MyMD touts next-gen TNFα inhibitor TNFα inhibitor for age-related inflammation

2023-07-31

临床结果临床2期

MyMD Pharmaceuticals on Monday reported that its oral TNFα inhibitor TNFα inhibitor MYMD-1 met the primary endpoints of a Phase II study in patients with chronic inflammation associated with sarcopenia. The company, whose shares jumped as much as 24% on the news, said MYMD-1 could become the first drug approved in the US for age-related frailty, which is tied to elevated levels of proinflammatory cytokines.

MyMD says that unlike other therapies, MYMD-1 is able to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but doesn't block it from doing its normal job of being a first responder to any routine type of moderate infection. "Sarcopenia can significantly affect people as they age, and there are currently no approved treatments for the condition," noted chief medical officer Chris Chapman, so "a selective, oral treatment that reduces TNF-α, and inflammation and does not require infusion or injection, would be a welcome advance."

The randomised Phase II study has an estimated enrolment of 40 participants aged 65 years or older with chronic inflammation associated with sarcopenia. Subjects were dosed to one of four weekly MYMD-1 dosing cohorts or placebo. Primary outcome measures included evaluating the effect on serum levels of sTNFR1, IL-6 and TNFα over 28 days of treatment.

Setting up move to Phase III

The company said MYMD-1 significantly reduced serum levels of all three inflammatory markers, and met all primary pharmacokinetic and secondary safety and tolerability endpoints across multiple doses. Full results from the study will be presented or published at a later date, the company said.

According to Chapman, the findings "support the unique advantages of MYMD-1 as the first oral, selective TNFα inhibitor TNFα inhibitor candidate and potential future treatment option for sarcopenia and other autoimmune conditions such as rheumatoid arthritis." The company said it plans to initiate discussions with the FDA aimed at advancing MYMD-1 into Phase III testing for sarcopenia.

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