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news.Alizyme has reported that the FDA has agreed to the remaining two protocols for its Phase III development program for cetilistat under the special protocol assessment procedure and recommended that Alizyme open a separate diabetes investigational new drug application or IND.
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Following successful end of Phase II discussions, FDA has approved the company’s outline plan for the Phase III clinical development program of cetilistat.
This development plan comprises three 12 month studies involving, obese patients without co-morbidities and obese patients with treated or untreated co-morbidities (other than type 2 diabetes), obese patients without co-morbidities and obese patients with untreated co-morbidities (other than type 2 diabetes), and obese patients with treated type 2 diabetes and who may have treated or untreated other co-morbidities.
FDA has corresponded directly with company in relation to its planned Phase III program and recommended a separate diabetes IND for cetilistat, in order for the drug to be considered for a stand alone diabetes indication.