News | February 24, 2021

Additional Positive Interim Results From Nanoform's Clinical Study

Source: Nanoform

Helsinki, Finland – Nanoform Finland Plc, an innovative nanoparticle medicine enabling company, today 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.

 

For further information, please contact:

Prof. Edward Hæggström, CEO

edward.haeggstrom@nanoform.com

+358 29 370 0150

For investor relations queries, please contact:

Henri von Haartman, Director of Investor Relations

hvh@nanoform.com

+46 7686 650 11

The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on February 24, 2020 at 08:10 a.m. Finnish time / 07:10 Swedish time.

About Nanoform

Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform’s platform technologies. The company focuses on reducing clinical attrition and on enhancing drug molecules’ performance through its nanoforming technologies and formulation services. Nanoform’s capabilities include GMP manufacturing, and its services span the small to large molecule development space with a focus on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806. For more information please visit http://www.nanoform.com