Kanna Health announces FDA and MHRA approvals to begin its Phase 1 clinical trial for the development of KH-001 as first FDA-approved treatment for premature ejaculation

The Phase 1 study will be conducted in the UK by Simbec-Orion, an experienced full-service Contract Research Organization (CRO). The Phase 1 study will be conducted in the UK by Simbec-Orion, an experienced full-service Contract Research Organization (CRO). DrRyan Protzko, Kanna Health's President, stated:"Our clinical trial approval on both sides of the Atlantic represents a critical milestone as we officially become a clinical stage company. The study marks the start of a journey...

The Phase 1 study will be conducted in the UK by Simbec-Orion, an experienced full-service Contract Research Organization (CRO).

Dr Ryan Protzko, Kanna Health's President, stated: "Our clinical trial approval on both sides of the Atlantic represents a critical milestone as we officially become a clinical stage company. The study marks the start of a journey towards understanding the therapeutic potential of KH-001 in humans, in cooperation with regulatory bodies in our priority markets."

"This approval allows Kanna Health to advance our understanding of how KH-001 may provide patients with a potentially transformative therapy, where no drug treatments are approved in the US and few treatment options exist worldwide", said Dr Hans-Juergen Gruss, Kanna Health's Chief Medical Officer.

About Premature Ejaculation

Premature ejaculation is the most common form of male sexual dysfunction, impacting ~20% of men (Shindel AW, Althof SE, Carrier S et al.: Disorders of Ejaculation: An AUA/SMSNA Guideline. J Urol 2022), with its most severe form characterized by ejaculation within 1 minute of penetration (~3% of men). Premature ejaculation is associated with secondary psychological effects, with 65% of patients reporting personal distress as a result 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 therapeutics for sexual and mental health conditions.

Further information:

For further information, please contact John Boghossian (email: john@kanna.health).

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