NewAmsterdam Pharma announced positive topline data from its Phase 3 TANDEM clinical trial, evaluating the fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg. The trial met all co-primary endpoints, demonstrating a statistically significant reduction in LDL-C compared to placebo, ezetimibe monotherapy, and obicetrapib monotherapy.
The obicetrapib and ezetimibe fixed-dose combination achieved an LS mean reduction of 48.6% (p < 0.0001) in LDL-C compared to placebo at day 84. This efficacy resulted in over 70% of patients achieving LDL-C levels below 55 mg/dL, a critical target for high-risk cardiovascular patients.
The fixed-dose combination was observed to be well-tolerated, with safety results comparable to placebo and consistent with previous clinical studies. These results are expected to support global regulatory filings for the fixed-dose combination, offering a new oral treatment option for patients with inadequately controlled LDL-C.
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