KemPharm Inc (NASDAQ:KMPH) has selected KP1077 for idiopathic hypersomnia (IH) as its lead serdexmethylphenidate (SDX) candidate in the pipeline.
- Idiopathic hypersomnia is an uncommon sleep disorder resulting in chronic excessive daytime sleepiness.
- Issuing a letter to shareholders, CEO Travis C. Mickle said that the Company plans to submit an Investigational New Drug (IND) for KP1077 in IH by mid-2022.
- A Phase 2 study is expected to begin in Q3 2022, with topline data anticipated by Q2 2023.
- A parallel development program for KP1077 in narcolepsy is also on the cards, with IND filing expected in H2 2022.
- A Phase 2/3 trial is on track to begin by the end of 2022 or early 2023.
- The Company said that while KP1077 is its lead SDX development candidate, it plans to continue the development of KP879 as an extended-duration, agonist replacement therapy for Stimulant Use Disorder (SUD).
- However, the Company recognized that KP879 would require a more challenging and lengthier development program that will likely necessitate partnership to advance the program toward approval successfully.
- KemPharm held cash & cash equivalents of $127.8 million at the end of 2021.
- The available capital and projected revenue will extend the cash runway through at least 2025.
- For the commercial rollout of Azstarys, FDA-approved therapy for attention deficit hyperactivity disorder (ADHD), the Company said that it plans to achieve full staffing by the end of January 2022.
- The Company also noted that Azstarys has payor access to more than 100 million commercial and Medicaid patient lives.
- Price Action: KMPH shares are closed at $7.68 on Wednesday.
