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FDA fast-track designation granted for type 1 diabetes treatment

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The FDA granted a Fast Track designation to Caladrius Biosciences Inc. for its product candidate CLBS03 for the treatment of type 1 diabetes, according to a press release.

The drug previously received an Orphan Drug designation from the FDA and an Advanced Therapeutic Medicinal Product classification from the European Medicines Agency. CLBS03 is currently being tested in a phase 2 clinical trial, The Sanford Project: T-Rex Study; the trial is expected to complete enrollment of the first cohort within the coming weeks.

The drug uses Tregs to treat autoimmune diseases caused by imbalances in an individual’s immune system. CLBS03 is expected to enhance Treg cell number and function. When Treg cells function properly only harmful materials are attacked by the T effector cells. The drug consists of patient’s own Tregs that have been expanded in number and enhanced for function.

“Obtaining Fast Track designation is a key milestone in our regulatory and development strategy for CLBS03,” David J. Mazzo, PhD, chief executive officer of Caladrius, said in a press release. “It underscores the great needs for innovative treatments, such as CLBS03, in the treatment of [type 1 diabetes] and allows for the acceleration of its development. We are making excellent progress advancing the U.S.-based phase 2 clinical program of CLBS03 to treat [type 1 diabetes] and look to complete enrollment of the first cohort of 18 patients in the coming weeks. This, coupled with our Orphan Drug and Fast Track designations, should make CLBS03 an even more attractive opportunity for a potential partner.”