isomyosamine (MYMD-1) / TNF Pharmaceuticals, Bascom Palmer Eye Institute - LARVOL DELTA

TNF Pharmaceuticals Collaborates with DADA2 Foundation for Compassionate Use Study of Isomyosamine in Rare Pediatric Autoinflammatory Disease (Businesswire) - "TNF Pharmaceuticals, Inc...announced that it has formed a philanthropic collaboration with the DADA2 Foundation, a nonprofit organization seeking innovative ways to accelerate research into the rare inflammatory disease DADA2 (Deficiency of Adenosine Deaminase 2). Together, the parties are expected to initiate a Compassionate Use (Expanded Access) study evaluating TNF’s lead candidate isomyosamine as a potential treatment."

Commercial • Inflammation • Rare Diseases

TNF Pharmaceuticals and Renova Health Report Positive Results in Identifying Targets for Treating TNF-Driven Inflammation in Patients Receiving GLP-1 Agonists (Businesswire) - P=NA | N=30,000 | "TNF Pharmaceuticals...and Renova Health...announced positive results from the first stage of a general practice population study focusing on patients receiving GLP-1 agonists. The study series is expected to evaluate the impact of the Company’s novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management in patients who are a) on GLP-1 agonists, b) candidates for treatment with GLP-1 agonists, or c) probably not suitable for treatment with weight loss therapy...In coordination with Renova Health, the purpose of this first stage was to analyze 30,000 patients already under the care of primary care physicians and identify convergences between the use of GLP-1 agonists and chronic disorders linked with increased risk of inflammation. The data were parsed into three cohorts depending on prespecified criteria."

Clinical data • Inflammation

Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: TNF Pharmaceuticals, Inc.

New P2 trial • Geriatric Disorders • Inflammation • Musculoskeletal Diseases • Orthopedics • Sarcopenia

TNF Pharmaceuticals Delivers Platform Presentation of Oral TNF-Alpha Inhibitor Isomyosamine at British Geriatrics Society’s Spring Meeting 2025 (Businesswire) - "TNF Pharmaceuticals, Inc...announced today that a platform presentation of an abstract titled 'Isomyosamine for the Treatment of Sarcopenia in Older Adults' was delivered by Mitchell Glass, M.D., President and Chief Medical Officer of TNF, at the British Geriatrics Society (BGB) Spring Meeting 2025, held April 9-11, 2025, in Belfast, Ireland and online. During his presentation, Dr. Glass spoke about the Company’s small-molecule TNF-alpha (TNF-α) inhibitor, isomyosamine, which has shown potential for regulating pro-inflammatory cytokines associated with sarcopenia."

Clinical • Sarcopenia

TNF Pharmaceuticals Delivers Podium Presentation of Novel Oral TNF-Alpha Inhibitor at Premier International Conference on Frailty and Sarcopenia (Businesswire) - P2a | N=NA | "TNF Pharmaceuticals...announced that data from the Phase 2a clinical trial of its oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine was presented last week in a podium session at the peer-reviewed 15th International Conference on Frailty and Sarcopenia Research (ICFSR) held March 12-14, 2025, in Toulouse, France....The presentation included positive Phase 2a clinical data showing decreases of biomarkers associated with TNF-α activation in elderly patients with sarcopenia."

P2a data • Sarcopenia

TNF Pharmaceuticals Initiates Phase 2b Clinical Trial of First Oral TNF-Alpha Inhibitor (Businesswire) - "TNF Pharmaceuticals, Inc...today announced the initiation of a fully funded Phase 2b clinical trial evaluating oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery....Sixty patients will be treated with isomyosamine or placebo for up to 90 days after surgery. The study will measure the extent and time course of recovery to evaluate functional improvement, comparing active dosing to placebo."

Trial status • Sarcopenia

TNF Pharmaceuticals Launches Study Series Aimed at Preserving Lean Muscle Mass During GLP-1 Weight Loss Treatment (Businesswire) - "TNF Pharmaceuticals, Inc...today announced that it has initiated the first in a series of studies to evaluate the impact of its novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management."

New trial • Metabolic Disorders • Obesity

TNF Pharmaceuticals Announces Positive Clinical Data Supporting Clinical Trial Expansion (Businesswire) - P2 | N=40 | NCT05283486 | Sponsor: MyMD Pharmaceuticals, Inc. | "TNF Pharmaceuticals, Inc...today announced that it has achieved a key safety data milestone supporting expanded and longer-term clinical studies of its novel TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in multiple indications. The Company successfully completed an FDA-recommended study of isomyosamine that demonstrated clinical safety throughout 13 weeks of treatment at all dose levels evaluated...TNFA plans to launch a Phase 2b clinical trial of isomyosamine’s efficacy in sarcopenia early in the first quarter of 2025."

New P2b trial • P2 data • Sarcopenia

MyMD Pharmaceuticals Plans FDA-Cleared Phase 2 Clinical Trial of MYMD-1 in Rheumatoid Arthritis (Businesswire) - "MyMD Pharmaceuticals, Inc...announced today that its Investigational New Drug (IND) application for a Phase 2 clinical trial of oral MYMD-1 as a treatment for rheumatoid arthritis (RA) was recently cleared by the U.S. Food and Drug Administration (FDA), and plans are underway for trial launch in the first quarter of 2024....Under this IND, the Phase 2 clinical trial of MYMD-1 will be a randomized placebo-controlled study that is expected to enroll approximately 60 patients with active rheumatoid arthritis. Patients will receive oral MYMD-1 dosing of 1050 mg."

IND • New P2 trial • Immunology • Rheumatoid Arthritis

Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: MyMD Pharmaceuticals, Inc. | Recruiting ➔ Completed

Trial completion • Inflammation • Sarcopenia • IL6 • TNFRSF1A

MyMD Pharmaceuticals to Present Updated Statistically Significant Phase 2 Data for MYMD-1, Potential TNF-α Market Disrupter, at BioFuture 2023 (Businesswire) - "MyMD Pharmaceuticals, Inc...announced that it plans to share information on the Company and its product pipeline, including an update on recent positive phase 2 study results for MYMD-1 in sarcopenia, at the upcoming BioFuture 2023 Meeting. Chris Chapman, MD, president, director, and chief medical officer at MyMD Pharmaceuticals, is scheduled to present at the conference on October 6th, 2023, at 9:30am EST. Jenna Brager, PhD, executive vice president of drug development at MyMD Pharmaceuticals, is scheduled to participate in a panel discussion...on October 5th, 2023, at 11:45am EST....The Company will present the clinical safety report to the FDA with plans to seek future guidance for a Phase 3 clinical trial in sarcopenia. If approved, MYMD-1 has the potential to be the first drug approved by FDA for the condition, an age-related decline in muscle mass and physical function which leads to greater risk of hospitalization, disability, and death."

P2 data • Immunology • Sarcopenia

FDA Accepts MyMD Pharmaceuticals’ Investigational New Drug Application (IND) for Phase 2 Study of oral TNF-α inhibitor MYMD-1 in Rheumatoid Arthritis (RA) (Businesswire) - "MyMD Pharmaceuticals, Inc...announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) to evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of oral TNF-α inhibitor MYMD-1® in patients with active rheumatoid arthritis (RA). The application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel® (etanercept). The Company plans to initiate discussions with CRO vendor IQVIA on timing of a Phase 2 study in this indication."

IND • New P2 trial • Immunology • Rheumatoid Arthritis

MyMD Pharmaceuticals Reports Statistically Significant Positive Topline Phase 2 Results for Next Generation Oral TNF-α Inhibitor MYMD-1 in Sarcopenia/Age-Related Frailty (Businesswire) - P2 | N=40 | NCT05283486 | Sponsor: MyMD Pharmaceuticals, Inc. | "MyMD Pharmaceuticals, Inc...today announced statistically significant positive topline results from its randomized Phase 2 study of oral TNF-α inhibitor, MYMD-1® in patients with chronic inflammation associated with sarcopenia, or age-related frailty. The study met its primary endpoints of significantly reducing chronic inflammatory markers in participants treated with MYMD-1....The study met both of its primary endpoints, significantly reducing serum levels of three biomarkers, TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03) and maintaining appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also achieved all secondary endpoints related to safety and tolerability. There were no treatment-related adverse events (AEs) or serious adverse events (SAEs) over the course of the study."

P2 data • Immunology • Sarcopenia

MyMD Pharmaceuticals to Hold Conference Call Today to Discuss Phase 2 Trial Results (Businesswire) - "MyMD Pharmaceuticals, Inc...announced statistically significant positive topline Phase 2 results for its next generation Oral TNF-α inhibitor MYMD-1 in Sarcopenia/Age-Related Frailty earlier this week. In conjunction with its release, the company also announced it will hold a conference call today, August 2nd, at 4:30pm ET to discuss the results."

P2 data • Immunology • Sarcopenia

MyMD Pharmaceuticals and Charles River Present Positive Data for Next Generation, Oral TNF-α Inhibitor MYMD-1 in Rheumatoid Arthritis (Businesswire) - "MyMD Pharmaceuticals, Inc...is presenting data from a preclinical study of investigational, oral TNF-α inhibitor MYMD-1® at the 2023 Society of Toxicology Annual Meeting (SOT) in Nashville, TN. Study results comparing MYMD-1 to placebo were very highly significant and showed MYMD-1 reduced histopathological changes and the severity of standard arthritis clinical trial measures. The study was designed to investigate the anti-inflammatory effects of MYMD-1® in a rheumatoid arthritis (RA) model that mimics features of arthritis in humans and included commonly used clinical arthritis endpoints....Disease severity (total composite score) was reduced by 47% with MYMD-1® at 450 mg/kg/day orally versus a 37% reduction for etanercept 10 mg/kg by subcutaneous injection (see attached graphs)."

Preclinical • Immunology • Rheumatoid Arthritis

Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: MyMD Pharmaceuticals, Inc. | Trial completion date: Dec 2022 ➔ Aug 2023 | Trial primary completion date: Nov 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Inflammation • Sarcopenia • IL6 • TNFRSF1A

MyMD Pharmaceuticals Announces Upcoming Presentation of Preclinical Rheumatoid Arthritis Data for Oral TNF-α Inhibitor MYMD-1® at the Society of Toxicology 2023 Annual Meeting (Businesswire) - "MyMD Pharmaceuticals, Inc...announced that preclinical data from a study, conducted in partnership with Charles River Laboratories International, Inc., has been accepted for presentation at the upcoming Society of Toxicology (SOT) 2023 Annual Meeting....MyMD plans to give guidance on the early-stage trials for rheumatoid arthritis (RA) as it develops."

Preclinical • Immunology • Rheumatoid Arthritis

MyMD Pharmaceuticals to Present Data on Oral TNF-a Inhibitor MYMD-1 at the British Society for Immunology (BSI) Congress 2022 (Businesswire) - P1 | N=32 | NCT05077865| Sponsor: MyMD Pharmaceuticals, Inc. | "MyMD Pharmaceuticals, Inc...is presenting data today at the 2022 British Society for Immunology (BSI) Congress in Liverpool, England. Results from preclinical and clinical studies showed that MYMD-1 was safe and well-tolerated in healthy subjects and significantly reduced inflammation in a mouse model....In a preclinical study, repeat oral administration to mice in a collagen antibody induced arthritis (CAIA) model at 450 mg/kg/day significantly reduced the clinical score and paw swelling when compared to the CAIA disease control. In-life results showed percent change of inflammation relative to control was reduced by 37% with MYMD-1 while reduction was 29% with etanercept at 10 mg/kg/day. In a clinical study of healthy adults, single daily oral 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."

P1 data • Preclinical • Immunology • Rheumatoid Arthritis

MyMD Pharmaceuticals Announces Upcoming Presentation of Late-Breaking Data for MYMD-1 at the 2022 British Society for Immunology (BSI) Congress (Businesswire) - "MyMD Pharmaceuticals, Inc...has been invited to present late-breaking data at the 2022 British Society for Immunology (BSI) Congress in Liverpool, England. Late-breaking abstract...is scheduled for poster presentation on December 6, 2022, at 6pm GMT. In addition to safety and pharmacology data, the presentation will include information on the anti-inflammatory effects of MYMD-1 in a collagen antibody induced arthritis (CAIA) model, which mimics features of arthritis in humans."

Preclinical • Immunology • Inflammation

A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects. (PubMed, Drug Res (Stuttg)) - "Isomyosamine will continue to be investigated in phase 2 clinical trials for the treatment of sarcopenia/frailty, hashimoto's thyroiditis and rheumatoid arthritis."

Journal • P1 data • PK/PD data • Cardiovascular • CNS Disorders • Endocrine Disorders • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • Sarcopenia • TNFA

MyMD Pharmaceuticals Announces Publication of Phase 1 Data for oral TNF-alpha Inhibitor MYMD-1 in Peer-Reviewed Journal Drug Research (GlobeNewswire) - P1 | N=32 | NCT05077865 | Sponsor: MyMD Pharmaceuticals, Inc. | "MyMD Pharmaceuticals, Inc...announced the publication of results from a Phase 1 study of oral tumor necrosis factor-alpha (TNF-α) inhibitor, MYMD-1® (Isomyosamine), in peer-reviewed journal, Drug Research. The randomized, double-blind, placebo-controlled study, intended to evaluate the safety, tolerability, and pharmacokinetic profile of MYMD-1 in healthy adults, found that single daily doses for 3 days and multiple daily doses for 6 days were safe and well tolerated in healthy subjects. The study used single daily doses of 150 mg, 300 mg, and 450 mg, respectively, and multiple daily doses of 600 mg. There were no new or unexpected safety findings and no clinically relevant or severe adverse events reported....MYMD-1 is currently being evaluated in Phase 2 studies for sarcopenia/frailty, a result of the aging process, with data expected in 4Q 2022."

P1 data • P2 data • Immunology • Sarcopenia

MyMD-1 improves health span and prolongs lifespan in old mice: A non-inferiority study to rapamycin. (PubMed, J Gerontol A Biol Sci Med Sci) - "In vivo, a longitudinal cohort of 54 C57BL/6 mice, 19-month-old at the start, was randomized to receive MyMD-1, high-dose (126 ppm) rapamycin, or low-dose (14 ppm) rapamycin plus metformin. Many were shared with rapamycin, but MyMD-1 was more active in the inhibition of pro-inflammatory and pro-fibrotic biomarkers. Overall, MyMD-1 emerges as a new compound that, even when begun at an advanced age, induces beneficial effects on health and lifespan by modulating inflammation and tissue remodeling."

Head-to-Head • Journal • Preclinical • Fibrosis • Immunology • Inflammation • IL17A • IL6 • TNFA

MyMD Pharmaceuticals to Collaborate with Bascom Palmer Eye Institute to Study MYMD-1 in Ophthalmic Conditions (Businesswire) - "MyMD Pharmaceuticals, Inc...announced today that it has entered into a material transfer agreement (MTA) with Bascom Palmer Eye Institute of Miami, Florida to collaborate on a pre-clinical study using MYMD-1® as a potential treatment for traumatic optic neuropathy (TON). The project is fully funded by Bascom Palmer Eye Institute."

Licensing / partnership • Immunology

"$MYMD MyMD Pharmaceuticals to Collaborate with Bascom Palmer Eye Institute to Study MYMD-1 in Ophthalmic Conditions https://t.co/3tegNspjPj" (@stock_titan)

Ophthalmology

MyMD Pharmaceuticals’ Lead Compound MYMD-1 Demonstrates Superior Anti-inflammatory Effects over Top-Selling Therapies in a Pivotal Preclinical Model of Rheumatoid Arthritis (Businesswire) - "MyMD Pharmaceuticals, Inc...today announced positive new preclinical study data demonstrating the potential effectiveness of MYMD-1 for the treatment of rheumatoid arthritis (RA). MYMD-1 demonstrated a significantly greater anti-inflammatory effect than current TNF-alpha inhibitors on the market, the top three of which represent an estimated $31 billion market (based on 2020 revenues). The comparative study of arthritis, using the CAIA model2, was conducted and analyzed by Charles River Laboratories International, a full-service contract research organization for drug discovery and development. Study results showed that MYMD-1 inhibited inflammation more effectively in the RA model by 30% and 70% of the top two marketed drugs, respectively."

Preclinical • Immunology • Rheumatoid Arthritis