MyMD recently announced positive topline Phase 2 study results in participants with sarcopenia/frailty which showed MYMD-1 demonstrated statistical significance in reducing serum levels of TNF-, IL-6 and sTNFR1, biomarkers common to a number of chronic inflammatory diseases, and met all primary pharmacokinetic and secondary safety and tolerability endpoints across multiple doses over 28 days of treatment. New key findings from the Phase 2 study showed that cohort 4 (1050mg) showed a reduction in TNF-, a key cytokine, across 28 days versus placebo (p=0.002 to 0.008).
'The scientific data clearly indicate statistical significance across 28 days at the high dose group and we are extremely excited about the completion of the phase 2 clinical trial,' said Dr.
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The Company will present the clinical safety report to the FDA with plans to seek future guidance for a Phase 3 clinical trial in sarcopenia. If approved, MYMD-1 has the potential to be the first drug approved by FDA for the condition, an age-related decline in muscle mass and physical function which leads to greater risk of hospitalization, disability, and death.
MyMD also recently announced that the
MYMD-1 is an oral, next-generation TNF- inhibitor with the potential to transform the way TNF- based diseases are treated due to its selectivity and ability to cross the blood brain barrier. 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 also been shown to selectively block TNF- action where it is overactivated without preventing it from doing its normal job of responding to routine infection. In addition, in early clinical studies it has not been associated with serious side effects known to occur with traditional immunosuppressive therapies that treat inflammation.
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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
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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
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Email: rschatz@mymd.com
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