PulmoSIM Therapeutics Granted Orphan Drug Designation for PT001 by the FDA to Treat Pulmonary Arterial Hypertension

PulmoSIM Therapeutics (PulmoSIM), the pharmaceutical subsidiary of VeriSIM Life, Inc., is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for asset PT001 for the treatment of Pulmonary Arterial Hypertension (PAH). PT001 targets multiple responsible pathways in PAH, to provide a more efficacious curative treatment.

The FDA’s Office of Orphan Products Development (OOPD) grants orphan drug designation to support the development of medicines for rare disorders that affect fewer than 200,000 people in the United States. Orphan drug designation will allow PulmoSIM to be eligible for a seven-year period of U.S. marketing exclusivity upon approval of PT001, a waiver of the Prescription Drug User Fee Act (PDUFA) filing fees, and tax credits in clinical research expenses along with regulatory and strategic assistance.

“We’re thrilled that the FDA has granted this designation for PT001, and look forward to advancing this drug candidate into a clinical trial program very soon,” said Dr. Jo Varshney, DVM, PhD, CEO and Founder at PulmoSIM. “PAH is a devastating disease, and there still remains a high unmet need for more effective and less-burdensome treatment options for patients living with PAH. Leveraging VeriSIM Life’s Virtual Drug Development Engine, BIOiSIM, we will be fast-tracking development of curative therapeutics for rare diseases with highly unmet needs.”

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