Thykamine (PUR 0110) / Devonian Health Group - LARVOL DELTA

Devonian Announces Positive in Vivo Results of Thykamine on Gene Expression Associated With Fibrosis (Businesswire) - "Devonian Health...today announced positive results from a gene analysis conducted as part of in vivo study in STAM mouse model...Thykamine treatment was associated down regulation of key genes associated with the progression of inflammatory diseases toward fibrosis. These include inhibitory (%) effects on inflammatory-related genes and fibrosis-related genes namely: Act2: up to 57%; TGFβ : up to 49.3 % (p<0.05); Ctgf: up to 44.2%; Ccl2: up to 77.28% (p<0.005); MMP9: up to 58.2% (p<0.005); Timp1: up to 73.5% (p<0.0005); Ccr2: up to 70.8% (p<0.0005); Socs3: up to 46.7%; SerpinF: up to 62.1% (p<0.05); IFNγ: up to 73.1% (p<0.05....Results will be published in a peer-reviewed scientific publication in 2025."

Preclinical • Fibrosis

Devonian Announces the Filing of a New Provisional Patent Application Relating to the Use of Thykamine for Treating Metabolic Dysfunction-Associated Steatohepatitis (MASH) (Businesswire) - "Devonian Health Group...announces the filing of a new provisional patent application directed to the use of Thykamine for treating metabolic dysfunction-associated steatotic liver disease (MASLD), such as MASH. Backed by in vivo data, the provisional patent application displays the potential effectiveness of thylakoid extracts in treating and slowing the progression of metabolic dysfunction-associated steatotic liver disease (MASLD), such as MASH."

Patent • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Devonian Reports Positive Results in MASH Liver Study (Businesswire) - "The study investigated the effects of Thykamine™ on liver disease progression in the widely used STAM mouse model of MASH/fibrosis at SMC Laboratories in Japan. In this model, diabetic mice were fed a high fat diet and rapidly to develop fatty liver disease caused by inflammation and a buildup of fat in the organ. Resmetirom, the first drug approved by US-FDA for the management of MASH, was used as positive control at an oral dose of 3.0 mg/kg once a day for 3 weeks...Thykamine treatment decreased liver type collagen type I expression, collagen type III score, F4/F80 expression, Ly-6G expression and MARCO (macrophage receptor with collagen structure) expression. The effects on these markers were comparable to the effects of Resmeritom. Overall, progression of liver fibrosis was reduced by Thykamine treatment. Gene expression analysis data should be released shortly. The complete MASH preclinical results are planned to be submitted for publication in 2025."

Preclinical • Metabolic Dysfunction-Associated Steatohepatitis

Devonian Health Group Inc. Reports Superior Anti-Inflammatory Potency of Thykamine in Comparative In Vitro Study (Businesswire) - "Devonian Health Group Inc...announced the results of its in vitro comparative study, which demonstrate the anti-inflammatory effect of Thykamine, with superior potency on the inflammatory biomarkers as compared to currently marketed anti-inflammatory agents, which included various corticosteroids and a phosphodiesterase inhibitor....When compared to the other agents, Thykamine™ showed clinically important and statistically significant higher inhibition potency for MCP-1 (by 28% to 136%; P< 0.009), MIP-Alpha (by 30% to 108%; P < 0.001), MIP-1 Beta (by 39% to 111%; P < 0.001). For RANTES higher inhibition was observed for all agents (by 47% to 258%) except for Crisaborole and Prednisone. In this assay, pimecrolimus did not inhibit any of the cytokine tested."

Preclinical • Inflammation

Devonian Bolsters Intellectual Property With Issuance of U.S. Patent Covering a Method of Treatment of Inflammatory Bowel Disease (Businesswire) - "Devonian Health Group Inc...announced that the United States Patent and Trademark Office ('USPTO') has issued patent no. 11,723,938 B2 entitled, 'Thylakoid Extract Composition and Formulation for the Treatment of Inflammatory Bowel Disease' covering a method for treating inflammatory bowel disease ('IBD') such as ulcerative colitis and Crohn’s disease in a human subject with an effective amount of active thylakoid extract."

Patent • Immunology • Inflammatory Bowel Disease

Phase 2 Trial Of A Novel Botanical Topical Anti-Inflammatory Drug, Pur 0110, In Adults With Mild-To-Moderate Atopic Dermatitis (WCD 2023) - "PUR 0110 cream 0.10% demonstrated improvement in signs and symptoms of atopic dermatitis including rapid skin clearing and reduction of pruritus. This dual action, along with its favorable safety and tolerability profile, could make PUR 0110 a useful therapeutic option for the treatment of atopic dermatitis."

Clinical • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Devonian Health Group Receives a Notice of Allowance for Issuance of a U.S. Patent On a Method of Treatment of Inflammatory Bowel Disease. (Businesswire) - "Devonian Health Group Inc...is pleased to announce that the United States Patent and Trademark Office ('USPTO') issued a Notice of Allowance for Devonian’s Patent application No.: 16/998.004 entitled 'Thylakoid Extract Composition and Formulation for the Treatment of Inflammatory Bowel Disease'. This U.S. patent application is an addition to Devonian’s existing patent portfolio relating to thylakoids developed by the company such as PUR0110 (Thykamine™). The allowed U.S patent application is directed to a method for treating inflammatory bowel disease (IBD) such as ulcerative colitis and Crohn's disease in a human subject with an effective amount of active thylakoid extract."

Patent • Inflammatory Bowel Disease • Ulcerative Colitis

Phase 2 Trial of Topical Thykamine in Adults With Mild to Moderate Atopic Dermatitis. (PubMed, J Drugs Dermatol) - "2022;21(10):1091-1097. doi:10.36849/JDD.6729."

Journal • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic Dermatitis (clinicaltrials.gov) - P2; N=162; Completed; Sponsor: PurGenesis Technologies Inc.; Terminated ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Devonian Health Group Provides More Details on Previously Announced Positive Topline Results From Phase 2 Clinical Trial of Thykamine in Adult Population with Mild-to-Moderate Atopic Dermatitis and the Grant of Stock Options (Businesswire) - P2, N=162; NCT03540043; Sponsor: PurGenesis Technologies Inc.; "Devonian Health Group Inc....provides further details on previously announced results of Thykamine™ Phase 2 clinical trial for the treatment of mild-to-moderate atopic dermatitis (AD)....IGA success rates at week 4 were 6.7% for placebo (vehicle cream), 19.0% for Thykamine™ cream 0.05% (p=0.053 vs placebo), 30.8% Thykamine™ cream 0.10% (p=0.014 vs placebo) and 12.1% for Thykamine™ cream 0.25% (p=0.461 vs placebo)....'With the successful completion of this dose ranging study, we can now move into phase 3 clinical development in the adult patients. We are also planning a clinical trial within the pediatric patient population'..."

P2 data • Atopic Dermatitis

Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic Dermatitis (clinicaltrials.gov) - P2; N=92; Recruiting; Sponsor: PurGenesis Technologies Inc.

New P2 trial • Atopic Dermatitis • Biosimilar • Dermatitis • Dermatology • Immunology

Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic Dermatitis (clinicaltrials.gov) - P2; N=162; Terminated; Sponsor: PurGenesis Technologies Inc.; N=92 ➔ 162; Trial completion date: Mar 2020 ➔ Jun 2020; Recruiting ➔ Terminated; Reached required analyzable sample size; COVID-19 recruitment challenges

Clinical • Enrollment change • Trial completion date • Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic Dermatitis (clinicaltrials.gov) - P2; N=92; Recruiting; Sponsor: PurGenesis Technologies Inc.; Trial completion date: Oct 2018 ➔ Mar 2020; Trial primary completion date: Sep 2018 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

Thykamine Extracts from Spinach Reduce Acute Inflammation In Vivo and Downregulate Phlogogenic Functions of Human Blood Neutrophils In Vitro. (PubMed, Biomedicines) - "Spontaneous fluorescence provided by carotenoid and chlorophyll pigments (488/675 nm) detected Thykamine on the surface, in the cytoplasm (mainly central where Golgi are present) and weakly in the nucleus of neutrophils. The results argue that SOD and pigments found in Thykamine are part of its antioxidant and anti-inflammatory properties shown in in vivo and in vitro models of inflammation."

Journal • Preclinical • Gastrointestinal Disorder • Immunology

Devonian Health group announces Notice of Allowance for a US patent application covering use of Thykamine for the treatment of ulcerative colitis (Businesswire) - "Devonian Health Group Inc....announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application No. 15/772,155, titled, 'Thylakoid Extract Composition and Formulation for the Treatment of Inflammatory Bowel Disease,' covering the use of Thykamine™ for the treatment of Ulcerative Colitis."

Patent • Inflammatory Bowel Disease • Ulcerative Colitis