BioNxt Signs Clinical Study Agreement and Commences Manufacture of Clinical Samples for Study of Transdermal Rotigotine Patch for Parkinson’s Disease

Rhea-AI Summary

BioNxt Solutions has signed an agreement to conduct a comparative drug absorption study for its transdermal Rotigotine patch aimed at treating Parkinson's disease. Scheduled for early Q2 2023, the study will assess bioavailability, skin adhesion, and skin tolerance against a leading brand. BioNxt is also ramping up the manufacture of clinical samples and developing in-house commercial manufacturing capabilities at its German facility. The Parkinson's disease therapeutic market is projected to grow, with Rotigotine patch sales expected to exceed $766 million by 2030. The company aims to leverage its proprietary TDS technology for future drug development.

Positive

• Executed agreement for a comparative drug absorption study of Rotigotine patch.
• Manufacturing clinical samples commenced for the study.
• Development of in-house commercial manufacturing capabilities at its German facility.
• Growing therapeutic market for Parkinson's disease with expected sales surpassing $766 million by 2030.

Negative

• None.

News Market Reaction – BNXTF

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+7.60% News Effect

On the day this news was published, BNXTF gained 7.60%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

VANCOUVER, BC / ACCESSWIRE / March 1, 2023 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that it has executed an agreement to carry out its comparative drug absorption study for the Company's transdermal ("TDS") Rotigotine patch for the treatment of Parkinson's disease. BioNxt has also commenced the manufacture of clinical samples for use in the study which is planned for early Q2 2023.

Further to BioNxt's press release dated February 13, 2023, the Company has finalized its plans for the human bioavailability study to be carried out by a qualified European contract research organization. The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. The study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches. The Company has also commenced the manufacture of transdermal clinical samples based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor").

BioNxt is working to develop in-house commercial manufacturing capabilities at its German drug development facility. This will include EU GMP-approved manufacturing and packaging equipment as well as a certified manufacturing line capable of producing pivotal trial materials compliant with commercial regulatory approval applications and final commercial products (transdermal and oral dissolvable). The Company expects to make further announcements regarding its commercialization capabilities over the coming months.

Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a controlled and steady supply of the drug over the course of 24 hours. The therapeutic market for Parkinson's disease is over 10 million people worldwide and growing. The top selling name brand product launched by the originator in 2007 independently sold over US$375 million of its Rotigotine TDS patches in 2021. According to Wissen Market Research, total global sales for Rotigotine patches were approximately US$518 million in 2021 with the market expected to surpass US$766 million by 2030.

BioNxt's Rotigotine transdermal patch is one product based on its 100% owned platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs. According to Research and Markets, the global transdermal skin patch market had a value of nearly US$6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimates the market will reach approximately US$20 billion by 2028.

BioNxt's wholly owned subsidiary, Vektor, is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sub-lingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global drug delivery market was valued at US$1,476 billion in 2021 and is expected to grow to US$2,047 billion by 2030.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.

BioNxt Solutions Inc.

Hugh Rogers, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422

Cautionary Statement Regarding "Forward-Looking" Information

Some of the statements contained in this news release are forward-looking statements and information within the meaning of applicable securities laws. Forward-looking statements and information can be identified by the use of words such as "expects", "intends", "is expected", "potential", "suggests" or variations of such words or phrases, or statements that certain actions, events or results "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements and information are not historical facts and are subject to a number of risks and uncertainties beyond the Company's control. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this news release.Accordingly, readers should not place undue reliance on forward-looking statements. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, except as may be required by law.

SOURCE: BioNxt Solutions Inc.

View source version on accesswire.com:
https://www.accesswire.com/741373/BioNxt-Signs-Clinical-Study-Agreement-and-Commences-Manufacture-of-Clinical-Samples-for-Study-of-Transdermal-Rotigotine-Patch-for-Parkinsons-Disease

FAQ

What is the purpose of BioNxt's drug absorption study for the Rotigotine patch?

The study aims to evaluate the bioavailability, skin adhesion, and skin tolerance of BioNxt's transdermal Rotigotine patch compared to the established brand.

When is the comparative drug absorption study for the Rotigotine patch expected to take place?

The study is planned for early Q2 2023.

What technology does BioNxt utilize for its drug delivery systems?

BioNxt employs its proprietary transdermal delivery system (TDS) technology for developing its Rotigotine patch.

How significant is the market for Parkinson's disease treatments?

The therapeutic market for Parkinson's disease is substantial, with global sales for Rotigotine patches projected to exceed $766 million by 2030.

What are BioNxt's plans for commercialization?

BioNxt is focused on establishing in-house commercial manufacturing capabilities compliant with EU GMP standards and plans to announce further developments in the coming months.