Formation Bio has acquired the worldwide rights, excluding Greater China, to FHND5032, an oral, small-molecule miR-124 activator being developed for the treatment of autoimmune diseases.
The asset will be housed within Formation’s newly formed subsidiary Kenmare Bio, with plans to enter the clinic in 2026.
FHND5032 is designed to activate miR-124, an anti-inflammatory microRNA whose levels are reduced in multiple inflammatory diseases.
By activating miR-124, FHND5032 targets key immune drivers of inflammation, with the potential to provide durable control of chronic autoimmune diseases, an area of substantial unmet medical need.
Its oral formulation may offer patients a more convenient approach to long-term disease management.
Formation Bio is utilising its proprietary AI-driven clinical development platform, Forge, to fast-track and optimise the development of FHND5032 in a range of autoimmune diseases. Forge analyses precedent data and regulatory guidance to inform indication selection and biomarker identification, outlining the optimal development strategy.
Under the terms of the agreement, CTFH will receive a minority equity stake in Kenmare Bio, plus an upfront payment and additional development, regulatory, and commercial milestones totalling up to $500 million US dollars, as well as royalties on potential future sales. The acquisition adds to Formation Bio’s growing pipeline of assets.
