Nanoform has announced positive interim results from its clinical study.
The faster absorption data implies that small particles can indeed be powerful, states the company in its press release.
Phase I trial
Nanoform has received interim study results related to its Phase 1, Single-Centre, Part Crossover, Open-Label, Partially-Randomised Study Designed to Evaluate the Pharmacokinetic (PK) Profile of Piroxicam following Administration of Nanoformed Oral Immediate Release (IR) Piroxicam Tablet and an IR Reference Product in Healthy Subjects (UNICORN). These interim results are based on the first cohort of twelve healthy volunteers dosed in December 2020 at Quotient Sciences’ facilities in Nottingham, UK. Final results of the study are expected before the end of Q2 2021, as previously announced.
This first set of human data supports Nanoform’s value proposition that nanoparticles can enable faster dissolution rate, more rapid absorption, improve drug delivery performance, and ultimately generate patient benefit.
The interim results obtained from the ongoing clinical trial, suggest that a 20 mg nanoformed oral piroxicam tablet achieved significantly faster absorption when compared to a 20 mg reference oral piroxicam tablet (Felden) from the originator Pfizer. The time of maximum plasma concentration (Tmax) was obtained earlier than with the reference product. These interim results support the further development of fast-acting forms of poorly soluble drugs by using the CESS nanoforming technology, reports the company.