Shots:
Bluejay Therapeutics has enrolled its first patient in the P-III (AZURE-2) trial assessing brelovitug (300mg, SC, QW) vs Hepcludex (bulevirtide) for the treatment of chronic hepatitis D
Trial will assess the proportion of participants achieving a composite response at Wk. 48, defined as undetectable hepatitis D virus RNA along with normalization of alanine aminotransferase…
Shots:
Ionis has reported P-III (CORE: n=617 & CORE2: n=446) trials data assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in adults with severe hypertriglyceridemia (sHTG); the US FDA’s sNDA submission expected by year end
Both studies met their 1EP, with CORE showing reduction in fasting triglycerides by 72% (80mg) & 63%…
Shots:
Merck has reported topline P-III (CORALreef Lipids) trial data assessing enlicitide decanoate vs PBO for the treatment of adults with hypercholesterolemia receiving mod. to high-intensity statins or are intolerant to statins
Trial met its 1EP with significant LDL-C reduction at Wk. 24 & achieved 2EPs, showing reduced non-HDL-C, apolipoprotein B, & lipoprotein(a) levels; data…
Shots:
Novartis has reported P-IV (V-DIFFERENCE) trial results evaluating Leqvio (n=898) vs PBO (n=872), both added to personalized lipid-lowering therapy (LLT), in 1,770 hypercholesterolemia pts not at guideline-recommended LDL-C goals
Trial showed 85% vs 31% achieved their guideline-recommended LDL-C target after 90 days of treatment, with benefits seen as early as day 30 (81% on…
Shots:
The STEER real-world study data assessed the risk of major adverse cardiovascular events (MACE) with Wegovy (semaglutide 2.4mg) vs tirzepatide among overweight or obese pts with CVD, but no diabetes in the US
Study showed that continuous treatment (>30 days no gap) with Wegovy reduced risk of heart attack, stroke, CV or all-cause death…
Shots:
The P-III (BaxHTN) trial assessed baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment resistant hypertension over 12wks.; P-III (Bax24) trial readout is expected in late 2025
Trial met its 1EP, reducing mean seated SBP at 12wks. by 15.7 (2mg) & 14.5 mmHg (1mg), with PBO-adjusted…
Shots:
Merck has reported P-III (VICTOR) trial data assessing Verquvo (n=3,053) vs PBO (n=3,052) in pts with stable chronic heart failure & reduced ejection fraction
Trial did not meet its 1EPs of reducing CV death or HF hospitalization (18% vs 19.1%); however, 2EPs showed numerically lower rates of CV death (9.6% vs 11.3%) & HF…
Shots:
Zydus has reported topline P-IIb/III (EPICS-III) trial results in PBC pts resistant or intolerant to ursodeoxycholic acid (UDCA), where pts were randomized to Saroglitazar (1mg) or PBO, following optimal dose selection
Trial met its composite 1EP, showing a 48.5% treatment difference in biochemical response, & also achieved its key 2EP with a higher proportion…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:
argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis
Read More: argenx
PDS Biotech Reports Final P-II (VERSATILE-002) Survival Data for PDS0101 + Keytruda…
Shots:
The P-I/II (BGB-11417-201) trial of sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on sonrotoclax (160 or 320mg, QD), while Part 2 enrolled 103 pts on 320mg QD after ramp-up
Trial met its 1EP of improved ORR per IRC & showed significant improvements across 2EPs,…

