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Initial Results From Ontarget Study Show That Multicenter, Double-Blind, Placebo-Controlled Pivotal Clinical Trial Did Not Meet Primary Endpoint
Jaguar Health (NASDAQ:JAGX) announced results from its Phase 3 OnTarget trial of crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy. The trial did not meet its primary endpoint across all tumor types. However, it revealed clinically relevant signals for crofelemer in prespecified subgroups of patients with breast and respiratory cancer, including lung cancer. These subgroups comprised over 75% of trial participants.
Key takeaways:
Trial included 10 tumor types and 24 targeted agents
Positive signals improved over the initial 12-week phase
Crofelemer was well-tolerated with an adverse event profile similar to placebo
Company plans to engage with FDA after full data review
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