Delving into the Latest Updates on Kadence Bio Ltd. with Synapse

Overview

AbstractObjectivesTo determine the efficacy and potency of purified alkaloids (KH-001, KH-002, KH-003, KH-004) derived from Sceletium tortuosum in the PCA-induced ejaculation rat model.MethodsMale Wistar rats received the following compounds intraperitoneally, shortly before anaesthesia and 1h before the induction of ejaculation with PCA (5 mg/kg): KH-001 (20 μg/kg - 20 mg/kg; n=12), KH-002 (20 mg/kg; n=12), KH-003 and KH-004 (10, 20 mg/kg; n=6) or aqueous vehicle (0.5% (w/v) methylcellulose; n=12). The proportion of ejaculating rats within a dose group, the latency to first ejaculation and physiological determinants of emission (seminal vesicle pressure (SVP)) and expulsion (bulbospongiosus (BS) muscle burst) were determined. Data describing latency to first ejaculation were described by Kaplan-Meier analysis, and statistical significance relative to vehicle-treatment was determined by Cox regression. SVP and BS muscle burst were analysed using Student’s t-test or one-way ANOVA.ResultsWhile KH-001 increased latency to first ejaculation in a dose-dependent fashion, with a minimum effective dose of 200μg/kg, no such effect was observed with the other tested kanna alkaloids up to 20mg/kg. SV contractions were significantly reduced by all alkaloids, with no effect on BS muscle burst.ConclusionsThese novel findings indicate the potential utility of KH-001 in the symptomatic treatment of premature ejaculation in humans. Interestingly, of the four alkaloids examined, delayed ejaculation was observed with only KH-001, indicating that the various kanna alkaloids tested have a differentiated pharmacological profile. Studies are underway to determine mechanism(s) of action, and the relationship between the pharmacodynamics and pharmacokinetics of kanna-derived alkaloids.Conflicts of InterestRG and MK are employees and shareholders of Kanna Health Ltd. LMNS, FRB, RP, NG, and TP are shareholders of Kanna Health Ltd. RP is an employee of Kanna Health US LLC.

1

News (Medical) associated with Kadence Bio Ltd.

16 Nov 2023

·www.prnewswire.com

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

LONDON, Nov. 16, 2023 /PRNewswire/ -- The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have approved Kanna Health's Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, to start participant enrollment in a Phase 1 first-in-human clinical trial investigating the Safety and Pharmacokinetics of KH-001 Besylate (KH-001) in Healthy Male Subjects. KH-001 is a unique, proprietary on-demand drug being developed as the first FDA-approved treatment for premature ejaculation. These regulatory approvals signify a potential breakthrough in the management of a widespread condition, impacting up to 20% of men and their partners worldwide. 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: [email protected]). Logo -

Drug ApprovalPhase 1IND

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Pipeline

Pipeline Snapshot as of 27 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

IND Approval

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