile ointment to treat
a subset of ocular surface inflammation, generally manifesting on
the inner edge of the eyelids, leading to eye irritation and
sometimes more severe symptoms such as blurring of the vision
and/or irritation of the cornea. This first in human study is a
double-blinded, randomized trial, which will include three arms and
enroll approximately 36 subjects over the next few months. Hovione
expects topline results by the end of 2017.
Carla Vozone, Vice President of Product Development and
Licensing (PDL) at Hovione, expressed enthusiasm for Hovione's
first clinical study using a patent protected minocycline API and
formulation developed by Hovione. "Hovione has been a leader in
tetracycline manufacturing for over 30 years. It is rewarding to
take minocycline, known systemically for its anti-inflammatory and
antibacterial benefits, and apply it locally to the site of action
in these patients with significant disease. Moreover, we
believe that local delivery will increase exposure to the affected
area without the negative adverse events associated with oral
delivery."
Oral tetracyclines have been used extensively and effectively in
combating diseases with profound contributions of inflammatory
reactions such as papulo-pustular 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. Minocycline is believed to have a superior
anti-inflammatory effect due to its increased lipophilicity
compared to other tetracyclines. This led Hovione to begin testing
their novel ophthalmic product in this new indication.
"Ophthalmologists and Optometrists have respected the numerous
beneficial effects of tetracycline class agents upon the ocular
surface, the corneal epithelium and stroma, the Meibomian glands,
the lid margins, and the peri-ocular skin. Despite systemic side
effects, oral Doxycycline and Minocycline are commonly prescribed
for a wide variety ocular and cutaneous diseases," stated Dr.
John Sheppard, Clinical Investigator
for Hovione's Phase 1 trial. "Ancillary anti-collagenolytic,
anti-MMP9, anti-inflammatory, and lipolytic activities of this
antibiotic class have proven beneficial for literally millions of
patients. The prospect of an effective topical agent like
Minocycline is truly exciting, and will provide safer access to
this highly respected and understandably underutilized therapeutic
agent."
Hovione's minocycline sterile ointment is a proprietary
formulation of crystalline minocycline base and oil-based
excipients. Hovione has applied for and been granted issued patents
for both the API and the drug product. This granted patent
portfolio covers both the US and the EU, with other patent
applications expected to be granted, expanding the portfolio
throughout the world. With the current granted patents, Hovione has
exclusivity through 2033.
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 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.: +35121-982-9362
ipina@hovione.com