Nanoform Final Clinical Results Confirm Value Proposition for Pharmaceutical Industry
Helsinki, Finland, May 18, 2021 / PRNewswire / – Nanoform Finland Plc (“Nanoform“), an innovative company enabling nanoparticle medicine, today announced the completion and final results of its clinical study. The primary, secondary and facultative exploratory goals of the study have all been met. The results show that Nanoform’s CESS® The technology has enabled the development of a rapid-acting immediate release (IR) piroxicam tablet formulation with faster absorption and improved drug delivery performance compared to a standard reference IR tablet. The results of the study confirm the published interim results (January 22 and February 24) and supports the clinical utility of Nanoform’s technology and its potential applicability for the production of rapid-acting dosage forms for poorly soluble drugs.
Nanoform has now received the final clinical study report on the results of the pharmacokinetic (PK) study linked to its phase 1, single-center, partially crossover, open-label, partially randomized study designed to assess the PK profile of piroxicam after administration of oral piroxicam IR tablets and IR reference products in healthy subjects (UNICORN).
The primary objective of the study was to determine the pharmacokinetics and relative bioavailability of piroxicam following oral administration of single 20 mg nanoformed piroxicam IR tablets and the Felden reference product.® 20 mg tablets (Pfizer) in healthy fasting subjects. The secondary objective was to provide additional information on the safety and tolerability of piroxicam after administration of nanoformed piroxicam tablets in healthy subjects. The additional exploratory objective was to determine the pharmacokinetics and relative bioavailability of piroxicam after oral administration of single 20 mg nanoformed piroxicam IR tablets and the additional reference product Brexidol 20 mg tablets (Chiesi) in healthy subjects in the fasting state. . Brexidol is a β-cyclodextrin coupled formulation designed for rapid absorption, therefore rapid absorption for this benchmark product was expected in vivo.
Nanoformed tablets demonstrated a time to peak plasma concentration (Tmax = 1.75 h, ranging from 0.75 h to 4.00 h) earlier compared to the two reference products: Felden (Tmax = 2.75 h, ranging from 0.75 h to 12.00 h) and Brexidol (Tmax = 2.25 h, ranging from 0.5 h to 8.00 h). The slightly faster absorption observed for nanoformed piroxicam tablets compared to Brexidol shows that nanoforming can be used as an alternative or enhancement to complex formulation approaches, such as those using β-cyclodextrin, with the potential to have improved performance without the need for additional excipients. Thus, nanoforming can allow for simpler formulation strategies and higher drug loadings in final drug products compared to complex formulations, where high amounts of excipients are required and in turn restrict the drug content in the drug. formulated product.
There was no significant difference in peak plasma concentrations (Cmaxmax) between the products tested (nanoformed 2230 ng / ml, Felden 2230 ng / ml and Brexidol 2300 ng / ml). Nanoformed piroxicam tablets exhibited an increase in area under the curve (AUC) during the first hour after administration (AUC (0-1)) (1150 ng * h / ml), showing an improvement of 33 % compared to Felden (863 ng * h / ml) and was very similar to Brexidol (1180 ng * h / ml). These results demonstrate the rapid absorption of piroxicam from nanoformed tablets. The overall plasma exposure (AUC (0-last)) of nanoformed piroxicam (83,600 ng * h / ml) was similar to that of Felden (85,900 ng * h / ml) and was slightly lower than that of Brexidol (92,000 ng * h / ml). As indicated in the literature, the fraction of piroxicam absorbed after oral administration is close to 100%, and therefore the similarity of the AUC response between the IR dosage forms tested in this study was anticipated.
The variability in peak plasma concentration (coefficient of variation, CV) was found to be lower in nanoformed piroxicam tablets (15.6) than in the two reference products (Felden 18.8 and Brexidol 17.1). This may be due to a more uniform and reproducible total surface area for the nanoformed piroxicam drug particles in the tablet facilitating more uniform dissolution and subsequent absorption. Reduced concentration variability could potentially offer advantages in downstream response variation.
Nanoformed piroxicam was well tolerated and no adverse effects were reported. Certain side effects were observed with the two reference products.
The nanoformed formulation was developed at Nanoform to prove the clinical utility of CESS® technology for faster-acting forms of poorly soluble drugs. This has been resolved and confirmed by this test. The results indicate similar bioavailability to the two reference products, and the Cmax the values show no statistically significant difference. This gives hope to quickly introduce improved versions of existing products and add value to those already in clinical development. Data shows that small is powerful® and offers industry a viable alternative to complex formulation approaches, such as β-cyclodextrin-based technologies. These results pave the way for improved absorption and increased drug load while allowing simpler formulations to maximize patient benefits.
These results are relevant for all poorly soluble drugs, which account for 70-90% of small molecule therapies in development, and may in particular add value to drugs in development when rapid action is required. . These areas include, but are not limited to: pain and inflammation, migraine, depression, cardiology, dizziness, stroke, epilepsy and erectile dysfunction; or when the burden of the pill is a problem, such as people who have difficulty swallowing (eg children and elderly patients).
The final results are based on the cohort of twelve healthy volunteers dosed with december 2020 and January 2021 in the Quotient Sciences facilities in Nottingham, United Kingdom.
The Quotient Sciences study report is available at: https://nanoform.com/fr/articles-videos/
Chris roe, Senior Research Fellow at Quotient Sciences, will present the clinical study, objectives and results at the CPhI Discover online event May 20, 2021, “Overcoming the challenges of drug development through nanotechnology”: https://exhibitors.cphi.com/pdig21/agenda.html
Nanoform to Present Clinical Findings in Conjunction with Nanoform’s Already Scheduled Q1 / 2021 Report Conference Call and Online Presentation to Analysts, Investors and Media May 27, 2021: https://nanoform.com/en/invitation-to-presentation-of-nanoforms-q1-2021-report-on-may-27-2021/
For more information, please contact:
Edward Haeggström, CEO
[email protected] / +358 29 370 0150
For any commercial questions, please contact:
Christian jones, CCO
[email protected] / +44 7804 474771
For all investor relations questions, please contact:
Henri von haartman, director of investor relations
[email protected] / +46 7686 650 11
The information has been sent for publication, through the contact persons indicated above, on May 18, 2021, at 08:10 Finnish time / 7:10 a.m. Swedish time.
About the nanoform
Nanoform is an innovative company enabling medicine based on nanoparticles. Nanoform works in collaboration with pharmaceutical and biotechnology partners around the world to give hope to patients in the development of new and improved drugs using the technologies of the Nanoform platform. The company is focused on reducing clinical attrition and improving the performance of drug molecules through its nanoforming technologies and formulation services. Nanoform’s capabilities include GMP manufacturing, and its services span the small and large molecule development space with a focus on solving key drug solubility and bioavailability issues and building new applications. drug administration. Nanoform shares are listed on the first segment of the Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Advisor: Danske Bank A / S, Finland Branch, +358 40 562 1806. For more information, please visit www.nanoform.com.
This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform’s strategy, business plans and direction. The words may “,” will “,” could “,” should “,” should “,” expect “,” plan “,” anticipate “,” intend “, believe”, “estimate” , “Predict”, “project,” “potential”, “continue”, “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. forward-looking statements contained in this press release are based on the current expectations and beliefs of management and are subject to a number of risks, uncertainties and important factors which may cause actual events or results to differ materially from those expressed or implied by any forward-looking statement.statements contained in this press release, including, without limitation, anything relating to business, operations, clinical trials, supply chain, strategy i.e., Nanoform’s objectives and expected timelines, competition from other companies and other risks specified in Nanoform’s published prospectus (on May 22, 2020) in connection with Nanoform’s initial public offering (the “Prospectus”) under the heading “Risk Factors” and in our other filings or documents provided to the Finnish Financial Supervisory Authority in connection with the Prospectus. Nanoform cautions you not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise such statements to reflect any change in expectations or in the events, conditions or circumstances on which such statements may be based, or which may affect the likelihood that actual results will differ from those set forth in forward-looking statements. All forward-looking statements contained in this press release represent the views of Nanoform only as of the date hereof and should not be construed as representing its views as of any later date.
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