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SOURCE Moleculin, LLC
Results Show MOL4249 Produced Improvements in Skin Lesions With No Evidence of Toxicity
HOUSTON, Sept. 30, 2013 /PRNewswire/ -- Moleculin, LLC, a clinical-stage pharmaceutical company focused on developing topical treatments for inflammatory and proliferative skin diseases, today announced positive results from a double-blind, randomized Phase 2a study with MOL4249, a novel compound in development for the treatment of psoriasis. In the study, MOL4249 was shown to be effective in the treatment of mild-to-moderate plaque psoriasis when compared to the vehicle, with no detectable side effects.
"Despite the many treatment options available today, psoriasis continues to be an underserved skin disease with need for improvements in both efficacy and long-term tolerability over available therapies," said Walter Klemp, Chairman and CEO of Moleculin. "The Phase 2 data for MOL4249 are very encouraging and support our plans for continued study in larger numbers of patients."
The double-blind, controlled, Phase 2a study involved 16 patients with mild-to-moderate plaque psoriasis. Of these, 10 patients were treated with a topical compound containing MOL4249, while 6 were treated with a control vehicle. Patients applied the treatment twice a day for 28 consecutive days. 50% of patients treated with MOL4249 showed a 50% or better improvement in lesions, versus 17% for the vehicle. In addition, 30% of MOL4249 patients demonstrated a 75% or better improvement in lesions, versus 17% for the vehicle.
Patients and physicians reported no adverse events in the study, suggesting the potential of a topical treatment for psoriasis that is safe for long-term use. MOL4249 is a first-in-class small molecule drug that works by directly inhibiting p-STAT3, a novel target that may contribute to many chronic skin diseases regardless of its activating pathway. Data suggest that this unique mechanism of action may significantly reduce the incidence of side effects, making this compound safe for long-term, chronic use.
Psoriasis is a chronic autoimmune skin disease that occurs when the immune system mistakenly speeds up the growth cycle of skin cells. It affects up to 7.5 million Americans and can be difficult to treat because of side effects such as atrophy, or thinning of the skin, with long-term use.
Plaque psoriasis is the most common form of the disease in which people develop itchy skin spots, red patches, and a silvery white buildup of dead skin cells most often appearing on the scalp, lower back, knees, and elbows.
According to a patient survey conducted in the U.S. between 2001 and 2008 by the National Psoriasis Foundation, 33% of patients with mild disease and 60% of patients with moderate-to-severe psoriasis reported that their disease significantly affects their everyday life.
Moleculin is a clinical-stage pharmaceutical company advancing a new therapeutic approach to inflammatory and proliferative skin diseases, including psoriasis, atopic dermatitis, actinic keratosis, and several skin cancers. The Company's topical compounds are based on the direct inhibition of activated STAT3 (p-STAT3), an important target in the fight against chronic skin diseases. MOL4249, the Company's lead product candidate, is currently being studied in psoriasis. Early clinical studies with this p-STAT3 inhibitor suggest improved efficacy and tolerability for the treatment of mild-to-moderate psoriasis. For more information, visit moleculin.com.
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