Nanoform Finland Plc announced it had completed the First Subject First Visit (FSFV) in a trial to evaluate the relative bioavailability of its nanocrystalline enabled alternative; to an amorphous solid dispersion (ASD);formulation of nanoenzalutamide and Xtandi®, the number one prescribed androgen receptor inhibitor first approved by the FDA in 2012 to treat prostate cancer. The single-dose, randomized, comparative bioavailability study, which is performed by a contract research organization (CRO) in North America, compares enzalutamide 160 mg film-coated tablets (Bluepharma Farmaceutica S.A.) and Xtandi 4x40 mg film-coated tablets. Clinical trial read-out is expected during first quarter 2024.

Tablet-burden and dysphagia are well-documented challenges for prostate cancer patients, and the development of a 160mg, single tablet per day regimen enabled by Nanoform technology and formulation expertise may be preferred for patients in need of reducing their total number of daily pills. If the results are positive, Nanoform and its partners will seek one or more license and/or commercial supply agreements during 2024 and equally retain 25% share of the net-income. Nanoform and three other parties have equally funded this development program.

The nanoformed enzalutamide API was manufactured at Nanoform's GMP manufacturing facility in Helsinki using its proprietary ccontrolled expansion of supercritical solutions (CESS®) technology, designed to improve bioavailability, reduce the need for polymers or excipients, improve dose loading, and provide a superior patient experience.