- Momenta Pharmaceuticals has decided to end development of necuparanib, an experimental drug for advanced pancreatic cancer and the biotech's lead clinical candidate, according to a regulatory filing submitted Thursday.
- Enrollment in a Phase 2 trial testing necuparanib in combination with Celgene's Abraxane was halted earlier this month after an independent data safety monitoring board concluded treatment didn't demonstrate a sufficient level of efficacy.
- Momenta markets two generic drugs, and is testing a biosimilar version of AbbVie's Humira in partnership with Baxalta (now Shire). Necuparanib, however, was the Cambridge, Massachusetts-based company's most advanced novel drug.
In the planned interim futility analysis revealed earlier in August, the data safety board concluded necuparanib "did not show a sufficient level of efficacy to warrant continued enrollment." No new toxicities were observed, but the board recommended Momenta unblind data from the trial to determine next steps.
According to a Form 8-K filed Thursday, Momenta confirmed the futility analysis done by the data safety board and discontinued work on necuparanib.
Pancreatic cancer is a particularly tough cancer to treat and a number of other companies have failed in their efforts to develop an effective treatment. In February, Incyte halted trials of its drug Jakafi in solid tumors, after a Phase 3 study in pancreatic cancer failed to show efficacy.
And this past May saw pancreatic cancer immunotherapies from NewLink Genetics and Aduro Biotech fall short of goal in Phase 3 and Phase 2b trials, respectively.
Momenta will now have to turn to its three other developmental drugs, all of which are in early stages. Most of Momenta's current revenues come from sales of Glatopa, which is marketed by Sandoz.
As of June 30, Momenta had $337 million in cash and equivalents, and forecast a burn rate of $40 to $45 million per quarter through the end of the year.