Anthera has seen its fair share of setbacks over the years, and today that tally only got longer, as it cut loose its failed late-stage Lilly castoff Sollpura (liprotamase), and now seeks those dreaded “strategic alternatives.”
It’s been a rough ride for a drug that was outlicensed by Lilly back in 2014, and the writing appeared to be on the wall when, back in December 2016, it posted data from its phase 3 Solution test for cystic fibrosis patients with exocrine pancreatic insufficiency, an enzyme deficiency that hinders digestion.
It was being tested on how well it can help CF patients absorb fat in a noninferiority trial, but Sollpura “narrowly missed” its primary endpoint: 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 called “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 was a key requirement of its planned (but long-since delayed) FDA submission.
Cue another late-stage test, known as Result (and aimed to help prop up Solution), which included a higher starting dose and “more aggressive dose optimizations based on clinical signs and symptoms of malabsorption.”
Today the Result was in, but it was a loss: “Sollpura did not achieve the primary endpoint of the coefficient of fat absorption; Sollpura did achieve the secondary endpoint of coefficient of nitrogen absorption; Further development of Sollpura to be discontinued,” the PR read in a swift breakdown.
Sollpura had guided back in late 2016 for its BLA to be submitted to the FDA in Q1 of this year, but now it’s ended up on the scrap heap.
“We are greatly disappointed by the findings of the Result study,” said Craig Thompson, president and CEO. “We would like to extend our deepest gratitude to the patients and their families, study investigators, and the cystic fibrosis community for the support they have provided in the clinical development of Sollpura.”
The company too is now under pressure and announced “plans to evaluate all strategic alternatives in order to maximize shareholder value,” with more info coming down the line.
Anthera's other experimental med, blisibimod, was being tested in systemic lupus erythematosus but failed a few years back to meet its primary endpoint based upon the SLE Responder Index-6 at 52 weeks.
Shares of Anthera plunged more than 80% premarket, taking it into penny stock territory.