These were from a relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutamide) tablet formulation, an alternative to the amorphous solid dispersion (ASD) used in Xtandi^®[1], the number one prescribed androgen receptor inhibitor^[2] first approved by the FDA in 2012, and by the EMA in 2013 to treat prostate cancer.

The nanoenzalutamide tablet formulation was developed in a partnership with the ONConcept^® Consortium (Bluepharma, Helm, and Welding) whereby Nanoform's proprietary controlled expansion of supercritical solutions (CESS^®) technology provides the opportunity for an improved and differentiated finished product. Tablet-burden and dysphagia are well-documented challenges for prostate cancer patients, and the development of a 160mg, single tablet per day regimen may be preferable for patients in need of reducing their total number of daily pills.

The single-dose, randomized, comparative bioavailability study, which was performed by a contract research organization (CRO) in North America and completed on January 25, 2024, compared enzalutamide 160mg filmcoated tablets (Bluepharma) and Xtandi^® 4x40 mg film-coated tablets (Astellas Pharma Europe B.V.). The clinical trial demonstrated promising results. Nanoform and ONConcept^® will further analyze these results prior to moving ahead to enter the phase of process validation and pivotal clinical trials.

A patent application for the nanoenzalutamide formulation has already been jointly filed by Helm and Nanoform. We aim for the product launch after the expiry of the enzalutamide substance patent in the respective territories. For the United States this patent expiry is expected in 2027, and in Europe in 2028. This unique IP position may allow the nanoenzalutamide product to enter the market prior to other generic competition based on the ASD formulation, which is currently patent protected in the US and Europe until 2033.

"We are delighted to have achieved promising results from this clinical trial, bringing closer the prospect of making the lives of prostate cancer patients around the world easier in their daily struggle managing this common disease", said Dr. Edward Haeggström, Chief Executive Officer of Nanoform. "This program exemplifies the opportunity available to create novel and improved dosage forms of existing medicines and to ensure that those drugs in clinical development are patient-centric before they reach the market. Together with our ONConcept^® Consortium partners, we look forward to executing licensing deals this year and in the future to commercialize nanoenzalutamide."