Devonian Advances Thykamine™ Patent Strategy with Proprietary Fingerprint and Robust Manufacturing Controls
The Thykamine™ fingerprint defines eight specific chemical components present in precise ratios, established using advanced HPLC-MS (High-Performance Liquid Chromatography–Mass Spectrometry) analytical methods. The HPLC-MS methodology has demonstrated high reproducibility across manufactured batches of Thykamine™, a result independently confirmed by NMR (Nuclear Magnetic Resonance) analysis, showing ≥98% confidence in batch-to-batch consistency.
Batch reproducibility was further validated through potency assays using a U-937 human cell-based model, demonstrating that every batch of Thykamine™ exhibits equivalent biological activity. These assays confirmed consistent inhibition of key inflammatory cytokines, including RANTES and MIP-1β, reinforcing the functional equivalence of each production batch. The potency assay is currently being validated for inclusion in the Chemistry, Manufacturing and Controls (CMC) section of Thykamine™ production.
Collectively, the HPLC-MS fingerprinting, NMR confirmation, and potency assays will form an integral part of Devonian's CMC framework for Thykamine™ production, reinforcing regulatory preparedness and ensuring the level of manufacturing robustness required for pharmaceutical development.
Dr.
This milestone reinforces Devonian's commitment to scientific rigor, intellectual property protection, and pharmaceutical-grade manufacturing as the Company continues to advance Thykamine™ through development.
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, anti-oxidative 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 SUPREX™ platform are covered by patents issued in several North American, European and Asian countries.
About Devonian
Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary,
For more information, visit www.groupedevonian.com.
Cautionary Note Regarding Forward-Looking Statements
All statements, other than statements of historical fact, contained in this press release including, but not limited to those relating to the Common Shares consolidation; the anticipated post-consolidation trading price of the Common Shares; the potential impact of the consolidation on investor interest and liquidity; the ability to satisfy minimum price or other listing requirements of
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
Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.
View original content to download multimedia:https://www.prnewswire.com/news-releases/devonian-advances-thykamine-patent-strategy-with-proprietary-fingerprint-and-robust-manufacturing-controls-302688840.html
SOURCE