Here’s what you should know.
1. An independent data monitoring committee analyzed data from the first 65 patients, who completed the 12 week trial.
2. The committee deemed the trial was too futile to continue after it analyzed data related to clinical remission. No safety concerns were noted in the analysis, however.
3. Protagonist notified investigators further treatment should be discontinued. The company is also tabling a planned phase 2/3 clinical trial of PTG-100 in chronic pouchitis patients until the data from this trial can be fully reviewed.
4. Protagonist CEO and President Dinesh Vatel, PhD, said, “We are very disappointed with this futility-based outcome which was also accompanied by an unexpectedly high placebo rate. We will conduct an extensive review of the complete dataset on the totality of patients enrolled in the trial before making any further decisions about the future development of PTG-100.”
5. The company’s shares fell 61 percent on the news, from $20.43 per share March 26 to $7.86 per share March 27.
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