Ironwood Pharmaceuticals has advanced plans to build out its pipeline, securing a chance to license Cour Pharmaceuticals’ liver disease candidate CNP-104 after getting a look at early-phase data.
Having stopped development of two prospects in quick succession, Ironwood began the year with a void where its pipeline used to be. Ironwood’s management set out to address the situation, putting construction of a pipeline of innovative treatments for serious gastrointestinal diseases at the center of its strategy for the company.
The focus has manifested in a deal with Cour. Ironwood will pay Cour around $20 million in upfront and near-term fees associated with a phase 1 clinical trial of CNP-104. If Ironwood likes the phase 1 data, it can license the drug in return for a financial package that could ultimately total $475 million.
Cour secured clearance from the FDA to start a phase 1 clinical trial of CNP-104 last month, leading it to aim to initiate studies before the end of the year. The move into the clinic will provide an early test of an approach that is a departure from existing ways of managing primary biliary cholangitis, a liver disease that is currently treated with drugs including ursodeoxycholic acid and Intercept’s Ocaliva.
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CNP-104 consists of PDC-E2 encapsulated in a biodegradable nanoparticle. Autoimmunity to PDC-E2 is a driver of the disease. By administering CNP-104, Cour aims to induce immune tolerance to PDC-E2 and thereby address the cause of primary biliary cholangitis.
The program builds on Cour’s Takeda-partnered CNP-101, which has shown clinical promise as a way to induce gluten-specific tolerance in celiac disease. Both candidates are products of a platform designed to present disease-specific antigens to the T cells that drive inflammation and immune dysfunction, thereby reprogramming the cells to address the cause of the disease.