Denali Therapeutics ((DNLI)) announced an update on their ongoing clinical study.
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Denali Therapeutics has launched an open-label extension study titled An Open-Label Extension to Investigate the Long-Term Safety, Tolerability, and Efficacy of DNL310 in Patients With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007. The study aims to evaluate the long-term safety, tolerability, and efficacy of tividenofusp alfa, an investigational CNS-penetrant enzyme replacement therapy for Hunter syndrome, a rare genetic disorder.
The intervention being tested is tividenofusp alfa, a drug administered intravenously. It is designed to penetrate the central nervous system and provide enzyme replacement therapy for patients with MPS II.
The study follows a non-randomized, parallel intervention model with no masking, focusing on treatment. It includes multiple cohorts of participants with varying ages and conditions related to MPS II.
The study began on September 18, 2023, and the last update was submitted on September 24, 2025. These dates are crucial as they mark the study’s initiation and the latest progress update, indicating the study’s ongoing nature.
This update could influence Denali Therapeutics’ stock performance positively, as successful long-term results may boost investor confidence and position the company favorably against competitors in the CNS and rare disease treatment markets.
The study is currently ongoing, with further details available on the ClinicalTrials portal.