Results from NewAmsterdam Pharma’s Phase 3 BROADWAY and TANDEM trials suggest that obicetrapib could be an effective LDL-C lowering treatment, both on its own or combined with another drug.
TANDEM examined the effects of a fixed-dose obicetrapib/ezetimibe combination therapy and found…
- An LDL-C reduction of ~50% at day 84 of treatment compared to placebo.
- Over 70% of patients achieved LDL-C levels below 55mg/dL.
- Adverse events were similar to placebo.
BROADWAY put on a one-man show for obicetrapib as a monotherapy to help confirm its solo effectiveness, finding that the CETP inhibitor led to…
- An LDL-C reduction of 33% at day 84 compared to placebo.
- A 21% MACE risk reduction at one year follow-up.
Pooled data from the BROADWAY, TANDEM, and BROOKLYN trials also showed…
- A 45% median Lp(a) reduction in patients with Lp(a) baseline levels of 50-150 nmol/L.
The Takeaway
NewAmsterdam’s obicetrapib seems to be on track to provide high LDL-C patients with an effective alternative to statins following these Phase 3 results. That could be a big win for patients who suffer from genetic causes of high LDL-C if NewAmsterdam’s coming regulatory submissions succeed.
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