NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) recently announced its strategic priorities for 2024, positioning itself for significant milestones in its clinical development programs. The company, a clinical-stage biopharmaceutical firm, is focused on developing oral, non-statin medicines for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol (LDL-C), for whom existing therapies are not sufficiently effective or well-tolerated.
The company's stock experienced a -2.2% movement, trading at $11.8 per share following the announcement.
Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam, expressed optimism about the upcoming phase 3 trial readouts and the potential impact on patients and shareholders. He stated, "NewAmsterdam is entering 2024 on the precipice of a major transformation, with the potential to deliver significant benefit to patients globally and create value for our shareholders."
Discussing the company's clinical development programs, Dr. Davidson highlighted, "In the year ahead, we are on track to report topline results from our first two pivotal phase 3 trials of obicetrapib, brooklyn and broadway. We are optimistic that these data will build on our prior phase 2 trials, where we observed a robust impact on lipid and lipoprotein parameters believed to be predictive of cardiovascular disease risk."
He further emphasized, "We continue to believe that our oral small molecule, low-dose, once-daily CETP inhibitor, if approved, has the potential to become the preferred LDL-C lowering therapy for the millions of dyslipidemia patients who are underserved by existing therapies."
NewAmsterdam provided an update on its ongoing phase 3 trials, including Brooklyn, Broadway, and Prevail, along with plans to initiate a fourth pivotal phase 3 trial, Tandem, in the first quarter of 2024. The company expects to complete enrollment in the Prevail cardiovascular outcomes trial in the first quarter of 2024 and report topline data in 2026.
Financially, the company believes its existing cash will be sufficient to fund operations through 2026, beyond the anticipated readout of its three ongoing phase 3 trials: Broadway, Brooklyn, and Prevail.
NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily cholesteryl ester transfer protein (CETP) inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk cardiovascular disease patients. The company's phase 2 trials have shown positive, statistically significant and clinically meaningful data, with a strong tolerability profile observed in more than 800 patients.
The full 8-K submission is available here.
