Momenta Pharmaceuticals has been hit with a setback. The Cambridge, MA-based biotech says that its Phase II study matching the experimental necuparanib with Abraxane and gemcitabine failed to make an appreciable dent in metastatic pancreatic cancer.
At the halfway point of the study, with 57 deaths, the data monitoring committee decided that they weren’t seeing any evidence that the drug was making a significant difference for patients. Now they’re shutting the study down and unblinding the data to see what the next best step will be for the patients who are left.
Momenta’s research team had hoped that they had designed a drug that would skirt the kind of anti-coagulation issues that have plagued predecessors, while maintaining the anti-tumor punch. The biotech says that they did not identify any serious safety issues.
Momenta’s shares $MNTA slid 6% on the news Thursday morning. The biotech has been pursuing new biosimilars, with a near term readout expected for its knockoff of Humira. Its collaboration with Baxalta has been picked up by Shire now and Momenta is also working with Mylan on other programs as well.
“We are extremely disappointed with the outcome of the futility analysis – in particular, for those patients with pancreatic cancer where there is still so much unmet need for safe and effective therapy,” said Jim Roach, the chief medical officer at Momenta, in a statement. “We agree with the DSMB recommendations and plan to confirm the futility analysis and determine next steps for the necuparanib program.”
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