Private, clinical-stage biopharmaceutical company Aisa Pharma, Inc. announced on Monday that it has received orphan drug designation from the US Food and Drug Administration (FDA) for its AISA-021(cilnidipine), a fourth-generation calcium channel antagonist.
The company is developing the product intended for the treatment of Systemic Sclerosis (SSc).
The product is a form of cilnidipine, a fourth-generation calcium channel blocker (CCB), distinguished from other dihydropyridine CCBs by its increased selectivity for the N-type calcium channel.
Andrew Sternlicht, MD, CEO and founder of Aisa Pharma, said, 'To our knowledge, this is the first time the FDA has granted orphan drug designation to a calcium channel antagonist for an autoimmune illness. We hope this designation will accelerate our development program for AISA-021, which is designed to provide a once-daily, well-tolerated, and economical treatment that we hope can improve the lives of patients with SSc. We are actively seeking a development partner and investors to support bringing this much-needed treatment to patients.'
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