Nanoform Finland, the medicine performance enhancing company, has 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, randomised, comparative bioavailability study, which is performed by a contract research organisation (CRO) in North America, compares enzalutamide 160 mg film-coated tablets (Bluepharma Farmaceutica SA) and Xtandi 4x40 mg film-coated tablets (Astellas Pharma Europe BV).
Clinical trial read-out is expected during Q1 2024.
Tablet burden and dysphagia are well-documented challenges for prostate cancer patients and the development of a 160 mg, 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.
“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 Dr Edward Haeggström, Chief Executive Officer 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.”
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 state-of-the-art 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.