Dr. Andre Boulet reports

DEVONIAN HEALTH GROUP STRENGTHENS THYKAMINE MANUFACTURING PLATFORM WITH VALIDATED CHEMICAL-COMPOSITION FINGERPRINTING AND BIOLOGICAL POTENCY ASSAY

Devonian Health Group Inc. has successfully completed an independent validation and integration of key analytical and biological quality control technologies into the extraction and manufacturing process for thykamine, the company's lead active botanical drug candidate.

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-1beta) as a biological marker of thykamine's anti-inflammatory activity.

The HPLC-MS analytical method has been independently validated by U.S.-based Chromak Research Inc. while the U-937 cell-based biological potency assay has been independently validated by U.S.-based Pacific BioLabs. Both validated methodologies have been integrated into Devonian's quality assurance/quality program (QA/QP) governing the extraction, manufacturing and quality control of thykamine.

Importantly, this independent third party oversight will extend beyond method validation. Chromak Research 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 continuing 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 U.S. Food and Drug Administration (FDA) recognizes that chemical characterization of complex botanical products may need to be complemented by biological testing to help establish product quality and therapeutic consistency. The integration of these validated technologies directly into our quality-controlled extraction process represents an important step in the maturation of thykamine as a pharmaceutical product," said Dr. Andre Boulet, PhD, president and chief executive officer of Devonian.

"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-98-per-cent reproducibility from batch to batch, further supporting the high degree of chemical consistency achieved across independently manufactured thykamine production batches.

Together, these complementary analytical and biological quality control technologies provide a multilayered framework for assessing thykamine batch consistency, combining chemical fingerprinting, orthogonal structural characterization and biological potency testing, supported by independent third party validation and continuing 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 drugs.

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, anti-oxidant, 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, anti-oxidant 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 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 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 TSX Venture Exchange (symbol: GSD) and currently quoted on the OTCQB Venture Market (symbol: DVHGF).

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