A failure at Eli Lilly, the comeback drug teplizumab shows off more upbeat diabetes data in the run-up to an FDA filing
Provention Bio has some more positive data to add to its looming BLA for a new treatment designed to delay the onset of diabetes among patients.
Their new trial data for teplizumab boosted the average amount of time it takes for a patient to be diagnosed with type 1 diabetes to 5 years, adding a year to their earlier number compared to a steady 2 years for the placebo arm.
Researchers added that they are tracking clear evidence that the drug can stabilize and then reverse deteriorating C-peptide levels, “suggesting a delay in the destruction of beta cells and restoration of insulin production by dysfunctional beta cells. Importantly, even in those who advanced to clinical-stage T1D, treatment with teplizumab resulted in a slower decline in C-peptide levels compared to placebo.”
Patients selected for this study had declining C-peptide levels when they enrolled.
That was all music to the ears of its backers, as Provention’s shares $PRVB surged 9% on Monday.
Teplizumab is on a comeback trail, 10 years after Eli Lilly wrapped a failed development program and washed its hands of the whole thing. The brainchild of longtime investigator Jeffrey Bluestone, it’s thrived in the hands of Provention, picking up “breakthrough” status at the FDA as well as PRIME billing in Europe.
The licensing application is set up for a 4th quarter filing.
Social: Ashleigh Palmer, Provention Bio CEO (Third Pole via YouTube)