BridgeBio says it's undeterred after Truseltiq partner withdraws application, discontinues drug

Last year, BridgeBio was riding high on back-to-back FDA approvals, including for cancer treatment Truseltiq. At the time, Helsinn Group wanted a piece of the pie and inked a deal worth up to $2.45 billion to split commercialization rights on the med.

All seemed well, until an SEC filing from late September revealed that Helsinn is terminating the arrangement, citing "commercial considerations." The disclosure also affected LianBio, which has rights to the medicine in China, Hong Kong and Macau.

A more recent SEC filing from LianBio reads like a game of telephone, with BridgeBio informing LianBio that Helsinn is discontinuing the drug.

That left BridgeBio to inform LianBio that it intends to close its ongoing global phase 3 trial of Truseltiq in first-line cholangiocarcinoma. In turn, LianBio has stopped its own activities relating to the trial and is ending its pursuit of selling the drug in China.  

Still, LianBio said its own filing that it will continue to support patients who are currently being treated with the drug. The company will continue its phase 2a proof-of-concept trial in certain patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Helsinn decided to discontinue the drug because it concluded that ongoing distribution is not “commercially reasonable," BridgeBio said in a Thursday statement to Fierce Pharma. The move doesn’t impact BridgeBio's development of Truseltiq for achondroplasia, a form of dwarfism.

If proven in the rare disease, the drug could challenge BioMarin’s Voxzogo, an FDA-approved treatment for achondroplasia.

BridgeBio licensed Truseltiq from Novartis in early 2018 with plans to pursue its development in bile cancers and dwarfism. The medicine won FDA approval last year as a targeted metastatic bile duct cancer treatment based on results from a single-arm phase 2 study in 108 patients.

Previously, BridgeBio spun out its affiliate QED Therapeutics to tackle Truseltiq development with $65 million in seed funding.