Medherant's Testosterone Patch Shows Promise in Phase 1 Trial for Menopausal Women
核心洞察
Medherant (搜索)'s TEPI Patch (搜索) successfully restored testosterone blood levels to normal pre-menopausal ranges in post-menopausal women during Phase 1 clinical testing at Hammersmith Medicines Research (搜索) in London.
The innovative transdermal patch technology offers superior comfort and adhesion compared to existing hormone delivery methods, addressing a significant unmet need in menopause (搜索) treatment.
The company has received regulatory approval from MHRA and Research Ethics Committee to proceed with a multiple-dose pharmacokinetic study targeting hypoactive sexual desire disorder (搜索) in post-menopausal women.
Warwick spin-out Medherant (搜索) has reported positive results from its Phase 1 clinical trial of the TEPI Patch (搜索), an innovative testosterone delivery system designed specifically for post-menopausal women. The study, conducted at Hammersmith Medicines Research (搜索) in London, demonstrated that the patch effectively restored testosterone blood levels to the normal range seen in pre-menopausal women.
The clinical-stage company's proprietary transdermal technology addresses a significant gap in menopause (搜索) hormone therapy options. According to Karolina Afors, Medherant (搜索)'s Medical Director, "These latest results represent another major step in the development of the testosterone TEPI Patch (搜索) to address a significant condition faced by many post-menopausal women. Our patch technology will provide women with a superior treatment option for testosterone as part of menopause hormone therapy."
Advanced Patch Technology Offers Superior Comfort
The TEPI Patch (搜索) incorporates a proprietary adhesive system that provides unprecedented comfort, tolerability and adhesion. Unlike existing hormone delivery methods, the patch is well-tolerated, leaves no residue, and maintains flexibility and comfort during normal daily activities. This represents a significant advancement over current options such as gels and creams, which can provide poor dose control.
David Haddleton, Chief Scientific Officer at Medherant (搜索) and Professor in the Department of Chemistry at the University of Warwick, emphasized the technology's potential: "The success of this initial trial paves the way for our upcoming multiple-dose study which will start dosing before the end of the year. We remain committed to accelerating development to bring the testosterone TEPI Patch (搜索) to market swiftly and to deliver the adhesion and comfort that women deserve."
Regulatory Approval for Next Phase Study
Medherant (搜索) has secured approval from both the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee for its Clinical Trial Application for the next Phase 1 multiple-dose pharmacokinetic study. This follow-up study will focus on developing the patch as a treatment for hypoactive sexual desire disorder (搜索) - distressing low libido - in post-menopausal women.
The company has also obtained scientific advice from both the MHRA and the Swedish Medical Products Agency to inform its regulatory strategy for product registration in the UK and European Union markets.
Addressing Unmet Medical Need
Despite recommendations in the NICE Menopause (搜索) Guidelines and the Global Consensus Position Statement on the Use of Testosterone Therapy for Women, there is currently no approved testosterone patch product specifically designed for women. This regulatory gap represents a significant unmet medical need in menopause care.
Transdermal delivery offers distinct advantages over oral hormone administration by avoiding spikes in drug levels that can lead to side effects and providing better dose control compared to topical gels and creams. The patch format also offers superior convenience and compliance compared to other delivery methods.
Company Development and Partnerships
Founded in 2014, Medherant (搜索) is developing a new generation of medicinal patch technologies beyond its lead testosterone product. The company has established collaborative partnerships with pharmaceutical companies, including a development collaboration agreement announced in March 2024 with Bayer to create a patch product for an already-approved oral medicine.
The positive Phase 1 results position Medherant (搜索) to advance its lead program toward potential market entry, addressing a significant therapeutic area with limited treatment options for post-menopausal women seeking hormone therapy alternatives.