Company: Kadence Bio

Location: London

Founded: 2021

Founders: John Boghossian, Dr Ryan Protzko, Lars Wilde, Manon Veraart

Written by: Laura Castillo De Franca

Edited by: Natasha Barrow & Caroline Babisz

Innovation Summary

Kadence Bio (formerly Kanna Health) is a clinical-stage drug development company pioneering new treatments for sexual health. Their lead asset, KH-001, is being developed as the first FDA-approved treatment for premature ejaculation. The company recently completed a Phase I clinical trial and is planning to initiate Phase II trials next year. Their pipeline focuses on the development of rapid-acting and safe treatments for acute mood disorders. The team includes repeat founders and scientists, and the Board features senior pharma executives including the current global Chief Medical Officer at GSK and the former head of sales and marketing for Viagra at Pfizer.

History and Challenges

At its inception, Kadence Bio founders investigated various potential treatments for mood disorders, exploring different classes of alkaloid small molecules. They discovered a compound with a distinctive pharmacokinetic profile and an unexpected effect: delayed

ejaculation. No FDA-approved treatments exist for premature ejaculation, a condition affecting at least 1 in 20 men and their partners globally. Recognising this significant unmet need in the pharmaceutical market, the founders built on the discovery to create Kadence Bio, with their lead asset in development for premature ejaculation.

Kadence Bio has faced social challenges in addressing the stigma around premature ejaculation. To overcome this, they implemented anonymous surveys, creating a safe space for men to share their experiences and concerns without fear of judgement.

On the regulatory front, Kadence Bio has also faced hurdles due to the rigorous safety standards required for drug approval. Since premature ejaculation affects a large population and is not life-threatening, significant side effects could deter usage. In response, Kadence Bio has focused their research on demonstrating that their drug is as or more effective while being safer and more convenient than current treatment options for human use, such as Antidepressants.

Vision and Progress

Kadence Bio is dedicated to cultivating sexual and mental wellbeing. Their mission is to develop innovative therapeutics that address critical unmet needs in sexual and mental health. With their lead asset, KH-001, they aim to bridge what they call the “intimacy gap” - the large disparity between men and women in time taken to reach climax (3x to 10x). They are passionate about this because premature ejaculation affects more than 100 million men worldwide, along with their female and other-gendered partners. This condition often leads to secondary issues such as low self-esteem, stress, anxiety, and depression.

The Future

In 2023, Kadence Bio opened an Investigational New Drug (IND) application with the FDA in the US and obtained clinical trial approval from the MHRA in the UK. They have completed dosing in their first-in-human Phase I clinical trial investigating the safety and pharmacokinetics for KH-001, for which a patent has been granted by the United States Patent and Trademark Office. Their Phase II proof-of-concept efficacy trials are planned to begin in 2025.

In the coming years, their primary goal is to complete clinical trials and bring this potentially groundbreaking drug to market. The roadmap is not unlike that of Viagra, which at the turn of the century revolutionised treatment for erectile dysfunction, the other large male sexual dysfunction. Alongside this, they aim to foster open conversations around sexual and mental health with both partners. Looking ahead, Kadence Bio plans to develop further therapeutics to address acute mood disorders that currently lack safe and effective treatments.

If you would like to learn more about Kadence Bio, please visit www.kadencebio.com or email info@kadencebio.com

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