MyMD Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to begin a Phase II clinical trial of oral MYMD-1 to treat rheumatoid arthritis (RA).
RA is a systemic inflammatory disorder, which causes chronic inflammation of the joints and impacts around 1.5 million Americans.
MYMD-1, a TNF-α inhibitor, is designed as a small molecule, allowing it to cross the blood-brain barrier and access the central nervous system.
Created for treating autoimmune diseases, it primarily aims to decelerate the ageing process, prevent sarcopenia and frailty, and prolong a healthy lifespan.
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The company is currently in the planning stages for the trial launch, scheduled for the first quarter of next year.
The placebo-controlled and randomised trial is anticipated to enrol around 60 patients with active RA. Patients will be given 1050mg of the drug through oral dosing.
MyMD president, director, and chief medical officer Chris Chapman said: “With the FDA’s recent clearance of our IND in RA, we are moving forward with plans to initiate a Phase II trial within the next several months.
“Results from preclinical studies have demonstrated MYMD-1’s potential to treat RA, and we believe this drug could one day be a disruptor in the massive market for similar treatments.”
In a preclinical study, the TNF-α inhibitor was demonstrated to significantly reduce swelling and other clinical arthritis measures compared to the broadly used therapy Enbrel (etanercept) for RA.
In June last year, MyMD announced that all clinical trial sites commenced participant enrolment for the Phase II study of MYMD-1 as a therapy to delay ageing.