Devonian Health Group Strengthens Thykamine™ Manufacturing Platform with Validated Chemical-Composition Fingerprinting and Biological Potency Assay
Rhea-AI Summary
Devonian Health Group (OTCQB: DVHGF, TSXV: GSD) announced independent validation and integration of key analytical and biological quality-control methods into the extraction and manufacturing of Thykamine™, its lead botanical drug candidate for fibro-inflammatory diseases.
Validated HPLC-MS chemical fingerprinting by Chromak Research and a U-937 cell-based biological potency assay measuring MIP-1β by Pacific BioLabs are now embedded in Devonian's QA/QP program. NMR spectroscopy is used as an orthogonal tool, with analyses to date showing >98% batch-to-batch chemical reproducibility. Ongoing external testing is expected to verify chemical consistency and biological activity across future Thykamine™ batches, aligning with FDA botanical drug development guidance for combined chemical and biological control strategies.
Positive
- NMR reproducibility >98% for Thykamine™ batch-to-batch chemical consistency to date
- Independent validation of HPLC-MS and U-937 potency assay by Chromak Research and Pacific BioLabs
- External ongoing testing of future Thykamine™ batches for chemical characterization and biological potency
Negative
- None.
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- Validated HPLC-MS, NMR and a validated cell-based biological potency assay using the U937 human cell line, with MIP-1β as a biological marker of Thykamine™'s anti-inflammatory activity, provide complementary chemical and biological measures of Thykamine™ and demonstrate reliable batch-to-batch consistency.
The Company's quality-control strategy combines validated High-Performance Liquid Chromatography coupled with Mass Spectrometry ("HPLC-MS") chemical fingerprinting, Nuclear Magnetic Resonance ("NMR") spectroscopy, and a validated cell-based biological potency assay using the U937 human cell line to measure macrophage inflammatory protein-1 beta ("MIP-1β") as a biological marker of Thykamine™'s anti-inflammatory activity.
The HPLC-MS analytical method has been independently validated by
Importantly, this independent third-party oversight will extend beyond method validation. Chromak Research Inc. and Pacific BioLabs are expected to continue to perform their respective HPLC-MS chemical characterization and U-937 cell-based potency testing on future Thykamine™ production batches. This ongoing external testing is designed to provide independent verification of both the chemical consistency and biological activity of Thykamine™ throughout future manufacturing.
"This approach is particularly relevant to botanical drug development because
"Ultimately, manufacturing reproducibility is also about patients. As Thykamine™ advances through clinical development, we want confidence that the product administered from one manufacturing batch to another is produced according to defined and reproducible chemical and biological quality standards", added Dr Boulet.
NMR spectroscopy is additionally used as an orthogonal analytical characterization tool to assess the overall chemical reproducibility of the botanical extract providing an additional measure of the consistency achieved through Devonian's proprietary extraction process. To date, NMR analyses have demonstrated greater than
Together, these complementary analytical and biological quality-control technologies provide a multi-layered framework for assessing Thykamine™ batch consistency, combining chemical fingerprinting, orthogonal structural characterization and biological potency testing, supported by independent third-party validation and ongoing external testing.
"We believe these developments represent an important advancement in the pharmaceutical development and manufacturing control of Thykamine™, which should help pave the way toward regulatory and commercial acceptance," concluded Dr. Boulet.
Addressing a Fundamental Challenge in Botanical Drug Development
Botanical drugs differ fundamentally from conventional single-molecule pharmaceuticals. They are generally complex mixtures containing multiple chemical constituents, and their biological activity may result from the contribution and interaction of multiple components rather than from a single identified molecule.
The FDA recognizes these characteristics and, through its Botanical Drug Development: Guidance for Industry ("BDDG"), addresses the need for appropriate chemical characterization of botanical drugs1.
The FDA's BDDG also recognizes that chemical testing alone may not always be sufficient to ensure quality and therapeutic consistency. In such circumstances, the FDA recommends that an appropriate biological assay be included in the product's control strategy. The FDA further indicates that a biological assay reflecting the drug's known or intended mechanism of action is preferred and that appropriate controls should be incorporated to demonstrate reproducible and predictable assay performance.
Building a Pharmaceutical-Grade Botanical Drug Platform
Devonian has developed a proprietary extraction and manufacturing process for Thykamine™, a complex pharmaceutical-grade botanical extract being investigated for its anti-inflammatory, antioxidant, immunomodulatory and anti-fibrotic properties.
The Company's manufacturing strategy combines controlled sourcing of botanical raw materials, standardized extraction conditions, analytical characterization, biological potency testing and pharmaceutical quality systems.
The combination of validated HPLC-MS chemical fingerprinting, NMR characterization, and validated U-937 cell-based potency testing represents another step toward establishing a comprehensive manufacturing and quality-control platform capable of supporting Devonian's expanding clinical development programs and potential future regulatory submissions.
About Thykamine™
Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress, including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, antioxidant and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies, as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large Phase II study in adult patients with mild-to-moderate atopic dermatitis. Both Thykamine™ and the SUPREX™ platform are covered by patents issued in several North American, European and Asian countries.
About Devonian Health Group Inc.
Devonian Health Group Inc. is a clinical-stage pharmaceutical company specializing in the development of drugs for various autoimmune fibro-inflammatory diseases, with novel therapeutic approaches targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of fibro-inflammatory autoimmune diseases, including but not limited to atopic dermatitis, radiodermatitis and ulcerative colitis.
Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Quebec, Canada where it owns a state-of-the-art extraction facility. Devonian is traded publicly on the TSXV (TSXV: GSD) and currently quoted on the OTCQB Venture Market (OTCQB: DVHGF).
For more information, visit www.groupedevonian.com
Reference
- Botanical Drug Development Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). December 2016 Pharmaceutical Quality/CMC
Forward-Looking Statements
All statements contained in this press release, other than statements of historical fact, including, but not limited to, statements relating to the Company's transition toward a focused biopharmaceutical development strategy centered on Thykamine™; and, generally, the statements contained under the "About Devonian" section, constitute "forward-looking information" or "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). These forward-looking statements are based on the Company's current expectations, estimates and assumptions as of the date of this press release. Such forward-looking statements may be identified by the use of words such as "anticipates," "believes," "expects," "intends," "plans," "may," "could," "would," "should," "will," or similar expressions, including negative or grammatical variations thereof, indicating that certain actions, events or results may, could or will occur or be achieved. The strengthening of the Thykamine™ manufacturing platform, the validation of chemical fingerprinting and biological potency assays, the complementarity of these technologies, the characterization of Thykamine™ at multiple levels, and the ability of the proprietary extraction process to reproducibly generate a complex botanical drug substance with a highly consistent chemical profile and biological activity, including batch-to-batch consistency, are forward-looking statements.
Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
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SOURCE Devonian Health Group Inc.