We are hardly two weeks into 2021, and shares of Relmada Therapeutics Inc. (RLMD) have gained 22% so far this year.
Relmada is a late-stage biotech company developing drugs to treat diseases of the central nervous system in an entirely new way. The lead drug candidate is REL-1017, a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels of particular importance in major depressive disorder while avoiding effects on those channels that are associated with normal physiological functions.
REL-1017, as an adjunctive treatment in major depressive disorder patients who have failed at least one prior treatment in current depression episode, has advanced into a phase III program. The phase III program consists of two-arm, placebo-controlled clinical trials, with the first phase III trial, dubbed RELIANCE I, having been initiated as recently as last month.
The second phase III trial, named RELIANCE II, is expected to begin in the first half of 2021. The primary endpoint to be evaluated in the two phase III trials will be the change from baseline on the Montgomery and Asberg Depression Rating Scale (MADRS) score at day-28 for REL-1017 compared to placebo.
The top-line results from RELIANCE I trial are anticipated in the first half of 2022.
Relmada also has plans to explore the potential of REL-1017 as a monotherapy in major depressive disorder and a phase II trial is expected to be initiated in the first half of this year, with results to be reported in the fourth quarter of 2021.
REL-1017, an enantiomer of racemic *methadone, is a new chemical entity. *Methadone is a synthetic opioid. However, REL-1017 has shown to have virtually no opioid activity at the expected therapeutic doses, according to the company.
The human abuse potential studies of REL-1017 are ongoing, with results expected next quarter (2Q, 2021). The human abuse potential studies helps to determine if the drug candidate demonstrates similar, greater, or lesser degree of abuse potential when compared to an active comparator and to placebo (Source: FDA).
According to the National Institute of Mental Health, an estimated 17.3 million adults are affected by major depressive disorder in the U.S. Standard anti-depressants can take 4-6 weeks to work, and have significant side-effects like sleep disturbance, sexual dysfunction, GI distress and weight gain, to name a few.
It is said that about 50%-66% of patients with depression do not fully recover on an antidepressant medication. Antidepressants like Cymbalta (Eli Lilly), Effexor (Pfizer), Pristiq (Pfizer), Zulresso (Sage), and Spravato (Johnson & Johnson) are the primary treatment options for major depressive disorder.
While most of the approved antidepressants take up to a month to show antidepressant activity Relamda’s REL-1017 has a faster onset of antidepressant activity, say only a few days. REL-1017 is also said to have a favorable safety and tolerability profile.
According to the company, REL-1017 has the potential to be the first oral single agent NMDAR antagonist approved for the adjunctive treatment of MDD.
The company had cash & cash equivalents of $123.1 million as of September 30, 2020.
A 1-for-4 reverse stock split was implemented by the company on September 30, 2019. The shares were uplisted to the Nasdaq Capital Market from the OTC on October 10, 2019.
As a mark of meeting certain financial and liquidity requirements and for satisfying corporate governance and disclosure requirements,the stock was uplisted to the Nasdaq Global Select Market on July 13, 2020.
RLMD has traded in a range of $23.25 to $54.00 in the last 1 year. The stock closed Tuesday’s trading at $39.28, up 12.04%.
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