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January 10, 2022updated 11 Jul 2022 2:13pm

NewAmsterdam Pharma initiates Phase III trial for obicetrapib

By GlobalData Healthcare

NewAmsterdam Pharma has announced dose administration for the first patient in its Phase III BROADWAY trial for its lead candidate, obicetrapib, in adults with heterozygous familial hypercholesterolemia (HeFH) and/or established atherosclerotic cardiovascular disease (ASCVD). Obicetrapib is an orally administered novel cholesteryl ester transfer protein (CETP) inhibitor.

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BROADWAY is a placebo-controlled, double-blind, randomized 52-week study that will investigate obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy among adults with HeFH and/or ASCVD who require additional lowering of low‑density lipoprotein cholesterol (LDL-C), which is often referred to as ‘bad’ cholesterol as high levels increase the risk of major adverse cardiovascular events (MACE). The company plans to randomise 2,400 patients to treatment with either placebo or 10mg obicetrapib once daily. The primary objective of the trial is to evaluate the effects of treatment on LDL-C levels, with the results of the study expected in Q1 2024.  

However, obicetrapib’s path to Phase III development has faced difficulties, and many within the cardiovascular disease (CVD) sector will be surprised that it has reached this stage at all. Originally developed by Dezima Pharma, obicetrapib was one of several developmental CETP inhibitors that garnered interest in the 2000s and early 2010s. These drugs were proclaimed as having the potential to raise levels of high-density lipoprotein cholesterol (HDL-C), which is often referred to as ‘good’ cholesterol. However, following a number of high-profile Phase III trial failures due to lack of efficacy (such as with Roche’s dalcetrapib and Eli Lilly’s evacetrapib), enthusiasm for the drug class began to wane. Amgen gained the rights to obicetrapib in 2015 following its acquisition of Dezima Pharma, but in 2017 the company discontinued development of the drug. Later, some of the former founders of Dezima Pharma founded NewAmsterdam Pharma with the intention of regaining the rights to obicetrapib. NewAmsterdam Pharma in-licensed the drug from Amgen in August 2020 and subsequently raised $195m in series A financing to advance its development. Investors were rewarded for their efforts in July 2021 when topline results from the Phase II ROSE trial, which investigated obicetrapib as an adjunct to high-intensity statin therapy, demonstrated unprecedented effects of CETP inhibition on HDL-C increase and LDL-C reduction.

Obicetrapib is once again generating interest in the CVD space with its potential to significantly reduce LDL-C in patients who are unable to achieve LDL-C targets despite treatment with maximally tolerated statins. NewAmsterdam Pharma has also indicated that obicetrapib may have repositioning potential in other diseases, such as diabetes and Alzheimer’s disease, in which CETP inhibition has been genetically validated.

Although the CETP inhibitor drug class was previously dismissed as futile in general, it could yet prove to be effective in CVD and beyond. According to GlobalData’s Pipeline Products database, there are five other CEPT inhibitors currently in active development globally. One of these, dalcetrapib, is in late-stage clinical development. Although Roche discontinued development of dalcetrapib in 2012 due to a lack of efficacy, the company out-licensed the drug to DalCor Pharmaceuticals in 2015. Based on a retrospective analysis of Roche’s original data, DalCor Pharmaceuticals determined that the drug had potential as a precision medicine in a subset of patients with the ADCY9 AA genotype and initiated a Phase III trial in this patient population. The drug is also being repositioned as a potential anti-viral treatment for Covid-19. A Phase II, proof-of-concept trial was instigated in January 2021 based on the rationale that dalcetrapib binds to the catalytic site of 3CLMpro, the main protease of the SARS-CoV-2 virus, in vitro.

The remaining four CEPT inhibitor pipeline therapies are all indicated for CVD or dyslipidemia. They include a drug candidate in Phase I development in the EU by Chong Kun Dang Pharmaceutical Corp, as well as drug candidates in development by Bristol-Myers Squibb, Shenyang Pharmaceutical University and China Pharmaceutical University, all of which are in preclinical development globally.

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