Atai Life Sciences Shares Plunge as KUR-101’s Phase I Trial Efficacy Drops – ATAI Life Sciences (NASDAQ:ATAI)

today, Atai Life Sciences NV Atai released additional clinical data from Kures Therapeutics Phase 1 trial of KUR-101 in healthy volunteers. This two-part trial was designed to assess the safety, tolerability, pharmacokinetics and analgesic activity of KUR-101 – the company’s promising atypical opioid receptor modulator that aims to be an alternative to methadone-like drugs opioid use disorder (OUD). So far in this market session, the news has become a selling phenomenon as the tax loss selling season looms large towards the end of 2022.

Today we announced the results of the Kures Therapeutics Phase 1 Part 2 clinical trial of KUR-101, a novel derivative of mitragynine for potential treatment. #opioiduseddisorder cc @flowbrand @C_Angermayer @Allan_Malievsky Subject #mental health #Loudly

— Atai Life Sciences (@atai_life) December 23, 2022

Part 1 of the trial to establish the KUR-101 dosing range was successful. KUR-101 was well tolerated and produced dose-dependent analgesic activity without clinically significant effects on respiration at any dose-level tested (10mg, 20mg, 40mg, 60mg, 90mg) Was done – Comparator study including high end 90mg dosage level selected for Part 2.

However, part 2 of the study to evaluate the safety and analgesic activity of KUR-101 in comparison to both oxycodone and placebo appeared to disappoint on efficacy, where “the analgesic effect of KUR-101 was superior to that seen with oxycodone on both cold and pressure test (CPT) and thermal testing. Furthermore, both KUR-101 and oxycodone “demonstrated an effect on respiration comparable to placebo, thus precluding definitive conclusions of KUR-101’s respiratory effect.”

Although investors expected KUR-101 to demonstrate analgesic effects comparable to oxycodone — one of the most widely prescribed drugs for OUD — investors should take these early results in context.

Phase 1 trials are primarily designed to accumulate short-term safety (toxicity) and pharmacological data. Although initial efficacy can be addressed, it is considered a secondary endpoint. Because the number of patients is small and controls are absent, it is impossible to draw proper conclusions on any data set—especially efficacy.

In fact, Part 2 consisted of Atai’s randomized and double-blinded crossover study, in which only 18 healthy volunteers were enrolled and randomized to one of three sequences (6 subjects in each).

At the time of publication, Atai Life Sciences was trading at $2.72 per share, down 10.52% on the session.

This article was originally published on Dales Report and appears here with permission.

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