RiverVest managing directors John McKearn and Niall O’Donnell uncovered two late-stage drug programs deprioritized by Pfizer and Sanofi. Entering licensing discussions, John and Niall dug into the existing clinical data and interviewed disease experts to formulate a plan to treat life-threatening pediatric and adult liver diseases caused by genetic and autoimmune disorders.

RiverVest partnered with Pappas Capital venture partner Mike Grey, an experienced pharmaceutical executive and serial entrepreneur, to create Lumena with headquarters in San Diego. John joined the board of directors while 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 in Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis (PFIC). Alagille and PFIC are two severe genetic diseases that cause intense itching and impaired growth and quality of life, often resulting in children requiring liver transplants in order to reach adulthood. Lumena aimed to address this and other diseases with a novel oral drug.

It has been the most rewarding experience of my life working with the RiverVest team to build Lumena and bring an important medicine to children with life-threatening diseases.

Mike Grey, Board Chairman, Mirium Pharmaceuticals

In 2013, Lumena hired Ciara Kennedy, a long-term colleague of Niall, as chief operating officer, to execute on the clinical programs. In 2014, with the clinical studies nearing completion, Lumena began exploring the potential for an initial public offering (IPO). Prior to the potential IPO, Shire stepped in to acquire Lumena, ultimately returning $400 million to Lumena investors. The lead Lumena asset, maralixibat, subsequently demonstrated safety and efficacy in children with Alagille Syndrome and PFIC, gaining breakthrough designation from the FDA. Maralixibat, now in the hands of Mirum Pharmaceuticals (a RiverVest Fund IV company), will be submitted for FDA approval in 2021.

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