Hydrocortisone Acetate

QUEBEC CITY--( BUSINESS WIRE )--Devonian Health Group Inc. (“ Devonian ” or the “ Corporation ”) ( TSXV: GSD; OTCQB: DVHGF ), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, today 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. The assays were conducted at Department of Microbiology, Infectious Diseases, and Immunology in the Faculty of Medicine at Université Laval (Quebec City) under the leadership of Pr Louis Flamand, PhD, MBA (1) in collaboration with Dr John Sampalis, PhD, Epidemiologist, Medicine Faculty, McGill University and Dr Charles Lynde, MD from Lynde Dermatology and Associate Professor in the Department of Medicine at the University of Toronto. The primary objective of the study was to compare the anti-inflammatory potency of Thykamine™ to other anti-inflammatory agents in the market, specifically betamethasone valerate, clobetasol, crisaborole, 21-acetate hydrocortisone, pimecrolimus and prednisone. The experiment involved treating lipopolysaccharide (LPS) stimulated U937 monocytic cells with each agent. Anti-inflammatory potency was assessed by the percent inhibition of the activity of four cytokines induced by each agent. The four cytokines tested were MCP-1, MIP-1α, MIP-1β and RANTES that have been implicated in several autoimmune diseases. Percent inhibition was calculated as the reduction in lipopolysaccharide (LPS) induced cytokine activity after addition of the agent. Given that the aim of anti-inflammatory drugs is to dampen cytokine induced inflammation, these results can be used as inference to overall anti-inflammatory efficacy. All agents were tested at four increasing concentrations except for pimecrolimus that was tested at three concentrations. All culture conditions were run in hexaplicate (n=6). Cell-free supernatants were collected and immediately assayed for cytokine concentration using Pro-Carta 6 plex (Life Technologies). U937 secreted amounts of IL-6 or IL-10 that were below the detection limits of the assay and were not included in the analyses. 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. “ These results support the wide spectrum anti-inflammatory properties of Thykamine™ with potency that is superior to currently marketed anti-inflammatory agents. This study indicates a multi mode of action of Thykamine™ affecting several cytokines and other biomarkers, supporting the clinical efficacy demonstrated in phase 2 studies in ulcerative colitis and atopic dermatitis in adults,” said Dr Louis Flamand, lead study investigator. “ The high potency and previously established clinical efficacy of Thykamine™ , combined with its placebo-like safety, should compel practitioners to consider its use as a first line treatment, especially with the potential safety concerns of the present standard of care,” said Dr Lynde, who was consulted on the current study and was the lead investigator in Devonian’s phase 2 study in adults with mild-to-moderate atopic dermatitis. The study’s co-investigator Dr. John Sampalis, Clinical Epidemiologist, and Professor of Medicine at McGill with extensive experience in the evaluation of treatments for autoimmune disorders commented: “ The results of this in vitro study are extremely encouraging. The favorable safety profile of Thykamine™ as demonstrated in human clinical studies and its high anti-inflammatory potency proven in this study, would position Thykamine™ as a possible first line treatment of choice for several autoimmune conditions in the early stages of the disease. This can result in steroid sparing effect and reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long term negative consequences.” Investigators of this study are planning to submit the results in a peer-reviewed journal. (1) Pr. Louis Flamand is a director on the board of directors of the Corporation 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 protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. 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, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the TSX Venture Exchange (the “Exchange”) (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF). 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 economical impact of clinical study, the efficiency of the high anti-inflammatory potency proven and the position of the Thykamine™ as a possible first line treatment of choice for several autoimmune conditions in the early stages of the disease and the reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long term negative consequences, and, generally, the above “About Devonian” and “About Altius” paragraphs, which essentially describes the Corporation’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation 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 Corporation 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. 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.

Pivotal Phase 3 Data Met Pre-defined Outcomes - Achieving a Clinical Response by Day 15 and Clinical Remission by Day 29 On Track for NDA Submission in Q1 2025 CONCORD, Mass., Jan. 9, 2025 /PRNewswire/ -- Cristcot, a clinical-stage pharmaceutical company advancing innovative therapies for gastrointestinal diseases, today announced positive topline results from its pivotal Phase 3 cessa clinical trial evaluating its novel hydrocortisone acetate (HCA) suppository administered with the Sephure® suppository applicator in patients with ulcerative colitis (UC) of the rectum. The cessa Phase 3 trial was constructed to evaluate the safety and efficacy of Cristcot's investigational HCA suppository formulation designed to halt acute flares in UC. The study examined the treatment for use alone as monotherapy or with other maintenance therapies (e.g., 5-ASAs, biologics, anti-TNFs, Jak inhibitors, etc.). Key Phase 3 Study Results : The cessa Phase 3 trial randomized 171 patient subjects, meeting the study protocol criteria, who were experiencing moderate to severe active UC of the rectum at the time of enrollment. The study was conducted at multiple research sites around the world and patient subjects were randomized to receive either once-daily (QD), twice-daily (BID) dosing of the 90 mg hydrocortisone acetate suppository or placebo for 28 days, followed by a 10-day taper period. Primary Endpoint: Clinical Remission by Day 29 (Visit 7) The trial achieved its primary endpoint of clinical remission, defined as a Modified Mayo Score of 0-2, which includes rectal bleeding sub-score of 0, reduction of stool frequency from baseline with sub-scores of 0 or 1 and mucosal healing as determined by an endoscopic sub-score of 0 or 1. In the once-daily (QD) treatment arm, 23.0% of patients achieved clinical remission by Day 29. In the twice-daily (BID) treatment arm, 17.5% of patients achieved clinical remission by Day 29. When pooling both treatment active treatment arms, 20.2% of patients receiving active treatment reached clinical remission, compared to only 2.1% in the placebo group, demonstrating a statistically significant benefit. Secondary Endpoints: Clinical Response by Day 15 (Visit 5) Rapid clinical response for both, rectal bleeding = 0 and reduction of stool frequency = 0 or 1, was observed in both active treatment arms by Day 15. Safety Profile The treatment was well-tolerated, with no adverse events of statistical significance reported across treatment arms. Side effects observed were generally mild and consistent with those typically associated with corticosteroid use. Patient Compliance Notably, the trial demonstrated high compliance rates across treatment arms, with 97% compliance for the once-daily regimen. "UC patients are urgently in need of a therapeutic option to manage intermittent and acute flares, inherent in the disease profile, as current therapies often take several months to induce clinical response and up to 52 weeks to achieve remission," said Jennifer Davagian, Founder and Chief Executive Officer, Cristcot. "During the first quarter of 2025 we will be finalizing our NDA submission as we continue to build our manufacturing and commercial capabilities to bring this potentially transformative therapy to patients in the U.S. We are also evaluating marketing partnerships that would help accelerate the commercialization of the drug to market. We look forward to providing further updates in the coming months." "Subject to FDA approval, the ability for patients to achieve symptomatic relief in as little as two weeks and clinical remission in just four weeks will be a significant advancement for UC patients," added Dr. Monika Fischer, MD, MSc, FACG, AGAF, Chief Fellow in the Division of Gastroenterology and Hepatology, Indiana University Department of Medicine. "This novel therapy is positioned to fill a critical gap in the treatment of ulcerative colitis and possibly related conditions. A novel topical steroid therapy can allow physicians to better manage acute crisis episodes and/or transition patients from one maintenance therapy to another, while reducing the burden to both patients and payers. These results demonstrate Cristcot's potential to transform how we approach flare management and change the treatment paradigm for ulcerative colitis. Cristcot's new product is a potential new best-in-class therapy that delivers better efficacy through its unique release and absorption profile." About the cessa Trial This pivotal Phase 3 trial was designed to evaluate the safety and efficacy of Cristcot's hydrocortisone acetate 90-milligram suppository in patients with ulcerative colitis of the rectum. This was a randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years and older. Conducted across multiple global sites, the trial enrolled 784 patient subjects with 171 meeting the criteria of the protocol who received twice-daily dosing of the suppository for 28 days, followed by a 10-day taper period. The study's primary endpoint was clinical remission at Day 29, defined by a Modified Mayo score of 0-2 including zero bleeding, reduction of stool frequency and mucosal healing. Secondary endpoints included rapid symptom relief, with significant clinical response of a reduction in both bleeding and stool frequency observed as early as Day 15. Baseline Characteristics: Male or non-pregnant, non-lactating females aged 18 years and older. Subjects with a confirmed diagnosis of UC with an endoscopic score 2-3 extending no further than 15 centimeters (cm) from the anal verge as assessed by endoscopic procedure performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have an endoscopic score of 2-3 only in the rectum at the time of the screening endoscopy (endoscopic score 0-1 beyond 15 cm from the anal verge is not exclusionary). Modified Mayo sub-score for stool frequency of 1-3. Modified Mayo sub-score for rectal bleeding of 0-2. Modified Mayo endoscopic sub-score of 2-3. Total Modified Mayo Score (without physician global assessment) of 4-8. About Cristcot's HCA Suppository Cristcot's investigational HCA suppository formulation is a novel therapy delivered using the Sephure® suppository applicator, the small-volume suppository ensures precise placement, minimizing discomfort and leakage. This innovative delivery system may likely enhance patient compliance. Unlike traditional corticosteroid treatments, the suppository's differentiated mechanism of action allows for rapid metabolism and localized efficacy, reducing systemic exposure. About Ulcerative Colitis UC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms often include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares originate in the rectum, and untreated inflammation can progress to more extensive disease, leading to hospitalization or surgery. There is no cure for UC and breakthrough flares, even while taking maintenance medication, is a known characteristic of the disease profile. Over 55% of UC patients experience 3-5 flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential. Gaps remain in addressing flares quickly and effectively, highlighting the need for targeted therapies that can provide rapid symptom relief and remission. About Cristcot Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, a novel hydrocortisone acetate suppository, is positioned to become the first line therapy for ulcerative colitis. . Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Austin, Texas. For more information, please visit and connect with us Linkedin. Forward-Looking Statements Certain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Example of forward-looking statements include, but are not limited to, the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, 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. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. Contacts Mark C. Ensign, COO/CSO [email protected] Tanner Kaufman / Shana Marino FTI Consulting [email protected] / [email protected] SOURCE Cristcot WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED