Policy & Regulation
Asieris Pharmaceuticals receives Australian regulatory authority approval for APL-1501 Phase I clinical trial
29 October 2020 -

Asieris Pharmaceuticals, a China-based biotech company, has received approval for its Phase I clinical trial of APL-1501 from the Australian regulatory authorities, it was reported on Wednesday.

The aim of this Phase I study is to assess APL-1501's safety, tolerability, and pharmacokinetic characteristics for the treatment of non-muscle invasive bladder cancer (NMIBC).

The product has been independently developed by the company's Prodrug Accurate Drug Delivery platform and is an oral sustained-release product based on APL-1202 and will be the second-generation product of APL-1202 to support new clinical development globally. It inherits the oral administration of APL-1202 and the druggability of APL-1501 and has been improved by the design of prodrug molecules.