Nanoform Finland Plc, a medicine performance enhancing company, 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, an androgen receptor inhibitor 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) and Xtandi 4x40mg film-coated tablets. 

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.

According to the company, 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 preferable for patients in need of reducing their total number of daily pills.

The nanoformed enzalutamide API was manufactured at Nanoform’s state-of-the-art GMP manufacturing facility in Helsinki using its controlled 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.

“We are pleased to have achieved First Subject First Visit as planned. The initiation of this trial represents a key milestone as we advance the development of nanoenzalutamide in prostate cancer for patients.” said Edward Haeggström, CEO of Nanoform. “We continue our discussions with specialty pharma and value-added medicine partners to ensure this advance reaches the patients that need it the most. We see significant interest in nanocrystalline alternatives for Amorphous Solid Dispersions from pharma and value-added medicine partners, for whom this platform technology offers a differentiated and improved formulation that could reduce pill burden, provide a preferred route of administration, or improve patient experience, acceptance, and adherence.”