An FDA panel’s decision to reject the obesity drug lorcaserin shouldn’t affect Athersys Inc.’s (NASDAQ: ATHX) development of a similar drug, the Cleveland-based company’s chief executive said.
Athersys is developing an anti-obesity drug that focuses on the same receptor as Arena Pharmaceuticals’ lorcaserin, which was rejected by a U.S. Food and Drug Administration panel due to concerns the drug didn’t work well and had potential safety problems.
Athersys CEO Gil Van Bokkelen told FierceBiotech that the decision “was a reflection of some compound specific issues they see with Lorcaserin and the approach Arena took in development. Other than helping to clarify what their standards are, I don’t think it has major ramifications for obesity drug development.”
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Athersys investors no doubt hope that’s more than wishful thinking on Van Bokkelen’s part, and it may very well be. Athersys’ obesity drug, which is still in the preclinical stage, “has shown significantly more receptivity to the 5HT2C receptor” and could be more efficacious than lorcaserin based on comparative preclinical studies, FierceBiotech reported.
Lorcaserin is designed to mimic the effect of the brain chemical serotonin and suppress patients’ appetites. The panel expressed concern that the drug appeared to cause tumors in rats.
“The decision should incentivize people to listen to the input from the FDA and design their pivotal studies very carefully,” Van Bokkelen said. “We try to listen to the agency very carefully and incorporate what they tell us early on, which I’ve always believed is the right approach.”
Athersys is further along in developing a stem cell therapy for heart attacks than it is a drug for obesity. In July, the company reported positive results from a small Phase 1 study of its MultiStem therapy in treating heart attack patients. MultiStem is a stem cell therapy derived from the bone marrow of adults. Some analysts think MultiStem has the potential to change the way heart attack patients are treated.
