Relmada Therapeutics Inc (OTCMKTS:RLMD) announced that it obtained Health Canada Clearance to continue dose escalation and evaluate higher doses of d-Methadone, the company’s NMDA receptor antagonist being formulated for the treatment of neuropathic pain.
Relmada stated that in the Phase I pharmacokinetic and pharmacodynamic trial in healthy volunteers not initially exposed to opioid therapy, REL-1017 showed a good safety profile with lack of dose-limiting side effects. The original four cohorts were administered with increasingly higher doses. The study will continue dose-escalation with more number of cohorts.
The expert view
Sergio Traversa, the Chief Executive Officer of Relmada, said that the first four cohorts of the Phase I trial successfully showed no dose limiting side effects given with d-Methadone. It was applicable even when given at doses higher than conventionally administered with racemic methadone in opioid naïve enrollments which support the completely varied pharmacological profile of the compound. Racemic methadone is a known synthetic opioid to treat both drug and pain addiction. However, it suffers from poor tolerability and safety due to opioid side effects.
The objective of the initial Phase I trial is to assess the tolerability, safety, pharmacokinetics and pharmacodynamics and of oral single increasing doses of REL-1017 in healthy enrollments in order to achieve a Maximum Tolerated Dose. In a planned second trial, healthy enrollments will get daily doses of the product for multiple days, based on the defined MTD. The data from key trials will inform the design of a succeeding Phase II proof of concept trial in neuropathic pain. As a single isomer, REL-1017 has been demonstrated to have NMDA antagonist properties.
In last trading session, the share price of Relmada Therapeutics surged more than 5% to close the trading session at $2.68. The gains came at a share volume of 133, 676 lower than the average volume of 241,246.