MyMD Pharmaceuticals, Inc. - MYMD STOCK NEWS

MyMD Pharmaceuticals plans to share positive phase 2 study results for MYMD-1 in sarcopenia at BioFuture 2023 Meeting. The study showed a reduction in TNF-α levels in cohort 4 (1050mg) compared to placebo (p=0.002 to 0.008). MYMD-1 has potential as the first FDA-approved drug for sarcopenia. The FDA has accepted the IND for MYMD-1 in rheumatoid arthritis.

MyMD Pharmaceuticals, Inc. has received FDA acceptance of its Investigational New Drug Application for MYMD-1, an oral TNF-α inhibitor, to evaluate its safety and efficacy in patients with active rheumatoid arthritis (RA). MYMD-1 has the potential to transform the treatment of TNF-α based diseases due to its selectivity and ability to cross the blood-brain barrier. It can be taken orally, unlike currently available TNF-α inhibitors that require injection or infusion. MYMD-1 has shown to block both TNF-α and IL-6 activity, making it doubly effective at inhibiting inflammation. The Phase 2 study in sarcopenia showed promising biomarker data, and the company plans to initiate Phase 3 trials. If approved, MYMD-1 could be the first drug approved for sarcopenia.

MyMD Pharmaceuticals announces positive Phase 2 results for MYMD-1 in Sarcopenia/Age-Related Frailty

MyMD Pharmaceuticals, Inc. (MYMD) announced positive topline results from its Phase 2 study of MYMD-1, a potential oral TNF-α inhibitor for chronic inflammation associated with sarcopenia. The study demonstrated significant reduction in inflammatory markers and met all safety and tolerability endpoints. MYMD-1 has the potential to be the first FDA-approved drug for sarcopenia, a condition linked to increased risk of hospitalization, disability, and death.

MyMD Pharmaceuticals (Nasdaq: MYMD) recently announced a dosing update for its Phase 2 clinical trial of MYMD-1®, a potential treatment for chronic inflammation caused by sarcopenia and frailty in elderly patients. The trial has successfully dosed 37 out of 40 patients, with no reported safety or toxicity issues among the first 30 patients. The company is progressing into the final cohort of the study, having randomized patients into escalating dose groups. Sarcopenia affects 5-50% of older adults, with no FDA-approved treatments currently available. The aging disorders market is projected to exceed $600 billion by 2025, with TNF-alpha blockers generating approximately $40 billion in annual revenue. MYMD-1® is designed to cross the blood-brain barrier and may offer innovative solutions for aging-related diseases.

MyMD Pharmaceuticals (Nasdaq: MYMD) announced significant preclinical results for its investigational, oral TNF-α inhibitor, MYMD-1^®, at the Society of Toxicology Annual Meeting. The study demonstrated that MYMD-1^® significantly reduced histopathological changes and arthritis severity metrics compared to placebo, with reductions of 47% in disease severity versus 37% for etanercept. MYMD-1^® is noted for its oral administration and ability to cross the blood-brain barrier, positioning it as a promising candidate for rheumatoid arthritis treatment. MyMD is planning early-stage trials and will provide further program guidance.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) has joined the LOT Network, aimed at protecting against patent assertion entities (PAEs) litigation. This strategic move is designed to safeguard MyMD's intellectual property and resources, allowing the company to focus on its clinical development programs. The LOT Network, comprising over 2,800 companies, provides protection against frivolous lawsuits, which numbered 2,289 in 2022 with an average defense cost of $4 million. MyMD's lead candidate, MYMD-1®, is a promising TNF-alpha inhibitor targeting autoimmune diseases, while its Supera-CBD™ offers potential in managing addiction and pain.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) announced that the U.S. Drug Enforcement Administration (DEA) has determined that its investigational cannabinoid Supera-CBD™ will not be classified as a controlled substance during development. This significant ruling allows enhanced flexibility in drug development for Supera-CBD, a synthetic analogue of CBD, which is 8000 times more potent as a CB2 agonist compared to plant-based CBD. Supera-CBD is undergoing preclinical pain studies in collaboration with Johns Hopkins Medicine, showing promise for managing conditions like addiction, anxiety, and chronic pain.

MyMD Pharmaceuticals (Nasdaq: MYMD) announced that preclinical data for MYMD-1 has been accepted for presentation at the Society of Toxicology 2023 Annual Meeting. The study, focusing on MYMD-1's anti-inflammatory effects compared to Enbrel, will be presented on March 20, 2023, at 9:00 AM CT. MYMD-1 is an oral TNF-α inhibitor showing potential for treating rheumatoid arthritis, a condition affecting approximately 1.5 million people in the U.S. The company is also advancing MYMD-1 through a Phase 2 study for sarcopenia. MyMD is committed to innovating treatments for autoimmune and inflammatory diseases.