AndroScience (ASC) and Taiwanese firm Orient Europharma (OEP) are partnering on the former’s ASC-J9®, a topical treatment for acne. Under the terms of the development and commercialization deal, OEP is responsible for expenses related to a Phase IIb multicenter trial in acne vulgaris. Scheduled to commence in September, the 180-patient, double-blinded, placebo-controlled study will be jointly conducted at clinical sites in Taiwan and the U.S.
OEP has exclusive commercial rights to ASC-J9 in Taiwan, Hong Kong, S. Korea, New Zealand, Australia, and other select markets served by OEP throughout Asia Pacific. ASC will support approval of the product in OEP-designated territories by providing new drug approval materials following successful regulatory submission of the product in the U.S. or Europe. ASC says that it has initiated licensing discussions with U.S.- and European-based companies for ASC-J9.
“Aligning with OEP allows access to the capital resources necessary to complete a critical milestone toward demonstrating ASC-J9 as a safe and efficacious acne treatment,” notes Charles Shih, Ph.D., president, CEO, and founder of ASC.
Developed as a cream formulation for use in both men and women, ASC-J9 is directed at modulating the effect of androgens through the androgen receptor (AR). Androgen’s association with increased acne development and the role of hormones as a trigger of sebum production, sebaceous growth, and differentiation are well known, ASC points out. Yet, a topical antiandrogen-based therapeutic has never been successfully developed.
ASC has discovered and developed a series of androgen receptor degradation (ARD) enhancer compounds. ARD enhancer exerts its function through reduction of AR and androgen function in sebaceous glands, which leads to the reduction of sebum secretion and the manifestation of acne.
In a previous Phase IIa trial, ASC-J9 in cream formulation lowered lesion counts in moderate-to-severe acne, with the highest dose group demonstrating the largest percent reductions from baseline at week 12 in inflammatory lesion count and total lesion count. No side effects have been noted in either Phase I or Phase IIa studies, ASC reports. The company states that it recently completed a new formulation of ASC-J9, which significantly enhances dermal penetration to improve efficacy.
Also in the ARD enhancer program is a clinical candidate for alopecia and preclinical programs in prostate cancer, liver cancer, and bladder cancer as well as spinal bulbar muscular atrophy. ASC also has a drug development program based on a family of small molecules that function as inhibitors of STAT 3 and 5 transcription factors. Initiated in 2009, preclinical proof of concept data has reportedly been obtained, and efforts are under way to develop lead drug candidates in the oncology setting for breast cancer, pancreatic cancer, colon cancer, glioblastoma, and other metastatic disease. Additional applications in treating immune-mediated disorders are also under development using STAT 3 and 5 inhibitor drug candidates.