LivaNova Misses Primary Endpoint in RECOVER Clinical Study

LivaNova’s VNS Therapy did not meet the primary endpoint in a study to see its effectiveness in helping unipolar patients suffering from treatment-resistant depression.

The London-based company provided an update on its RECOVER Clinical Study earlier this week. LivaNova said while the study did not meet its primary endpoint, statistical significance was achieved in select secondary endpoints.

The PE measured the difference between active and sham VNS Therapy on the rate of Montgomery–Åsberg Depression Rating Scale (MADRS) response for the unipolar patient cohort with a predetermined p-value of p<0.023. Over 12 months, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from the treatment arm’s baseline.

Due to a strong response in the sham group, which was unforeseen in the study design, statistical separation between the treatment and sham arms for the PE was not achieved by the end of the study. Despite this, the totality of data supports a meaningful treatment effect for those who received active VNS Therapy particularly given that the RECOVER unipolar patient population has a significant unmet need after having failed numerous other treatment modalities.

During an earnings call in May, LivaNova’s CEO Vladimir Makatsaria spoke about the importance of the results and what they could mean going forward.

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“It's obviously the outcome of the RECOVER trial is a very important milestone for us, because I mean not only it will, more importantly, make some opportunities potentially available for patients, but also will kind of determine the direction of our strategy on this one,” Makatsaria said during a call according to a Seeking Alpha Transcript. “So, it's an important milestone.”

He gave further clarity in prepared remarks after the data were revealed.

“Despite not achieving statistical significance for the primary endpoint for the unipolar cohort in the RECOVER study, the effect of active VNS Therapy was within our expectations and resulted in clinically meaningful benefits in select secondary endpoints. We are conducting an in-depth analysis of the data with key stakeholders and will determine the path forward in the coming weeks."

The company said it expects to publish the unipolar cohort data, including details on the PE and secondary endpoints, in peer-reviewed journals in 4Q24. Importantly, no safety issues were reported.