Drug Development

In back-to-back failures, Anthera’s CF drug Sollpura falls short in PhIII, shares crater (again)

Six weeks after Anthera $ANTH suffered a failed Phase III study for its lupus drug blisibimod, the small biotech was forced to concede that its late-stage non-inferiority study for its cystic fibrosis drug Sollpura also flopped.

Held out as Anthera’s best chance at bouncing back in 2017, Sollpura failed to hit the primary endpoint on non-inferiority for change in the Coefficient of Fat Absorption, or CFA. The company added that the drug hit the goal in a per protocol analysis — factoring in only the patients who completed the study — and also hit on a Coefficient of Nitrogen Absorption.

The plan now is to mount a new study and shoot for a BLA in early 2018, betting that modifying the study with “flexibility to adjust their Sollpura dose based upon malabsorption symptoms at any time during the study” will set the stage for success.

Investors, though, weren’t in the mood for renewed hope. Anthera’s shares plunged 63% on the news.

This is a drug with multiple failures to contend with. Eli Lilly tried the pancreatic enzyme replacement therapy liprotomase in a Phase III and failed in 2011. Anthera acquired the drug in 2014. It is designed to treat low digestive enzyme levels, or Exocrine Pancreatic Insufficiency, caused by CF.

Just a few weeks ago Anthera said it was promoting J. Craig Thompson to CEO and Paul Truex to executive chairman to supposedly prep for a commercial launch of this drug. And despite the latest setback, Anthera still isn’t ready to walk away.

“The study data suggest that the deficiency in fat absorption may be addressed by small changes in study design, including more liberal dose adjustment.  A need for alternative treatments remains for EPI patients who are unable to maintain appropriate nutritional health, especially those who seek soluble or non-porcine therapeutic options” said Michael Konstan, MD, Vice Dean for Translational Research at Case Western Reserve University School of Medicine.

A couple of weeks ago Jefferies’ Matthew Andrews laid out a case for success here that is likely going to feed into the backlash Tuesday evening.

We believe the Ph. III study has a high likelihood of success based on its non-inferiority design, a well-controlled patient population enrolled in the study (potential for less variability in efficacy), improved formulation (higher lipase dose), and weight-based dosing (vs. fixed dosing in the prior Lilly-sponsored Ph. III study). The study has successfully passed two safety reviews by the data monitoring board.


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