First non-hormonal menopause treatment approved for use in the UK by the MHRA, with early-stage development at Stevenage Bioscience Catalyst

• The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved elinzanetant (branded as Lynkuet™) for the treatment of moderate to severe hot flushes and night sweats associated with menopause. These symptoms, also known as vasomotor symptoms, affect a significant proportion of women and can have a considerable impact on quality of life.
• Elinzanetant is the first non-hormonal dual NK-1,3 antagonist treatment for menopause symptoms to receive regulatory approval anywhere in the world. It works by targeting neurokinin-1 and neurokinin-3 receptors, introducing a new class of therapy for managing these symptoms.
• The treatment was developed through Phase 2 by KaNDy Therapeutics, co-founded by Dr Mary Kerr and Dr Mike Trower while based at Stevenage Bioscience Catalyst (SBC).
• KaNDy was formed in 2017 as a spin-out from NeRRe Therapeutics, which remains based at SBC, and was acquired by Bayer in 2020. Bayer has since led the late-stage development, global regulatory submissions and commercialisation.

Dr Mary Kerr, CEO of NeRRe Therapeutics, Co-founder of KaNDy Therapeutics and member of the BioInnovation Institute’s Women’s Health Innovation Panel, said:

This is a real success story for SBC, UK Biotech and Women’s Health. The ex-KaNDy team are thrilled to have played a part in the development of elinzanetant. We are grateful to our Investors for their belief, to SBC for the excellent support, and Bayer for delivering a comprehensive Phase 3 data package to secure approval.

Women’s health has been chronically underfunded for decades. A recent McKinsey report concluded that closing the gender health gap could reduce the time women spend in poor health by almost two-thirds, and add up to US $1 trillion to the global economy by 2040.

Andrew Waters, CFO and Interim CEO, Stevenage Bioscience Catalyst, said:

We warmly congratulate Bayer on this important milestone. We also thank and acknowledge Dr Mary Kerr and Dr Mike Trower for their role in founding KaNDy Therapeutics and leading the early-stage development of elinzanetant here at SBC. It is a clear example of how collaboration between entrepreneurial scientists, investors and global industry can help move research closer to patients.

Read the MHRA Announcement: MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause - GOV.UK