The randomized, double-blinded, vehicle-controlled study completed in late 2008 enrolled 186 patients with acne and consisted of twice daily topical applications of ASC-J9 cream for 12 weeks to evaluate safety and ascertain preliminary efficacy.
It is reported that ASC-J9 demonstrated a clinical benefit in reducing inflammatory lesions compared to placebo at certain dosages and at multiple time points during the study, though the study was not powered for statistical significance.
AndroScience said that it will now focus on bolstering efficacy through a new formulation and intends on forming a co-development or licensing partnership for future clinical development and commercialization.
Through enhancing androgen receptor protein degradation, ASC-J9 represents the first topical agent directed at modulating the effect of androgens, through the androgen receptor, a key causative factor in the pathogenesis of acne, according to AndroScience.
Charles Shih, CEO of AndroScience, said: “We are extremely enthusiastic about the therapeutic potential of ASC-J9 and the remarkable safety profile exhibited by the drug. The 0.025% cream formulation dose of ASC-J9 delivered a therapeutic benefit comparable to levels seen with marketed acne drugs on inflammatory lesions, with no side effects, and we believe a higher dosage or improved formulation will translate to even greater efficacy in the treatment of acne.”