First non-hormonal menopause treatment in its class of drugs approved for use in the UK by the MHRA, with early-stage development at Stevenage Bioscience Catalyst
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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.
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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.
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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).
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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 Ltd, 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 here.
Dr Mike Trower (second left), Dr Mary Kerr (centre) and the KaNDy Therapeutics team who first moved into SBC in 2017.
Notes to editors
About Stevenage Bioscience Catalyst: Stevenage Bioscience Catalyst is a science park and innovation hub supporting early-stage therapeutics ventures. Since opening in 2012, companies based on the campus have raised over £4 billion to develop and commercialise new medicines. Located in the UK’s Golden Triangle and co-located with GSK, SBC provides lab and office space, mentoring and business support, alongside access to a collaborative community of researchers and investors. For more information, visit: www.stevenagecatalyst.com
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