Ironwood Pharmaceuticals (NASDAQ:IRWD) has reached alignment with the FDA on certain updates to its Phase III clinical program evaluating IW-3718 in adults with refractory gastroesophageal reflux disease (GERD).
The primary endpoint for the two identical trials: IW-3718-301 and IW-3718-302 has been changed from the previous responder endpoint to a continuous endpoint.
The primary endpoint is now the assessment of change from baseline to week 8 in weekly heartburn severity scores as compared to the original primary endpoint of an overall heartburn responder.
The original primary endpoint has been moved to become one of the key secondary endpoints, along with a change in weekly regurgitation frequency and the proportion of heartburn-free days.
Ironwood plans to stop enrollment in IW-3718-302 to conduct an early assessment of efficacy. The outcome of this assessment is expected to be reported in Q4.
The company is also in discussions with the FDA regarding its request for long-term safety data for IW-3718 in connection with a NDA submission.
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