Zevra’s CEO updates shareholders on recent milestones, including the completion of a phase 2 trial for idiopathic hypersomnia.

Summary: At SLEEP 2024, Zevra Therapeutics will present the full data from the KP1077 phase 2 trial for idiopathic hypersomnia, signaling potential advancements into phase 3 trials. A shareholder letter from CEO Neil McFarlane underscores this milestone, alongside notable company expansion. With a growing team and strategic focus on rare diseases, McFarlane says Zevra remains committed to delivering impactful therapies to those in need.

Key Takeaways:

  • Zevra Therapeutics will unveil comprehensive data from the KP1077 phase 2 trial for idiopathic hypersomnia at the SLEEP 2024 conference in June, indicating potential progress into phase 3 trials.
  • CEO Neil McFarlane’s shareholder letter highlights encouraging results for Azstarys in treating ADHD, which has also been show to improve sleep in children with ADHD.
  • Zevra’s strategic focus on rare diseases is evidenced by its commitment to delivering transformative therapies, supported by a growing team, according to McFarlane.

Zevra Therapeutics Inc, a rare disease therapeutics company, will present the full data package from the completed KP1077 phase 2 trial in idiopathic hypersomnia patients at the SLEEP 2024 conference in June, according to a letter issued to shareholders from Zevra’s president and CEO Neil McFarlane.

In the letter, McFarlane outlines recent business highlights, including the completion of the phase 2 study of KP1077 in patients with idiopathic hypersomnia. Zevra now is preparing to advance KP1077 into a potential phase 3 trial.

“We are encouraged by the results which show that KP1077 is well tolerated and demonstrates early signs of differentiated and meaningful clinical benefits…The study successfully fulfilled the objectives of providing key information needed for the design of a potentially pivotal efficacy trial,” says McFarlane in the letter. “We plan to request an end-of-phase 2 meeting with the FDA to seek guidance on the phase 3 clinical trial design and are optimistic about the potential of KP1077 to address unmet needs in sleep disorders.”

Other Business Highlights

The CEO says the company also “remain[s] encouraged” by the ongoing royalty and milestone contributions from Azstarys for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients age 6 years and up, which is being commercialized by Zevra’s partner, Corium Inc.

Azstarys was shown in a study published in Frontiers in Psychiatry to also have statistically significant and lasting improvements in children’s sleep. The drug was approved by the US Food and Drug Administration in 2021 for the treatment of ADHD symptoms in people aged 6 and older.

Additionally, McFarlane highlighted growth within the company. “Since we first announced our strategic objective of becoming a leading rare disease company in the first half of 2022, we have seen significant growth in the size of our team. Through our recruiting efforts, and by virtue of our acquisitions, we have grown from a team of 24 employees to a current team of 81,” he says in the letter. 

This growth includes building out customer-facing commercial and medical affairs teams with experience in rare diseases and the addition of Adrian Quartel, MD, as chief medical officer. 

“The pace of Zevra’s transformation has been tremendous, and I am proud of how much progress we have made. However, there is much more to do,” he says in the letter. “From the combined strength of three teams with diverse experiences and backgrounds, we have become One Zevra, fully focused and dedicated to our mission of bringing life-changing therapeutics to people living with rare disease.”

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