Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Sanofi is conducting a Phase 1/Phase 2 open-label study titled A Phase 1/Phase 2, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of SAR444836, an Adeno-associated Viral Vector-mediated Gene Transfer of Human Phenylalanine Hydroxylase, in Adult Participants With Phenylketonuria. The study aims to assess the safety and efficacy of SAR444836 in reducing phenylalanine levels in adults with phenylketonuria (PKU), potentially eliminating the need for a Phe-restricted diet.
The intervention being tested is SAR444836, an adeno-associated virus vector-mediated gene transfer of human phenylalanine hydroxylase, administered as a single intravenous infusion. Its purpose is to treat PKU by reducing phenylalanine levels in the blood.
This interventional study follows a single-group, open-label design with no masking. It consists of two parts: dose escalation and dose expansion, focusing on treatment as the primary purpose.
The study began on August 7, 2023, and is currently recruiting participants. The primary completion and estimated completion dates are not specified, but the last update is scheduled for July 28, 2025. These dates are crucial for tracking the study’s progress and potential market entry.
The outcome of this study could significantly impact Sanofi’s stock performance by potentially introducing a novel treatment for PKU. Positive results may enhance investor sentiment and position Sanofi favorably against competitors in the gene therapy market.
The study is ongoing, with further details available on the ClinicalTrials portal.