The faster absorption data implies that nanoparticle engineering may offer viable alternatives to complex formulation approaches. The results also provide hope for quickly introducing improved versions of existing products or adding value to those already in clinical development
Nanoform Finland, an innovative nanoparticle medicine enabling company, has announced further positive interim results from its ongoing clinical study. The fast absorption data implies that small is powerful and might offer viable alternatives to complex formulation approaches such as cyclodextrin based technologies.
Nanoform has received the second interim pharmacokinetic (PK) study results related to its Phase 1, single-centre, part crossover, open-label, partially-randomised study designed to evaluate the PK profile of piroxicam following administration of nanoformed oral immediate release (IR) piroxicam tablet and IR reference products in healthy subjects (UNICORN).
The first set of interim human data (released January 22, 2021) showed faster absorption of Nanoform’s CESS nanoformed formulation against Felden®, the reference product, marketed by Pfizer. In the second part of the study, Nanoform evaluated the performance of the same nanoformed piroxicam tablet formulation against a β-cyclodextrin coupled piroxicam oral tablet (Brexidol) marketed by Chiesi, a fast-absorbing formulation available on the market.
One of Nanoform’s value propositions is that CESS nanoparticles may offer viable alternatives to complex formulations. By avoiding the use of cyclodextrin it is potentially possible to achieve increased drug loads and smaller dosage forms (e.g., tablets and capsules). This was supported by the study, where the 20 mg CESS nanoformed oral piroxicam showed equal absorption performance when compared to a 20 mg Brexidol tablet. In addition, the standard deviation of absorption in the nanoformed formulation was lower than that of both marketed products, which may mean less variability in the therapeutic response in patients.
The nanoformed formulation was developed to prove the clinical utility of the CESS technology for fast acting forms of drugs. This has been addressed through this trial. As expected, the results indicate similar bioavailability to both reference products. This provides hope for quickly introducing improved versions of existing products or adding value to those already in clinical development.
This set of human data supports Nanoform’s claim that nanoparticles can enable faster dissolution rate, more rapid absorption, improve drug delivery performance, and ultimately generate patient benefit. These findings are relevant for drugs being developed where fast action is required, such areas include but are not limited to pain and inflammation, migraine, depression, cardiology, vertigo, stroke, epilepsy and erectile dysfunction; or where pill burden is an issue, such as people who have difficulty swallowing (e.g., children and elderly patients).
These interim results are based on the cohort of twelve healthy volunteers dosed in December 2020 and January 2021 at Quotient Sciences’ facilities in Nottingham, UK. Final results of the study are expected before the end of Q2 2021, as previously announced.