MyMD Pharmaceuticals has announced that all clinical trial sites commenced participant enrolment for the Phase II clinical trial of its lead drug candidate, MYMD-1, as a therapy to delay aging and expand healthy lifespan.
An immune-metabolic system regulator, MYMD-1 has been designed to regulate the release of inflammatory cytokines. It was originally developed for autoimmune diseases.
The main purpose of the therapy is to prevent sarcopenia and frailty, slow the aging process, and extend healthy lifespan.
The placebo controlled, multi-centre, double-blind, randomised Phase II study is designed to evaluate the tolerability, efficacy, and pharmacokinetics of MYMD-1 to treat people aged 65 years or above with chronic inflammation associated with sarcopenia/frailty.
MyMD president, director, and chief medical officer Chris Chapman said: “As agreed upon with the FDA, the main goal, or primary endpoint, of our Phase 2 multi-centre study is to demonstrate reduced levels of TNF-alpha (TNF-α), a key player in associated pathological aging, in the blood of patients.
“Having already demonstrated the drug’s mechanism of action and efficacy in Phase I where we achieved the same primary endpoint as our current trial, we are pleased with the progress in Phase II to date.
“With all trial sites now enrolling patients, we expect the pace of enrolment to speed up over the next several months.”
The company expects efficacy data in the second half of this year.
In the Phase I dose-ranging study, which evaluated MYMD-1 to delay aging, participants were treated with the therapy or placebo.
TNF-α levels were measured pre- and post-treatment in the study.
Findings showed that a significant decrease in TNF-α levels was observed in subjects treated with MYMD-1.