Tranquis Therapeutics Granted FDA Orphan Drug Designation for TQS-168 for the Treatment of Amyotrophic Lateral Sclerosis
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Tuesday, June 21, 2022
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Tranquis Therapeutics, Inc., a clinical stage immuno-neurology company developing innovative medicines with the potential to revolutionize the management of neurodegenerative and aging-related diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for TQS-168, a small molecule modulator of PGC-1a, for the treatment of amyotrophic lateral sclerosis (ALS).
Key Points:
- Tranquis Therapeutics, Inc., a clinical stage immuno-neurology company developing innovative medicines with the potential to revolutionize the management of neurodegenerative and aging-related diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for TQS-168, a small molecule modulator of PGC-1a, for the treatment of amyotrophic lateral sclerosis (ALS).
- Tranquis expects to begin a Phase 2 study of TQS-168 in people living with ALS by the end of 2022.
- The FDAs Office of Orphan Drug Products grants orphan status to drugs and biologics that demonstrate promise for the treatment of diseases or conditions affecting fewer than 200,000 people in the United States.
- Orphan drug designation provides Tranquis with certain development incentives, including tax credits for qualified clinical trials, exemptions from FDA user fees, and the potential for seven years of market exclusivity, if TQS-168 is approved.