NewAmsterdam Pharma (NASDAQ: NAMS) has announced positive topline data from its pivotal phase 3 TANDEM clinical trial evaluating the fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk factors and/or heterozygous familial hypercholesterolemia (HeFH). The trial achieved all co-primary endpoints of least squares mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies versus each of placebo, ezetimibe 10 mg, and obicetrapib 10 mg monotherapy at day 84 with statistical significance (p<0.001).
The data showed that the obicetrapib and ezetimibe fixed-dose combination observed to lower LDL-C by approximately 50% at day 84, compared to placebo, with over 70% of patients achieving LDL-C levels below 55 mg/dl. The safety results were in line with prior studies, and the fixed-dose combination was observed to be well tolerated.
The trial met all co-primary endpoints, including the fixed-dose combination achieving an LS mean reduction of 48.6% (p < 0.0001) compared to placebo at day 84. The observed reductions in all co-primary endpoints are summarized below:
- LDL-C percentage change:
- Ezetimibe (n=101): mean -23.3%, median -22.6%
- Obicetrapib (n=102): mean -35.5%, median -37.2%
- Obicetrapib and ezetimibe FDC (n=102): mean -52.2%, median -54.0%
The study drug-related treatment emergent adverse events (TEAEs) and study drug-related treatment emergent serious adverse events (TESAEs) were low and comparable across the treatment arms.
The company's Chief Scientific Officer, John Kastelein, M.D., Ph.D., FESC, highlighted the clinically meaningful and statistically significant LDL-C lowering, stating that the data supports a potential new treatment option for physicians and improved patient care for those impacted by CVD.
NewAmsterdam's CEO, Michael Davidson, M.D., emphasized the promising results to support regulatory filings globally and the potential for the fixed-dose combination to significantly reduce LDL-C and improve cardiovascular outcomes.
The pivotal phase 3 TANDEM trial was a randomized, double-blind, four-arm, placebo-controlled multicenter study involving 407 patients with HeFH and/or ASCVD or ASCVD risk equivalents. The trial evaluated the effect of 10 mg obicetrapib and 10 mg ezetimibe as a fixed-dose combination on LDL-C levels, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo.
NewAmsterdam plans to present additional results from TANDEM at an upcoming medical conference and to publish the data in a major medical journal.
The company's global pivotal phase 3 program consists of four studies in over 12,250 patients, including trials for obicetrapib monotherapy and a fixed-dose combination of obicetrapib and ezetimibe. The company is also conducting additional trials to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events.
NewAmsterdam is focused on addressing the unmet need for a safe, well-tolerated, and convenient LDL-lowering therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. As a result of these announcements, the company's shares have moved -14.7% on the market, and are now trading at a price of $20.2. If you want to know more, read the company's complete 8-K report here.
