Anthera pulls the plug on Sollpura after Phase 3 failure, shares plummet 84%
pharmafile | March 13, 2018 | News story | Manufacturing and Production, Research and Development | Anthera, Eli Lilly, Sollpura, pharma, trial failure
Anthera Pharmaceuticals has announced that it is to terminate development of its investigational pancreatic enzyme replacement therapy (PERT) Sollpura after it failed to meet its primary endpoint in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis.
In the Phase 3 trial, 140 patients with the condition were randomised to receive either Anthera’s product or Johnson & Johnson’s Porcine PERT drug Pancreaze (pancrelipase). Building upon the findings of a previous Phase 3 study, patients were given a 25% higher starting dose of Sollpura and more aggressive dose optimisations “based on clinical signs and symptoms of malabsorption” – 59% of the participants went on to have their dose further adjusted.
It was found that the therapy, which Anthera picked up from Eli Lilly in 2014, did not achieve the non-inferiority margin of the coefficient of fat absorption (CFA); while some patients saw an improvement in their CFA from baseline, the drugmaker reported that more patients responded negatively and saw a worsening of their CFA, with an average treatment difference of 14.3% from baseline. The drug did however achieve its secondary endpoint of the coefficient of nitrogen absorption (CNA).
The revelation proved almost fatal for the company’s stock, wiping up to 84% from its value. Anthera said it would be evaluating the full data outputs of the trial and would be exploring “all strategic alternatives”.
“We are greatly disappointed by the findings of the RESULT study,” commented Craig Thompson, President & CEO of Anthera. “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.”
Matt Fellows
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