MyMD enjoys stock bump as drug shows promise against age-related inflammation in phase 2 trial
31 Jul 2023
Clinical ResultPhase 2Phase 3
Preview
Source: FierceBiotech
Sarcopenia is linked to elevated levels of proinflammatory cytokines, the company said.
MyMD Pharmaceuticals’ lead asset has hit all primary and secondary endpoints in a mid-stage study of age-related inflammation, setting the company up to begin phase 3 talks with the FDA.
The study aimed to enroll 40 participants aged 65 years and older with chronic inflammation associated with sarcopenia—a term for the age-related progressive loss of muscle mass and strength. Over 28 days, they received weekly doses of either 600 mg, 750 mg, 900 mg or 1050 mg of the TNF-α inhibitorTNF-α inhibitor, dubbed MYMD-1, or placebo.
In a Monday morning release, the company reported that the drug hit both of the trial’s primary endpoints: significantly reducing serum levels of the biomarkers TNF-α, sTNFR1 and IL-6; as well as maintaining appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also hit all of its secondary endpoints, which related to safety and tolerability with no treatment-related adverse events reported.
Investors seemed pleased with the results, sending the company’s stock up 22% to $1.34 per share in the opening hour of trading Monday from a Friday close of $1.09.
Sarcopenia is linked to elevated levels of proinflammatory cytokines, the company noted in the release, hence the focus on biomarkers like TNF-α, a pro-inflammatory agent.
Based on the findings, MyMD—which merged with Akers Biosciences in 2021—now plans to open discussions with the FDA regarding a phase 3 study of MYMD-1 in sarcopenia.
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