Junshi Biosciences Co. Ltd.’s ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, met the primary endpoints of reducing the levels of low-density lipoprotein cholesterol in two phase III trials in primary hypercholesterolemia and mixed hyperlipidemia.
Tricuspid valve regurgitation has lagged mitral regurgitation where device development is concerned, but new one-year data from the TRILUMINATE study of the Triclip device suggests that device therapy is safe and cuts down on regurgitation in a manner that makes the condition much more tolerable for patients. At this point, however, the data do not yet offer much difference when it comes to mortality and rehospitalization compared to medical management, a gap Abbott will have to overcome if it wants to maximize its investment in this underdeveloped area of medical technology.
Abbott Laboratories scored a major win for its Mitraclip device thanks to data from the COAPT study for secondary mitral valve regurgitation. The latest data from this study show a stunning difference in two-year mortality compared to maximized medical management only – 29% on the device versus 46% on medical management – but differences between the COAPT study results and outcomes seen in the MITRA-FR study will force cardiologists to dive into the data to ensure that their patient selection practices account for critical differences in the conduct of these two studies.
Findings published in Nature showing that dual blockage of PD-L1 and CD47 can boost the therapeutic effects of oxaliplatin chemotherapy as well as the FOLFOX regimen – in a CT-26 mice tumor model, anyway – served to highlight CD47, a target that has spurred added efforts of late.
The U.S. Recover program, set up in July 2022 to identify the causes of long COVID, find biomarkers of disease and discover new therapeutic targets, is now preparing to move to its next phase and begin testing potential treatments in a multi-arm, randomized, placebo-controlled trial. But with 200 different symptoms, and limited understanding of relevant system-level pathological targets, there are significant hurdles to be overcome.
Positive results from Bridgebio Pharma Inc.’s phase II study of infigratinib in children with achondroplasia, a genetic disease that inhibits bone length and leads to short stature, prompted the company stock to surge. Participants receiving the highest dosage, which was the fifth cohort getting 0.25 mg/kg daily, saw a 3.03-centimeter increase, about 1.19 inch, in their height annually, which produced a “p” value of 0.0022.
Esperion Therapeutics Inc.’s full results from the phase III outcomes trial called Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen, known by the rough acronym CLEAR, inspired excitement in the mainstream media worldwide but not on Wall Street, as numbers from the experiment fell short of what some wanted. Though the findings proved unmistakably positive, shares of Ann Arbor, Mich.-based Esperion (NASDAQ:ESPR) dropped almost 20% or $1.27 to close March 6 at $5.08.
Praxis Precision Medicines Inc. CEO Marcio Souza said it would be “disingenuous not to move forward” – U.S. FDA willing – into a phase III effort with an alternate design targeted for the second half of this year, given top-line results from the phase IIb Essential-1 study with ulixacaltamide (PRAX-944) for essential tremor.
Inovio Pharmaceuticals Inc. has “more work to do” in understanding mixed results with the DNA-based immunotherapy VGX-3100 as a treatment for cervical high-grade squamous intraepithelial lesions associated with human papillomavirus (HPV)-16 or HPV-18, said Michael Sumner, chief medical officer for the company. “We only got the data in our hands about a week ago.”
Junshi Biosciences Co. Ltd.’s ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, met the primary endpoints of reducing the levels of low-density lipoprotein cholesterol in two phase III trials in primary hypercholesterolemia and mixed hyperlipidemia.
RSS
