Vicept Therapeutics Announces Positive Clinical Study Results of V-101 for the Treatment of the Erythema of Rosacea
MALVERN, Pa., Aug. 5 /PRNewswire/ -- Vicept Therapeutics, Inc.,
a privately held specialty biopharmaceutical company, announced
positive results today from a pharmacodynamic and pharmacokinetic
clinical trial of the Company's lead product V-101, a topical cream
under investigation for the treatment of erythema in patients with
The double-blinded, placebo-controlled, crossover clinical trial
of 22 patients with rosacea was designed to evaluate the
bioavailability of V-101 and provide preliminary evidence of
efficacy as measured by improvement in moderate to severe erythema,
the bright redness of the skin associated with rosacea. V-101 had a
side effect profile similar to placebo and V-101's active
ingredient was not detectable in study participants' plasma, a
strong indication of the product's overall tolerability and safety
profile. Additionally, the study results were positive for all
endpoints, demonstrating a clinically and statistically significant
improvement in treating the erythema associated with rosacea.
"This important study demonstrated that V-101 has a good safety
profile and provides statistically significant evidence of
effectiveness in treating the erythema of rosacea," said Dr. Neal
Walker, president and chief executive officer of Vicept. "We look
forward to advancing our clinical program into Phase II and
continuing our efforts to develop this product for the 16 million
people in the United States who live with this common, chronic skin
condition every day."
"Rosacea is devastating to people who live with it and the
primary complaint is erythema, the red sunburn appearance that
accompanies the disease," said James Leyden, M.D., Professor
Emeritus, University of Pennsylvania and lead investigator. "To
date, there are no FDA approved treatments for this manifestation
of the disease and V-101 offers a novel approach that, if
successful, would address this unmet medical need."
Rosacea is a common, chronic condition of the skin that is
estimated to affect more than 16 million people in the United
States and more than 45 million people worldwide. The disorder
appears most commonly in fair-skinned individuals of northern,
eastern European or Celtic origin between 30 and 50 years of age,
and women are affected 2-3x more often than men. Rosacea typically
occurs in a central facial distribution (cheeks, nose, forehead,
and chin) and is most commonly associated with a history of
flushing or blushing (transient erythema), persistent facial
redness (nontransient erythema), papules and/or pustules which may
resemble acne, and facial telangiectasias (dilated blood vessels).
Each of these signs may be transient or persistent and may occur
individually or in combination.
Vicept Therapeutics, Inc. is a privately held specialty
pharmaceutical company with a mission to develop the first
effective topically applied therapy directed toward the erythema of
rosacea and other disorders characterized by redness and or
flushing of the skin. The company is also pursuing the development
of topical agents for the treatment and prevention of a number of
medical and cosmetic indications including bruising of the skin.
The company is based in Malvern, Pennsylvania and more information
can be found by visiting the company's website at
Source: Vicept Therapeutics, Inc.
CONTACT: Mike Beyer of Sam Brown, Inc., +1-773-463-4211,
firstname.lastname@example.org, for Vicept Therapeutics, Inc.
Web Site: http://www.vicepttx.com/
Posted: August 2010