RiverVest co-founded and seed funded Lumena and built a clinical strategy to fast-track its lead drug compound through clinical trials.
RiverVest Managing Director Niall O’Donnell developed rapid proof-of-concept clinical programs and led interactions with U.S. and European regulatory bodies. RiverVest’s John McKearn joined Lumena’s board of directors and Niall became acting chief medical officer.
Drawing on deep scientific expertise and relationships, the Lumena team tackled a significant unmet need and paved the way for safe, effective oral treatments for life-threatening liver diseases. Lumena was acquired by Shire less than 3 years after formation, delivering ~$400 million to investors. The story continues with Mirum.
Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC) are severe genetic diseases affecting 4,500 children in the U.S. and U.K. Most children with these diseases suffer from debilitating itching that disrupts sleep, stunts growth, and compels them to scratch themselves sometimes to the bone. The toll this takes on the psychological and social well-being of these children and their families is devastating. Many will require biliary diversion surgery or liver transplantation. Others will die from liver failure.
Niall O’Donnell on RiverVest putting patients first
A New Way of Looking at a Deprioritized Drug
Lumena was built upon a clinical-stage, cholesterol-busting drug candidate developed while RiverVest Managing Director John McKearn was head of discovery research at Searle. The compound was deprioritized by Searle/Pharmacia (now Pfizer), but had been proven safe and stable and ripe for a new clinical proposal.
Niall O’Donnell and entrepreneur Mike Grey worked backward to define their clinical focus; first understanding the problem the compound could solve (lowering high levels of bile acids) and then identifying a rare disease in which to solve that problem (cholestatic liver disease).
- Co-founded by RiverVest
- Acquired by Shire in 2014
- Delivered ~$400 million to investors
- Re-acquired by Mirum in 2019
Key members of the Lumena team who went on to co-found Mirum were Mike Grey, Niall O’Donnell, Ciara Kennedy, Susan Dubé, and Alex Dorenbaum.
Also notable were the deep connections forged with the Alagille Syndrome Alliance and the ALGS families as well as the creation of a “Lumena Pay-it-Forward” database, which became the foundation for the groundbreaking Global ALagille Alliance (GALA) Study.
Niall dug into the science and developed the clinical plans while I assumed the role of CEO. This marked the beginning of a partnership that spans six early-stage biopharma companies … and counting!