KemPharm is creating KP1077 as a lead SDX candidate for continual sleep disorders

KemPharm Inc km/h has selected KP1077 for idiopathic hypersomnia (IH) as its lead serdex methylphenidate (SDX) candidate in the pipeline.

  • Idiopathic hypersomnia is a rare disorder that results in chronic excessive daytime sleepiness.
  • CEO Travis C. Mickle announced in a letter to shareholders that the company plans to submit an Investigational New Drug (IND) for KP1077 to IH by mid-2022.
  • A Phase 2 study is expected to begin in Q3 2022, with top-line data expected in Q2 2023.
  • A parallel program for KP1077 in narcolepsy is also planned, with IND filing expected in the second half of 2022.
  • A phase 2/3 study is expected to start in late 2022 or early 2023.
  • The Company announced that while KP1077 is its lead SDX candidate, it plans to pursue the of KP879 as an extended duration agonist replacement therapy for Stimulant Use Disorders (SUD).
  • However, the company recognized that KP879 would require a more demanding and lengthy development program that will likely require a partnership to successfully advance the program to regulatory approval.
  • KemPharm had $127.8 million in cash and cash equivalents at the end of 2021.
  • Available capital and projected earnings will extend the cash runway to at least 2025.
  • The company plans to reach full staffing by the end of January 2022 for the commercial launch of Azstarys, an FDA-approved therapy for attention-deficit hyperactivity disorder (ADHD).
  • The company also noted that Azstarys has access to more than 100 million commercial and Medicaid patient lives.
  • Price promotion: KMPH shares close at $7.68 on Wednesday.

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