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Cogent Biosciences Reaches Alignment With US FDA to Use Patient-Reported Symptom Tracking in Trial
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Cogent Biosciences Reaches Alignment With US FDA to Use Patient-Reported Symptom Tracking in Trial
Jun 27, 2024 7:07 AM

09:44 AM EDT, 06/27/2024 (MT Newswires) -- Cogent Biosciences ( COGT ) said Thursday that it has reached alignment with the US Food and Drug Administration for the use of patient-reported symptom tracking in the second part of a study to test bezuclastinib in nonadvanced systemic mastocytosis patients.

The Mastocytosis Symptom Severity Daily Diary is a questionnaire that asks participants about their symptoms and tracks any changes in symptom severity over the course of the trial, the company said.

The total symptom score derived from the eleven most common and severe reported symptoms will be used to assess the primary endpoint of the trial, Cogent added.

Enrollment for the trial, dubbed Summit part 2, is planned to be completed by Q2 next year, with top-line results expected by the end of next year, Cogent said.

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