Nanoform, the medicine performance-enhancing company based in Helsinki, Finland, has initiated a trial to assess the relative bioavailability of its nanocrystalline enabled alternative to an amorphous solid dispersion (ASD) formulation of nanoenzalutamide and Xtandi®, a leading androgen receptor inhibitor used in prostate cancer treatment. The clinical trial, conducted by a contract research organization (CRO) in North America, involves a single-dose, randomized, comparative bioavailability study comparing enzalutamide 160 mg film-coated tablets and Xtandi 4×40 mg film-coated tablets. Bluepharma Farmaceutica S.A. and Astellas Pharma Europe B.V. manufacture these tablets, respectively. The clinical trial read-out is anticipated during Q1 2024.
Tablet-burden and dysphagia present challenges for prostate cancer patients, and Nanoform aims to address these issues by developing a 160mg, single tablet per day regimen using its technology and formulation expertise. This advancement could potentially reduce the total number of daily pills for patients. Nanoform’s CEO, Dr. Edward Haeggström, expressed satisfaction with achieving the First Subject First Visit milestone and highlighted the significance of this trial in advancing the development of nanoenzalutamide for prostate cancer patients.
The company is engaged in discussions with specialty pharma and value-added medicine partners to ensure the technology reaches the patients who need it the most. Nanoform believes that its nanocrystalline alternatives for Amorphous Solid Dispersions generate considerable interest among pharmaceutical and value-added medicine partners, offering a differentiated and improved formulation that may reduce pill burden, provide a preferred route of administration, or enhance patient experience, acceptance, and adherence.
If the trial results are positive, Nanoform and its partners plan to pursue one or more license and/or commercial supply agreements in 2024 while retaining a 25% share of the net income. The development program has been equally funded by Nanoform and three other parties. The nanoformed enzalutamide API was produced at Nanoform’s GMP manufacturing facility in Helsinki using its proprietary controlled expansion of supercritical solutions (CESS®) technology, designed to enhance bioavailability, reduce the need for polymers or excipients, improve dose loading, and provide a superior patient experience. Xtandi is a registered trademark of Astellas Pharma Inc.
Nanoform is a medicine performance enhancing company that collaborates with pharma and biotech partners globally to develop new and improved medicines using its platform technologies. The company focuses on reducing clinical attrition and enhancing drug molecules’ performance through its nanoforming technologies and formulation services. Nanoform’s capabilities include GMP manufacturing, spanning the small to large molecule development space with a focus on addressing key issues in drug solubility and bioavailability and enabling novel drug delivery applications.
Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Danske Bank A/S, Finland Branch, serves as the certified adviser.