Nanoform will, in the fourth quarter of 2020, start the first ever human trial of a drug candidate nanoformed using its CESS technology.

Dosing will begin before year-end 2020 (previously: in 2021) and results are expected before the end of Q2/2021. The clinical trial is a progression of Nanoform’s first GMP campaign, which the company has now initiated, and will be made in partnership with Quotient Sciences, a provider of drug development and manufacturing solutions.

“The commencement of the first ever human trial of a drug nanoformed using our CESS technology is something we have been working tirelessly toward for many years, and we are very proud that our hard work has paid off in making the trial a reality ahead of schedule,” says Edward Hæggström, Nanoform’s CEO.

About the trial

In the clinical trial, Nanoform will investigate the behavior of an oral immediate release (IR) nanoformed formulation of piroxicam, an anti-inflammatory drug. Nanoform will manufacture the nanoformed piroxicam active pharmaceutical ingredient (API), which will then be transferred to Quotient’s facilities in Nottingham, UK. Quotient will support the project by developing a standard drug formulation for the nanoformed piroxicam API and administering it to healthy volunteers. By partnering with an integrated drug product formulation and clinical research organization, the timeline from manufacturing to dosing is reduced, states the company. The study aims to support the potential development of fast-acting forms of piroxicam and other drugs by demonstrating the clinical utility of Nanoform’s CESS nanoforming technology.

Nanoform’s in vivo and in vitro results suggest that by significantly reducing the size of drug particles, Nanoform’s CESS nanoforming technology can improve the pharmacokinetic properties of piroxicam. Poor bioavailability and solubility are major causes of failure in the drug development pipeline.

“Over the years, we have conducted hundreds of development programs on new drug candidates and we are incredibly pleased to be supporting Nanoform to validate their CESS technology,” saya Mark Egerton, CEO of Quotient Sciences. “We are committed to helping our customers bring new medicines to patients and eagerly await the outcome of the trial.”

Photo of Edward Hæggström, Nanoform’s CEO