The following three publications for MyMD Pharmaceuticals, Inc. were published and/or accepted for presentation in 2022 (1&2) and 2023 (3).:
- Journal of Drug Research
A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose of MYMD-1® Capsules in Healthy Male and Female Adult Subjects
Authors: Jenna Brager, Chris Chapman, Leonard Dunn, Adam Kaplin - British Society of Immunology, Liverpool, UK, December 5-8, 2022
Pharmacology and clinical profile of MYMD-1® (isomyosamine), an oral, selective, next-generation, TNF-alpha inhibitor that crosses the blood brain barrier
Authors: Jenna Brager, Ronald Christopher, Adam Kaplin, Chris Chapman - 62nd Annual Meeting and ToxExpo, Society of Toxicology, March 19-23, 2023 in Nashville, TN
A Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNFa, MYMD-1® (Isomyosamine), Significantly Reduced the Inflammation and Disease Severity in Murine Model of Collagen Antibody-Induced Arthritis
Authors: Chris Chapman, and Sonia Edaye
Upon completion of its second Phase II clinical trial, MyMD Pharmaceuticals Inc. submitted the results to the Journal of Drug Research. The manuscript, “A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose of MYMD1™ Capsules in Healthy Male and Female Adult Subjects” was accepted and published in the fourth quarter of 2022.
The data concluded that MYMD-1® single daily doses each of 150 mg, 300 mg, and 450 mg for 3 days and multiple daily doses of 600 mg for 6 days were safe and well tolerated in healthy subjects. In one dose group, there was a decrease in TNF-α levels found in MYMD-1® treated subjects, but no change in the levels in subjects given placebo. The increase in MYMD-1® exposure was proportional to dose across the dose range of 300 mg to 600 mg when administered as a single dose. There was minimal accumulation of MYMD-1® following 5 days of once daily dosing of MYMD-1® 600 mg. MYMD-1® half-life ranged from approximately 15 minutes to 45 minutes across all doses in the single ascending dose and multiple ascending dose portion of the study. Elimination of MYMD-1® included the renal pathway as a minor route. In conclusion, MYMD-1® will continue to be investigated in phase 2 clinical trials for the treatment of sarcopenia/frailty, Hashimoto’s thyroiditis and rheumatoid arthritis.
After the manuscript was accepted for publication, an abstract was submitted to the British Society of Immunology, Pharmacology and clinical profile of MYMD-1® (isomyosamine), an oral, selective, next-generation, TNF-alpha inhibitor that crosses the blood brain barrier.
Results concluded that MYMD-1® is an oral, small molecule that can penetrate all parts of the body, including the brain by 37% with MYMD-1® while the reduction was 29% with Etanercept. Additionally, in single and multiple dose clinical studies with MYMD-1® at daily oral doses up to 600 mg QD were safe and well tolerated in healthy adult subjects. In vitro and in vivo research together with early clinical studies with MYMD-1® support the continued clinical development for various autoimmune diseases.
After a successful presentation in Liverpool, an additional abstract was submitted to
The 62nd Annual Meeting and ToxExpo, Society of Toxicology, A Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNFa, MYMD-1 (Isomyosamine), Significantly Reduced the Inflammation and Disease Severity in Murine Model of Collagen Antibody-Induced Arthritis. Results showed that MYMD-1® administration at 450 mg/kg/day inhibited arthritis development in CAIA murine model, with in-life data consistent with histopathological findings. Unlike currently available TNF-α inhibitors, MYMD-1® can be given orally and is a promising drug for rheumatoid arthritis.
MyMD Pharmaceuticals Inc. is focused on its upcoming Phase II clinical trial for Rheumatoid Arthritis and submitting exciting ground-breaking data to the American College of Rheumatology’s Annual Meeting in San Diego, California.
Jenna Brager, PhD, RN, MS, is the Executive Vice President of Drug Development at MyMD Pharmaceuticals. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.
Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email jbrager@mymd.com.