-Kanna Health announces FDA and MHRA approvals to begin its Phase 1 clinical trial for the development of KH-001 as the first FDA-approved treatment for premature ejaculation
LONDON, Nov. 16, 2023 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the Investigational New Drug (IND) application. and Kanna Health’s Clinical Trial Application (CTA), respectively, to initiate participant enrollment in a Phase 1, first-in-human clinical trial investigating the safety and pharmacokinetics of KH-001 Besylate (KH-001) in male subjects healthy.
KH-001 is a unique, patented on-demand drug that is being developed as the first FDA-approved treatment for premature ejaculation. These regulatory approvals signify a potential breakthrough in the treatment of a widespread condition that affects up to 20% of men and their partners worldwide.
The Phase 1 study will be conducted in the UK by Simbec-Orion, a contract research organization (CRO) with full-service expertise.
Dr. Ryan Protzko, President of Kanna Health, said, “The approval of our clinical trial on both sides of the Atlantic represents a critical milestone as we officially become a clinical-stage company. The study marks the beginning of a journey toward understanding the therapeutic potential of KH-001 in humans, in cooperation with the regulatory bodies of our priority markets.
“This approval allows Kanna Health to advance our understanding of how KH-001 can provide patients with a potentially transformative therapy, where there are no approved drug treatments in the United States and few treatment options exist worldwide,” said Dr. Hans-Juergen Gruss, director of Kanna Health. medical director.
Acerca de Premature Ejaculation
Premature ejaculation is the most common form of male sexual dysfunction, affecting approximately 20% of men (Shindel AW, Althof SE, Carrier S et al.: Disorders of Ejaculation: An AUA/SMSNA Guideline. J Urol 2022), its most severe form being characterized by ejaculation within 1 minute of penetration (~3% of men). Premature ejaculation is associated with psychological side effects, with 65% of patients reporting personal distress including anxiety, depression, low self-esteem and a negative impact on relationships.
About Kanna Health Ltd
Kanna Health is a clinical-stage biopharmaceutical company developing novel, fast-acting small molecule therapies for sexual and mental health conditions.
More information:
For more information, contact John Boghossian (email: john@kanna.health).
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