NewAmsterdam Pharma has reported positive data from the Phase II ROSE clinical trial of its experimental drug, obicetrapib, to treat dyslipidemia.
A selective inhibitor of cholesteryl ester transfer protein, obicetrapib is being developed to reduce low-density lipoprotein cholesterol (LDL-c) and avert crucial adverse cardiovascular events.
The double-blind, placebo-controlled, randomised trial analysed the safety, efficacy and tolerability of obicetrapib in 120 subjects.
These participants were categorised to receive either 5mg or 10mg dose of obicetrapib or placebo for eight weeks.
In the trial, obicetrapib was analysed as a single agent and along with ezetimibe, as an adjunct to high-intensity statin therapy.
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By GlobalDataFindings showed that treatment with 5mg and 10mg obicetrapib offered a 42% and 51% decline in LDL-c, respectively, versus baseline compared with a 7% decline in the placebo arm.
Nearly 47.5% of the subjects in the placebo arm reported adverse events (AEs) as against 32.5% and 20% in the 5mg and 10mg obicetrapib arms, respectively.
Furthermore, two serious AEs were noted in the placebo group while no serious AEs were observed in the two tretament arms.
Obicetrapib was found to be safe and well-tolerated in trial subjects receiving the treatment.
Subjects treated with 5mg or 10mg doses of the drug reported a 45% and 48% rise in apolipoprotein A-I HDL levels, respectively.
In July, the company had reported that the trial met its primary goal at both the tested doses of the drug.
NewAmsterdam Pharma chief scientific officer John Kastelein said: “These clinical data are tremendously exciting in that they confirm the genetic validation of CETP inhibition as an LDL-lowering mechanism and show the effect of obicetrapib is just as robust in patients on high-intensity statins as it is in patients who are statin-intolerant, which has been a core pillar of our company strategy for developing obicetrapib in cardiovascular diseases and other major diseases of high unmet need.”
The company plans to commence Phase III trials of the drug in the fourth quarter of this year.
