Nanoform Finland Plc announced it had received positive results from its own pre-clinical, in-vivo study of a nanocrystalline-enabled apalutamide oral formulation, which shows potential to enable a much smaller tablet than Erleada® [1], a nonsteroidal antiandrogen (NSAA) blockbuster amorphous solid dispersion (ASD) medicine used to treat prostate cancer.
The nanocrystalline-enabled formulation provided high serum concentration (Cmax), fast time to peak drug concentration (Tmax), and 100% absolute bioavailability. This study was conducted in order to provide further validation of nanocrystalline formulations as effective alternatives to amorphous solid dispersions.
“These encouraging results follow our successful clinical study on nanoenzalutamide, our improved version of yet another blockbuster ASD product in the prostate cancer field, and further validates the opportunity to leverage our formulation platforms to help patients by transitioning to nanoformed products,” said Dr. Edward Haeggström, CEO of Nanoform. “Through our proprietary AI technology platform, we’ve identified that most ASD products are amenable for improvements with Nanoform technologies, covering multiple therapy areas including cancer, HIV and CNS.”
ASDs are used to enable poorly soluble drugs, and there are over 50 such products on the global market worth +$50 billion in annual sales, and hundreds more in development. ASDs require a high polymer content leading to reduced drug loading and large or many tablets, presenting a challenge for many patient populations, as well as cost, manufacturing and environment.
Nanoform’s nanocrystalline formulations enable significantly higher drug loading, allowing for smaller pills and a reduced pill burden. Its technology is free from organic hydrocarbon solvents, offering an environmentally sustainable alternative. Nanoform intends to conduct more similar studies on other APIs. The company was recently granted match funding of 4.3m Euros from Business Finland towards creating formulation platforms around four key drug delivery areas of oral, inhaled, long acting injectables and high drug load subcutaneous biologics.
Nanoform’s technology delivers some of the world’s smallest nanoparticles at clinical and commercial scale. Used by multiple pharmaceutical innovator partners, it is suitable for new product developments, lifecycle management through improved reformulations, and differentiated generics across oral, hydrogel, ophthalmic, inhalable, and injectable dose forms. Nanoform’s state-of-the-art development and manufacturing facility is in Helsinki, Finland.
[1] Erleada is a registered trademark for Apalutamide owned by Johnson & Johnson / Janssen Biotech, Inc.
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