Mymd Pharmaceuticals Inc., the privately held developer of a synthetic derivative of tobacco alkaloids for the potential treatment of autoimmune diseases and age-related disorders, will soon list on Nasdaq via its acquisition of former point-of-care testing company Akers Biosciences Inc., shares of which (NASDAQ:AKER) climbed 29.1% to $2.22 on Nov. 12. The combined company, to be headquartered in Baltimore, will retain Mymd's name and adopt the trading symbol MYMD. Concurrent with the merger, Akers is raising $18 million in a private placement priced at-the-market.

Chris Chapman, chief medical officer of Mymd, called the merger "the natural next step" for his company. Furthermore, taking the company public will give it expanded access to capital to support robust phase II programs for its lead assets and attract high-level talent, he told BioWorld. Chapman will lead the combined company once the merger is complete.

Akers, of Thorofare, N.J., once sold disposable breathalyzer tests to measure blood alcohol levels and another test to detect an antibody causing allergic reaction to heparin. But, faced with persistent challenges in that business due to the pandemic, it ceased production of those products in July. Since March, it has been primarily focused on the development of a vaccine candidate against SARS-CoV-2 with Gurugram, India-based Premas Biotech Pvt Ltd. The future of that program post-merger has yet to be determined.

Following the combination, current Akers shareholders will own about 20% of the combined company, while current Mymd shareholders will own about 80%. The merger, which is expected to close in the first half of 2021 subject to shareholder approval, also provides for additional contingent payments in cash and shares to the stockholders of Mymd under certain circumstances.

A common tie

MYMD-1 (isomyosmine), the company's most advanced candidate, is an oral small molecule that inhibits production of tumor necrosis factor-alpha (TNF-alpha), a cell signaling protein involved in systemic inflammation. The company said it is the first of its type to cross the blood-brain barrier. A now-complete phase I study of the candidate in healthy volunteers has established its safety. Next, the company plans to begin two phase II trials testing it in the first quarter of 2021 followed by additional phase II studies throughout 2021.

The first of the phase II studies will evaluate MYMD-1 for the treatment of COVID-19 patients with depression at Johns Hopkins University, where Mymd's soon-to-be chief scientific officer, Adam Kaplin, founded the Neuropsychiatric CNS Autoimmune Consultation Clinic.

"The role of immune activation and inflammation in precipitating depression has been studied for 40 years," Chapman said. Increased concentrations of inflammatory biomarkers have even been found to "sabotage and circumvent the mechanisms of action of conventional antidepressants," according to one study.

Mymd has already generated preclinical evidence that MYMD-1 suppresses production of TNF-alpha, a key cytokine elevated in both people with depression and those who fare poorly with COVID-19. Now, in its phase II test of the candidate, its team hopes to blaze a new trail to treatment. The primary endpoint of the trial will be a biomarker: measuring TNF-alpha levels following treatment. Should they succeed, there could be plenty of customers in wait, in light of a recent finding that almost one in five survivors of COVID-19 get a diagnosis of a psychiatric disorder in the three months following a positive test for the SARS-CoV-2.

The second planned phase II study of MYMD-1 will be in sarcopenia, or age-related loss in skeletal muscle, which is associated with increasing inflammatory activity in the blood, including increased levels of TNF-alpha. "We think that we can go in and regulate the tumor necrosis factor-alpha and we can slow down the deterioration of the muscle in those patients over 65 to 70 years of age," Chapman said.

The company will continue to work on a second asset, SUPERA-1R, a synthetic derivative of cannabidiol that has demonstrated to effectively target CB2 receptors. It "addresses the unmet need for a synthetic CBD with enhanced bioavailability and potency so physicians may treat patients with an FDA-approved drug rather than botanicals that contain impurities," the company said. Potential applications of the candidate include anxiety, chronic pain and seizures, and it is expected to begin human trials as a therapy for epilepsy, followed by chronic pain.

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