By Colin Kellaher
MyMD Pharmaceuticals announced today the positive topline results from a Phase 2 study of its lead product candidate, MYMD-1. This study focused on patients with chronic inflammation associated with sarcopenia, which is age-related frailty.
Meeting Primary Endpoints
The Baltimore clinical-stage pharmaceutical company revealed that MYMD-1 had successfully met both of its primary endpoints. It notably caused a significant reduction in serum levels of three biomarkers. Furthermore, the drug effectively maintained appropriate plasma concentrations and parameters during pharmacokinetic evaluations.
Secondary Endpoints Achieved
In addition to meeting the primary endpoints, MYMD Pharmaceuticals reported that the study also achieved all secondary endpoints related to safety and tolerability. Importantly, there were no treatment-related adverse events or serious adverse events throughout the trial.
Taking Steps Towards Phase 3 Study
Encouraged by these positive results, MyMD Pharmaceuticals intends to engage in discussions with the U.S. Food and Drug Administration (FDA) about conducting a Phase 3 study of MYMD-1. If successful, MYMD-1 could potentially become the first FDA-approved drug for sarcopenia. This condition, characterized by an age-related decline in physical function, significantly increases the risk of hospitalization, disability, and mortality.
Trading Halt Announcement
Today, trading in shares of MyMD Pharmaceuticals was halted premarket. The stock closed at $1.10 on Friday.