The company’s phase 2 trial in idiopathic hypersomnia yielded positive topline data, with the full results set for presentation at SLEEP 2024.


Summary: In Q1 2024, Zevra Therapeutics reported positive topline data from its phase 2 study of KP1077 in idiopathic hypersomnia, demonstrating promising tolerance and early signs of meaningful benefits. The full results will be presented at SLEEP 2024, and an end-of-phase 2 FDA meeting is planned for Q3. Net revenue for Q1 was $3.4 million.

Key Takeaways:

  • Zevra Therapeutics’ phase 2 study of KP1077 in idiopathic hypersomnia showed promising topline results, indicating the therapy is well-tolerated and offers potentially meaningful benefits.
  • The full data package from the completed phase 2 study will be presented at the SLEEP 2024 conference in early June.
  • Zevra is preparing for an end-of-phase 2 meeting with the FDA in Q3 to discuss the KP1077 program’s progress and next steps.

During the first quarter, Zevra Therapeutics made progress in executing its strategic objective to advance the KP1077 program in sleep disorders, according to Neil F. McFarlane, president and chief executive officer of Zevra, in a release.

In Q1, the company reported positive topline data from its placebo-controlled, double-blind, proof-of-concept phase 2 study of KP1077 in patients with idiopathic hypersomnia, which showed that it was well tolerated and demonstrated early signs of potentially differentiated and clinically meaningful benefits. 

The full data package from its completed phase 2 study will be presented at the upcoming SLEEP 2024 conference in early June.

The company is planning for an end-of-phase 2 meeting with the US Food and Drug Administration in the third quarter.

Overview of Q1 2024 Financial Results:

  • Net revenue for Q1 was $3.4 million, compared to net revenue of $3.2 million in Q1 2023. Research and development expenses were $12.3 million for Q1 2024, compared to $8.7 million in Q1 2023. 
  • The increase in research and development expenses was primarily driven by an increase in spending for the KP1077 phase 2 clinical trial that has since been completed.  
  • The company’s cash runway forecast includes the completion of the KP1077 development program for idiopathic hypersomnia.

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