TNF Pharmaceuticals is set to initiate fully funded mid-stage Phase II clinical trials of its lead programme, MYMD-1, targeting sarcopenia.
MYMD-1, a small molecule therapy, has shown positive results in regulating the immuno-metabolic system by blocking TNF-alpha activity.
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The upcoming studies aim to build on the positive results from an earlier Phase II trial, which demonstrated MYMD-1’s efficacy in reducing chronic inflammation markers in sarcopenia / frailty.
TNF Pharmaceuticals president and chief medical officer Mitchell Glass said: “In our view, MYMD-1, if approved, could be the first orally administered TNF-alpha inhibitor drug and the first and only therapy for sarcopenia, a common age-related disorder that causes a prolonged decline in physical function.
“As we prepare for our next fully funded clinical studies in sarcopenia/frailty, we also have open INDs for Phase II trials of MYMD-1 in two additional chronic inflammatory conditions, rheumatoid arthritis (RA) and Hashimoto’s thyroiditis, which we could pursue with the support of non-dilutive domestic and/or international development partnerships.
“A partner outside of the US could potentially help us accelerate the timeline to commercialisation of our lead asset.”
MYMD-1 targets TNF-alpha, a key protein in inflammation and autoimmunity.
A small Phase II study that was concluded last year showed that it significantly reduced serum levels of chronic inflammatory markers, without any treatment-related adverse events.
The drug’s ability to cross the blood-brain barrier also positions it as a potential treatment for rheumatoid arthritis and Hashimoto’s thyroiditis.
MYMD-1’s reduction of inflammation biomarkers, including TNF-α, sTNFR1, and IL-6, marks a significant step forward in addressing sarcopenia.
TNF Pharmaceuticals also has a secondary drug platform, Supera-CBD, a synthetic CBD analogue.
Supera-CBD is being developed for pain, epilepsy, anxiety and depression, and potentially opioid addiction treatment, given its binding profile with opioid receptors.
