Sanofi SA ((SNY)), Sanofi ((SNYNF)), Sanofi ((DE:SNW)) announced an update on their ongoing clinical study.
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Sanofi SA is conducting a Phase 1/Phase 2 open-label 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 (PKU). The study aims to reduce phenylalanine levels and eliminate the need for a Phe-restricted diet, which is significant for improving the quality of life for individuals with PKU.
The intervention being tested is SAR444836, administered as a single intravenous dose. It is designed to deliver a gene transfer therapy that could potentially offer a long-term solution for managing PKU by addressing the underlying genetic cause.
The study follows an interventional, single-group design with no masking, focusing on treatment. It includes a dose-escalation phase followed by a dose-expansion phase to determine the optimal dose for efficacy and safety.
The study began on August 7, 2023, with an estimated completion date of June 30, 2025. These dates are crucial for tracking the study’s progress and anticipating when results might impact the market.
This clinical update could positively influence Sanofi’s stock performance by showcasing their commitment to innovative treatments. The study’s progress may boost investor confidence, especially if early results are promising. Competitors in the gene therapy space will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.