FDA Accepts NDA for Investigational RA Agent

In August, the U.S. Food & Drug Administration (FDA) accepted an investigational new drug application for MYMD-1, an oral tumor necrosis factor (TNF) α inhibitor that crosses the blood-brain barrier. Currently in pre-clinical studies, MYMD-1 is designed to regulate the immune system by selectively blocking TNF-α when it becomes overactivated during a cytokine storm and in autoimmune diseases. However, the agent does not block TNF-α from its primary job of regulating inflammatory response.¹

Background

The investigational new drug application will evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of MYMD-1 for treating patients with active rheumatoid arthritis (RA). The currently available TNF-α inhibitors for RA and other autoimmune diseases, such as adalimumab, are administered by injection or intravenous infusion.² Therefore, if ever FDA approved, MYMD-1 would be easier to administer to patients than currently available treatments. MYMD-1 also exerts an anti-inflammatory effect by blocking interleukin (IL) 6.

To date, early clinical trials have not been associated with serious adverse events, but additional studies are still needed.

Other research: Recently, statistically significant results from a phase 2 study of MYMD-1 for treating patient with sarcopenia were released. Sarcopenia is an age-related decline in muscle mass and strength that leads to greater risk of hospitalization, disability and death. In the study, MYMD-1 lowered levels of TNF-α, IL-6 and soluble TNF receptor biomarkers and met all safety and tolerability end points.³

MYMD-1 is also being investigated for Hashimoto’s thyroiditis.³ Most studies for this agent are in early phases of clinical trials, so time will tell.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. News release: FDA accepts MyMD Pharmaceuticals’ investigational new drug application for phase 2 study of oral TNF-α inhibitor MYMD-1 in rheumatoid arthritis. MyMD Pharmaceuticals Inc. 2023 Aug 14.
2. Treatments: Tumor necrosis factor (TNF) inhibitors. American College of Rheumatology. 11 Sep 2023.
3. Our pipeline. MYMD Therapeutic Inc. 2023.