San Diego, CA. - March 6, 2009, AndroScience Corporation (ASCTM), a developmental stage pharmaceutical company announced results of a Phase 2a dose-ranging study of their lead clinical compound for the treatment of acne. 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.
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. ASC 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 (male hormones), through the androgen receptor, a key causative factor in the pathogenesis of acne.
Charles Shih, Ph.D., Chief Executive Officer of AndroScience Corporation, 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."
ASC-J9® is a small molecule with a novel mechanism of action, which selectively enhances androgen receptor degradation (ARD) to reduce androgen activity. ARD enhancers act on a key cause of acne, the androgen activation system, through reducing high levels of androgen receptor present in the sebaceous gland to lower sebum secretion, a fundamentally different approach from all other current acne treatments. ASC-J9® cream is topically administered and exhibits low systemic absorption, limiting systemic side effect risks and allowing for the treatment of both males and females.
Founded in 2000, AndroScience Corporation is developing novel small molecules targeting the androgen receptor (AR). The company has innovated a pipeline of drug candidates for androgen-related disorders with an initial clinical focus on dermatological indications and preclinical programs for systemic applications. The Company’s patented family of compounds is synthetically derived and enhances androgen receptor protein degradation via a novel mechanism of action, forming a new class of therapeutic compounds known as Androgen Receptor Degradation Enhancers (ARD Enhancers).
Representing considerable unmet medical needs for which current treatment modalities underperform or possess untoward side effects, a diverse range of androgen-related diseases exist that are ideal therapeutic indications for an ARD enhancer-based drug. The therapeutic indications AndroScience is currently pursuing include acne, androgenetic alopecia (AGA or male pattern baldness), and wound healing using topical based formulations and prostate cancer, benign prostatic hyperplasia, and spinal bulbar muscular atrophy (or Kennedy’s Disease – a neuron motor disease caused by AR mutation) utilizing systemic based approaches. Since finalizing proof of concept work on ARD enhancers and selecting ASC-J9® as the lead product candidate, ASC developmental achievements have included completing a Phase IIa clinical trial in acne in 2008. A Phase IIa trial in alopecia is scheduled for initiation in late 2009 following completion of final toxicology studies. Oral formulations are currently under development for Kennedy’s Disease and other oncology indications.
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From AndroScience Corporation
AndroScience Corporation Announces Phase 2a Study Results on ASC-J9® for the Treatment of Acne
Posted in: News & Events
By Press release
Mar 6, 2009 - 10:13:13 AM
Mar 6, 2009 - 10:13:13 AM
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