Cutanea Announces Promising Results In Rosacea Trial With Omiganan

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Cutanea Life Sciences announced positive results from its completed Phase II clinical trial of Omiganan.

The trial compared Omiganan 2.5% and 1% topical gel to vehicle in subjects with papulopustular rosacea. Study results demonstrated that the formulation was safe and well-tolerated at all doses tested. Among the once-daily treatment arms, a dose-dependent response was observed in both lesion reductions and Treatment Success, as defined by Investigator Global Assessment (IGA) scores. After nine weeks of treatment, once-daily (QD) Omiganan 2.5% gel showed superior lesion count reductions and Treatment Success, compared to 1% Omiganan QD and vehicle. Omiganan provided greater improvements compared to vehicle among patients with a more severe condition at Baseline (more numerous inflammatory lesions). Lesion counts continued to drop at all evaluations over the duration of the study, indicating that further improvements may be expected with a duration of treatment exceeding nine weeks. Twice daily (BID) application of 2.5% Omiganan did not demonstrate substantial improvement in lesion reduction or the number of patients reaching Treatment Success compared to once daily application. Based on the results from this study, Cutanea has selected a once-daily dose of Omiganan 2.5% for further development for the treatment of papulopustular rosacea.

Dr. Guy Webster, Founding and Current President of the American Acne & Rosacea Society and Clinical Professor of Dermatology at Jefferson Medical College stated, "Topical Omiganan is a novel approach, actually the first in a new class of dermatologic drugs, for the treatment of rosacea. Initial results are promising and I look forward to a more precise estimation of the effectiveness of the drug in the larger Phase III program."

The objective of this exploratory Phase II study was to find the optimal dose and regimen of Omiganan for further study as a treatment for rosacea. The trial enrolled 240 patients with papulopustular rosacea and Investigator Global Assessment (IGA) scores of grade 3 or 4 (moderate to severe disease). Patients were randomized into one of five treatment groups in a 2:2:2:1:1 ratio: Omiganan 1% QD, Omiganan 2.5% QD, Omiganan 2.5% twice-daily (BID), Vehicle QD, or Vehicle BID. During the total nine-week treatment period, safety and efficacy assessments were performed at weeks one, three, six, and nine.

The primary efficacy endpoint was mean percent reduction in the number of inflammatory lesions from Baseline to Week 9. Patients receiving once-daily Omiganan 2.5% showed a mean 31% reduction in the number of inflammatory facial lesions compared to a 14% reduction in patients receiving once-daily vehicle. And, among rosacea patients with 18 or more lesions at Baseline, the mean reduction for once-daily Omiganan 2.5% was 40%, compared to an 11% lesion increase in the once-daily vehicle group.

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Secondary endpoints included the absolute change from Baseline in the number of inflammatory lesions at Week nine and at each interim visit, the percent change in number of inflammatory lesions at interim visits, the absolute change from Baseline in IGA score and other signs and symptoms of rosacea at Week nine and each interim visit, and Treatment Success at Week nine and each interim visit.

Although a statistically significant difference between active and vehicle was not achieved for the primary endpoint, this study demonstrated that in both the intent-to-treat and the per protocol populations, Omiganan 2.5% QD was statistically significantly better than vehicle QD at Week nine in the absolute change of inflammatory lesions (p=0.041 for intent-to-treat, and p=0.012 for per protocol populations). While in this exploratory study this endpoint was identified as a secondary end point, FDA currently requires the absolute change (rather than percent change) in the number of inflammatory lesions as one of the co-primary endpoints, along with Treatment Success, for demonstrating efficacy in a Phase III trial in rosacea.

"Based on these encouraging results, we have selected once-daily Omiganan 2.5% for further study in rosacea, which is a critical step towards potential commercialization, either directly or in collaboration with a partner," commented Robert J. Bitterman, President and CEO of Cutanea.

Rosacea is a chronic dermatologic disorder with no current cure and a poorly understood etiology that afflicts an estimated 14 million Americans. Symptoms primarily manifest on the facial skin and include facial flushing, central facial inflammatory lesions, and facial erythema. According to surveys conducted by the National Rosacea Society (NRS), nearly 70% of rosacea patients said the disorder had lowered their self-confidence and self-esteem; 41% reported it had caused them to avoid public contact or cancel social engagements; and nearly 30% claimed to have missed work due to rosacea. Of these rosacea patients surveyed by the NRS that sought medical treatment, over 70 percent reported an improvement in their emotional and social well-being.

Typical onset of rosacea occurs between 30 and 50 years of age and is more prevalent in women than men. Clearing up the initial outbreak is only the beginning, as rosacea is characterized by periods of relapses and remissions. Relapse episodes can be spurred by sun exposure, stress, hot or cold weather, alcohol, spicy foods, exercise, and certain skin care products and medications.

Absent a cure for rosacea, treatment is aimed at alleviating the disorder's symptoms. Topical or oral medications are generally prescribed for mild to moderate papulopustular Rosacea, while oral medications are prescribed for severe disease. Current oral antibiotic therapies may alleviate symptoms of rosacea, but may present an issue with undesirable side effects). While there are other topical products currently available on the market, there is an opportunity to improve the existing irritation profile for these treatments.

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