Expanding KP1077’s Clinical Program to Address Narcolepsy and Other Conditions: Christal Mickle

Author(s):

The cofounder and chief product development officer of Zevra Therapeutics talked about the phase 1 clinical trial of KP1077 for narcolepsy and potentially using it to treat other conditions. [WATCH TIME: 5 minutes]

WATCH TIME: 5 minutes

“The biggest thing with this study is it is will help us inform study designs for future research. We are looking for the appropriate dosing regimen [of KP1077] and what will work best for patients with narcolepsy.”

KP1077 is an oral treatment comprised solely of serdexmethylphenidate (SDX) which is used to treat ADHD. In recent news, SDX is currently being evaluated in a phase 2 clinical trial (NCT05668754) for the treatment of idiopathic hypersomnia (IH), a chronic neurological sleep disorder. In May 2022, Zevra Therapeutics filed an Investigational New Drug (IND) application for KP1077 as a treatment for IH, with the trial starting months later. The company received confirmation during a preIND meeting with the FDA that additional nonclinical studies were not needed to advance the treatment into clinical development because of the abundance of data currently available on SDX.¹

If successful, findings from the trial may warrant a phase 3 study in IH, as well as a potential trial investigating the therapy in narcolepsy. In recent news, the company announced that it is seeking authorization from the agency through an IND submission to begin a phase 1 clinical program of KP1077 in narcolepsy. Once the IND is cleared by the FDA, the company plans to start several phase 1 clinical trials of KP1077 as early as the second quarter of 2023.

Recently, Christal Mickle, cofounder and chief product development officer of Zevra Therapeutics, sat down with NeurologyLive® in an interview to discuss the plan for the phase 1 trial for narcolepsy. She provided information on the trial, including the methods, measurements, and time period for the study. She also spoke about the impact KP1077 can potentially have on patients with narcolepsy, as well as previous research on the treatment for other conditions.