The study met its primary endpoints of significantly reducing chronic inflammatory markers in participants treated with MYMD-1. MYMD-1 has the potential to be the first drug approved by the
The study met both of its primary endpoints, significantly reducing serum levels of three biomarkers, TNF- (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03) and maintaining appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also achieved all secondary endpoints related to safety and tolerability. There were no treatment-related adverse events (AEs) or serious adverse events (SAEs) over the course of the study.
'We are very excited about these results indicating MYMD-1 demonstrated statistically significant reductions in all three inflammatory markers and met all additional pharmacokinetic and safety endpoints needed to advance our sarcopenia clinical program, with guidance from the FDA,' said
The Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) was designed to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in participants aged 65 years or older with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines. Patients in the study were dosed weekly with MYMD-1 or placebo over a 28-day period. The study consisted of four dosing cohorts versus placebo.
'We are encouraged by the reduction of inflammatory markers along with the favorable safety profile demonstrated in this study of an oral TNF- inhibitor,' continued
Full results from the study will be presented or published at a later date to be determined. The company plans to initiate discussions with the FDA regarding a Phase 3 study of MYMD-1 in sarcopenia.
About MYMD-1
MYMD-1, a next generation, oral selective inhibitor of tumor necrosis factor-alpha (TNF-), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Its ease of oral dosing is a significant differentiator compared to currently available TNF- inhibitors, all of which require delivery by injection or infusion.
MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF- when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. In addition, it has not been shown to cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.
About
MyMD's second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. The
Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance, or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'may,' 'plan,' 'will,' 'would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD's ability to, obtain and maintain regulatory approvals for clinical trials of MyMD's pharmaceutical candidates; the timing and results of MyMD's planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD's ability to retain and attract senior management and other key employees; MyMD's ability to quickly and effectively respond to new technological developments; MyMD's ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD's proprietary rights and the impact of the COVID-19 pandemic or similar public health emergencies on MyMD's results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended
Contact:
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Email: rschatz@mymd.com
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