Anthera saw its shares tank after hours as the biotech announced yet another failed study, this time for its late-stage trial for a GI candidate in cystic fibrosis patients.
Its med, known as Sollpura, was in a phase 3 test for cystic fibrosis patients with exocrine pancreatic insufficiency, an enzyme deficiency that hinders digestion, and was being tested on how well it can help CF patients absorb fat in a noninferiority trial.
But it said last night that Sollpura “narrowly missed” its primary endpoint, i.e., being not clinically worse than Janssen’s marketed med for the condition, known as Pancreaze, in the coefficient of fat absorption (CFA) measurement.
But with some data mining, or what the biotech calls “additional pre-specified analyses of CFA” (mITT-baseline observation carried forward and per protocol), Sollpura was then found to have met the noninferiority criterion.
Anthera also dug into the data and found that its drug’s ability to absorb protein was not clinically worse than Janssen’s drug.
This measurement, known as the coefficient of nitrogen absorption, measures protein digestion and absorption, and according to Anthera is a key requirement of its planned (and now delayed) FDA submission.
The biotech added that it would release more data from the extension phase of this study in the first few months of next year.
It blamed doing problems for missing its endpoint, saying that its data show that “Sollpura may have been under dosed versus the Pancreaze labeled dose.”
Given these glimmers of hope, the biotech aims to undertake another tweaked study of the med early next year.
“Anthera will initiate activities for an additional clinical study of Sollpura in patients with EPI due to cystic fibrosis, which Anthera expects will enable optimized dosing and dose titration,” the biotech said in a statement.
“Anthera believes that these modifications in the study design will allow patients to achieve the optimal level of fat absorption as measured by CFA,” it added.
The new study will begin in in the first quarter of 2017, with Anthera seeing only a “modest delay” in the filing of the BLA, which will now be “around Q1 2018.”
The markets however were not positive, and its shares fell 64% today on the news, which also came around a month after it posted a failed lupus study. It now has a market cap of just $30 million, with its shares worth just 72 cents.
This candidate, blisibimod, was being tested in systemic lupus erythematosus but failed to meet its primary endpoint based upon the SLE Responder Index-6 at 52 weeks. It follows a string of failed SLE trials from a number of biopharmas over the past three years.