Results of ASC-J9-202 Phase 2B Clinical Study

Posted in: News & Events
Mar 22, 2013 - 5:26:31 PM

Results of ASC-J9-202, A Phase 2B Acne Clinical Study

AndroScience Corporation announces compelling (successful) results of a pivotal clinical trial investigating ASC-J9, the first of a novel class of compounds targeting androgen function for the topical treatment of acne vulgaris in men and women.

The successfully completed multi-center, double-blind, vehicle controlled, Phase 2B study sought to determine if two different doses of the dermally applied acne cream ASC-J9 treatment are more efficacious and safe at reducing facial acne versus a control treatment without active ingredient.  Approximately 180 male and female patients 12 years and older with moderate to severe facial acne vulgaris were randomized to either 0.025% or 0.1% facial cream (ASC-J9) or vehicle control cream (with 60 subjects per group).

Patients applied study medication twice daily on the face for 12 weeks. Safety was monitored throughout study duration and efficacy assessed by facial lesion counts and the investigator global assessment (IGA Score) of acne severity at baseline and at weeks 2, 4, 8, and 12. 

Based on primary and secondary efficacy assessments, results of the ASC-J9 Phase 2B study revealed a positive treatment response throughout the 12 weeks study. Reductions in all acne lesion counts were reported at weeks 2, 4, 8, and 12. Total, inflammatory, and non-inflammatory lesion counts, including the IGA success rate to indicate a clear clinical benefit of ASC-J9 treatment in alleviating moderate to severe acne. Both doses of ASC-J9 exhibited a remarkably safe drug profile, with no drug related systemic or dermal adverse event noted during the study.

AndroScience Corporation CEO, Charles Shih, PhD stated, “ We are extremely excited to have obtained the results reflected in our Phase 2B acne clinical study. It was rewarding to see such a high magnitude of improvement in acne severity in patients enduring this disconcerting condition. Furthermore, important efficacy assessments, including various time points at weeks throughout the study, the IGA score outcomes, and various important demographic group analysis indicated major lesion count reductions.”  Most importantly this new treatment would be the first topical drug that targets on androgen, i.e., one of the major causes of acne vulgaris, and is suitable for both male and female patients.  

In the last two decades, the acne market has encountered little innovation outside of new formulations or combinations in the therapeutic class of retinoids, antibiotics, or astringents; with a topically applicable anti-androgen, such as ASC-J9, representing a disruptive technology to benefit acne patients should have significant market penetration potential.  AndroScience now seeks to leverage positive results from this clinical study to engage prospective licensing partners for further development of ASC-J9 acne cream towards commercialization.

The development of this project was supported, in part, by the awarded NIH/NIAMS grants R43 AR051610 and R44 AR051610. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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