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Nanoform has completed the First Subject First Visit in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide.
Finnish medicine performance enhancing company, Nanoform, has announced, in a Jan. 5, 2024 press release, the completion of the First Subject First Visit (FSFV) in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide.
The single-dose, randomized, comparative bioavailability study, which is being performed by a North American contract research organization, will compare Nanoform’s nanocrystalline enabled alternative to an amorphous solid dispersion (ASD) formulation of nanoenzalutamide and the FDA-approved prostate cancer androgen receptor inhibitor, Xtandi, in prostate cancer patients. The trial will compare the bioavailability of one enzalutamide 160 mg film-coated tablets (Bluepharma Farmaceutica S.A.) with that of four Xtandi 40 mg film-coated tablets (Astellas Pharma Europe B.V.). As pill burden and dysphagia are documented as common challenges for prostate patients, the development of a single tablet per day regimen could be a preferable option.
“We are pleased to have achieved [FSFV] 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, CEO of Nanoform, in the press release. “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 [ASDs] 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.”
A readout from the clinical trial is expected in the first quarter of 2024. In the event that the results of the trial are positive, Nanoform and partners have reported that they will seek one or more license and/or commercial supply agreements for nanoenzalutamide during 2024, under the proviso of maintaining 25% share of net-income.