Relmada Therapeutics (RLMD) HAP Data Significantly Improves Commercial Outlook - Analyst

Earlier today, Relmada Therapeutics, Inc. (NASDAQ: RLMD) announced top-line results of the human abuse potential (HAP) study with REL-1017 – a novel NMDA receptor (NMDAR) channel blocker and the company's lead candidate in Phase 3 development for the treatment major depressive disorder (MDD).

Top-line results showed that all three doses of REL-1017 (25 mg, 75 mg and 150 mg, the therapeutic, supratherapeutic and maximum tolerated doses, respectively) tested in recreational opioid users, demonstrated a highly statistically significant difference vs. the active control drug, oxycodone 40 mg.

The study's primary endpoint was a measure of "likability" with the subjects rating the maximum effect (or Emax) for Drug Liking "at the moment", using a 1=100 bipolar rating scale, with 100 as the highest likability, 50 as neutral (placebo-like), and 0 the highest dislike.

Truist Securities analyst Joon Lee, commenting on the newly released data believes it “Significantly Improves Commercial Outlook.”

She points to three key highlights:

• All REL-1017 doses fared better in likability than comparator/competitor
• In likability against placebo, “25mg and 75mg were indistinguishable from placebo while the highest dose of 150mg did exhibit some preference over placebo”
• KOLs in general viewed the separation from active comparator as the more important and the consensus view was that REL-1017 would likely be a schedule 4 or 5 drug if approved

The analyst notes that “actual likeabilty for 25mg, 75mg and 150mg all were at or slightly below the lower bound of our expectations implying REL-1017 may have even lower likeability than our model suggest.”

She believes such encouraging data positions the drug very well ahead of the upcoming HAP study against IV ketamine, as “KOLs on the call stated that likability for REL-1017 would be similar in other HAP studies as well. And that IV ketamine would show a likability score in excess of >>65. This implies that 25mg and 75mg will likely stat sig separate from IV ketamine.”

Truist is increasingly optimistic on the shares following the data release, as they reiterate the “Buy” rating and move up the price target to $90, from $75.

RLMD shares are currently trading flat.

Written by Vlad Schepkov | [email protected]

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