Nanoform initiates GMP campaign for first-in-human trial of nanoformed drug by year end – ahead of schedule 21st October 2020
Nanoform Finland Plc (“Nanoform”), an innovative nanoparticle medicine enabling company will, in the fourth quarter of 2020, start the first ever human trial of a drug candidate nanoformed using Nanoform’s proprietary 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 (“Quotient”), a leading provider of drug development and manufacturing solutions.
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. 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.
Nanoform is on track to achieve all its near-term business targets for 2020 and 2021 announced in relation to the IPO. “Start of first GMP project before end of 2020” has now been achieved, and “first dosing in humans in 2021” is on track to be already achieved in 2020 (previously: in 2021).
“The commencement of the first ever human trial of a drug nanoformed using our proprietary 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,” said Professor Edward Hæggström, Nanoform’s CEO.
“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,” said 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.”