바이오스펙테이터

바이오스펙테이터 Seunghyun Chon 기자

Ahn-Gook Pharma said that AG-B1512 (alternative name: somatotropin receptor agonist), a long-acting human growth hormone, has been designated by the Korea Health Industry Development Institute (KHIDI), a government-affiliated institution, as one of the most promising medicines to spur development of new technologies in pharmaceutical sectors.

For the project, the KHIDI will dedicate 1.05 billion won for two years, from Ahn-Gook’s total investment of 1.76 billion won. The company plans to launch a phase I clinical trial in advanced countries in 2018.

AG-B1512 was originally developed by Aprilbio and rationally designed as a new long-acting recombinant protein drug that can sustain efficacy of existing protein therapeutics. Ahn-Gook has been collaborating with Aprilbio to advance development of AG-B1512 through clinical studies, since their agreement in 2015.

Pharmacokinetic and pharmacodynamic data from preclinical study revealed that AG-B151 injection resulted in a half-life 20- to 40-fold higher when compared to other growth hormone products. The level of IGF-1 (human insulin-like growth factor-1), a surrogate marker activated by growth hormones, has been maintained up to 20 days following a single dose.

Efficacy of AG-B151, even when given once or twice a month in clinical study, may be comparable to once-daily commercial growth hormones.

Ahn-Gook officials commented that “The selection of AG-B1512 is quite meaningful in that the KHIDI fully recognizes its novelty and competitiveness as a promising somatotropin biobetter”. Ahn-Gook officials added, “We will strive to become a global leader in the field of growth hormones through intensive R&D studies to produce more successful research outcomes.”