RiverVest leverages a unique innovation network to find and cultivate compelling investment opportunities. We invest in products with a known path to clinical approval, doing our due diligence to assess markets, viability, and regulatory hurdles. Here’s how this deal came together.
In 2009, Ted Greene, CEO of Satiogen Pharmaceuticals, called longtime colleague RiverVest Managing Director John McKearn about a LDL cholesterol-targeting compound developed during John’s tenure as head of discovery research at Searle/Pharmacia (now Pfizer). Ted believed the compound could be effective as a bile acid reuptake inhibitor, which could potentially induce weight loss and correct type 2 diabetes.
RiverVest Managing Director Niall O’Donnell joined John in diving into this hypothesis under Mike Grey, an experienced pharmaceutical executive, serial entrepreneur, and venture partner at Pappas Ventures, who licensed technologies from Satiogen and formed Lumena with seed funding from Pappas and RiverVest.
Urgent Unmet Medical Need
While diabetes was, and may still be, an exciting opportunity for this mechanism, the team identified an urgent, unmet medical need: children with rare, life-threatening pediatric liver diseases. Niall began building a fast-track strategy for the clinical trials to get these children and their families the relief they needed.
An estimated 4,500 children in the U.S. and U.K. are diagnosed with Alagille syndrome (ALGS) and Progressive familial intrahepatic cholestasis (PFIC), which cause excruciating itching, failure to thrive, and for many, the need for liver transplant in order to reach adulthood. The lead Lumena asset, LUM001 (maralixibat), offered hope for these children and their families.
John joined Lumena’s board of directors and Niall became acting chief medical officer, helping guide the company through interactions with U.S. and European regulatory bodies and develop rapid proof-of-concept clinical programs. Ciara Kennedy, a long-time colleague of Niall, was brought in as chief operating officer to execute the clinical programs.
Just as clinical studies were nearing completion and Lumena began exploring the potential for an initial public offering (IPO), Shire offered to acquire the company, returning ~$400 million to Lumena investors. Maralixibat, now in the hands of Mirum Pharmaceuticals (a RiverVest Fund IV company), received FDA approval in September 2021 for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older.
The story continues with Mirum.