Merck announced that it is targeting to develop therapies for four key cardiovascular indications, pulmonary arterial hypertension (PAH), atherosclerosis, thrombosis, and heart failure.
Pulmonary Arterial Hypertension
Sotatercept - A Phase 3 trial was completed
MK-5475 - Phase 2/3 tria
MK-0616 - Completed Phase 2 dose finding study
Merck has presented the positive results from a Phase 2b study of MK-0616, a PCSK9 inhibitor. MK-0616 significantly reduced low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, in patients with hypercholesterolemia. PCSK9 inhibition results in the reduction of LDL-C in the blood.
A daily dose of four strengths was evaluated (6, 12, 18, and 30 mg). The percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to week 8 was the key metric to determine the efficacy. All four doses have demonstrated efficacy: 6 mg, 41.2%, 12 mg, 55.7%, 18 mg, 59.1%, and 30 mg, 60.9%.
Further, there was a reduction in ApoB levels (32.8% to 51.8%) and non-HDL-C levels (35.9% to 55.8%).
The drug was also well-tolerated, with no significant safety concerns identified.
Merck plans to continue testing MK-0616 in Phase 3 clinical trials and is expected to initiate in the second half of 2023.
Merck has announced positive results from the Phase 3 STELLAR trial of its investigational drug sotatercept for treating pulmonary arterial hypertension (PAH). Sotatercept is an activin signaling inhibitor, which is being evaluated for PAH (WHO type 1) patients.
The study found that sotatercept significantly improved the distance patients could walk in six minutes by an average of 40.8 meters compared to placebo after 24 weeks of treatment. It also demonstrated improvement in eight out of nine secondary measures.
PAH is a progressive and debilitating disease characterized by high blood pressure in the lungs' arteries, which can lead to heart failure and death.
Janssen announced the Phase 3 data of a single-tablet combination of macitentan and tadalafil, demonstrating significant improvement in pulmonary hemodynamics in patients with pulmonary arterial hypertension (PAH).
The single-tablet combination has demonstrated statistically significant improvement versus macitentan and tadalafil monotherapies in patients with functional class II or III PAH. The primary endpoint was the change in Pulmonary Vascular Resistance (PVR).
The PVR change with the combination pill was significant versus macitentan (treatment effect: 29%) and tadalafil (treatment effect: 28%) monotherapies.
The trial also demonstrated significant improvements in exercise capacity, as measured by the 6-minute walk distance test. The combination therapy was generally well-tolerated, with no new safety concerns identified.
Amgen announced that it would present new data on its products Repatha (evolocumab) and olpasiran at the American College of Cardiology (ACC) meeting.
For Repatha, the company will present the results of Phase 3 FOURIER and FOURIER-OLE studies. The FOURIER study has a median follow-up of 2.2 years, and FOURIER-OLE has a median follow-up of three years. In both trials, all the primary endpoints were monitored.
Amgen announced that it would also present the results of Phase 2 OCEAN(a)-DOSE study of olpasiran. The siRNA-based therapy has reduced lipoprotein(a) [Lp(a)] by more than 90%.
A study conducted in real-world settings has revealed that Xarelto has a lower risk of adverse kidney outcomes compared to vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD).
XARENO is the real-world evidence aimed to determine the effectiveness and safety of a NOAC versus VKAs for treating NVAF and advanced CKD. It is critical to avoid worsening renal function and prevent stroke while selecting the orals for treating NVAF patients.
The study revealed that after a median follow-up of 2.1 years, adverse kidney outcomes occurred 8.3 patient years versus 12.7 times in the VKA group. The study found that patients treated with Xarelto had a 30% lower risk of experiencing adverse kidney outcomes than those who received VKAs.