KemPharm To Develop KP1077 As Lead SDX Candidate For Chronic Sleep Disorder

KemPharm Inc 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.