Vasc-Alert LLC’s surveillance technology successfully predicts which dialysis patients are at risk of experiencing stenosis, a study published in the Journal of Vascular Access shows. Patients assigned high scores by the company’s algorithm had seven times the risk of stenosis and blockage compared to those with low-risk scores.
A lack of available options for treating idiopathic pulmonary fibrosis (IPF) is driving plenty of development into the indication. The latest data come from Pliant Therapeutics Inc., which posted positive 12-week interim data from 21 participants in the 320-mg dose group’s active arm and eight in the placebo arm in its phase IIa study of PLN-74809 (bexotegrast).
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating adeno-associated virus (AAV) gene replacement therapy AT-845 in adults with late-onset Pompe disease.
Upcoming catalysts from Annexon Biosciences Inc. put some joy into shares as the firm talked up its prospects during the recent J.P. Morgan Healthcare Conference, where attendees heard Jan. 8 about the news ahead with C1q protein complex inhibitor ANX-005 in Huntington’s disease (HD) as well as progress in Guillain-Barre syndrome (GBS), and more. The stock (NASDAQ:ANNX) enjoyed a 43% stock boost in the days after JPM, rising from $4.79 on Jan 8 to $6.84 on Jan. 13.
A year and a half gone, two HIV vaccine studies shut down. That’s the case with the Janssen Pharmaceutical Cos. of Johnson and Johnson as the phase III Mosaico study of its HIV vaccine regimen was not effective in preventing infection compared to placebo. Based on a data and safety monitoring board’s report saying the study was not expected to hit its primary endpoint, Janssen discontinued the clinical trial more than a year ahead of its estimated March 2024 completion date.
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults.
Irlab Therapeutics AB’s phase IIb exploration of the dopamine D3-receptor with the Ipsen SA-partnered oral antagonist mesdopetam in Parkinson’s disease (PD) levodopa-induced dyskinesia (LID) fell short in terms of the primary endpoint, but the company is holding out hope. Mesdopetam missed the primary endpoint of change in daily hours of “on” time – periods of adequate PD control – without troublesome dyskinesia as shown in patient diaries, the company said.
In what is claimed as the largest study of how digital technologies were applied to support population level research during the pandemic, scientists at the U.K. Medical Research Council’s epidemiology unit at Cambridge University have reported high, sustained levels of engagement in a fully remote COVID-19 study that ran at a time when visits to a study center were not possible.
The accelerated approval by the U.S. FDA of Immunogen Inc.’s landmark antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx) injected further oomph into the NaPi2b space, where a handful of developers are due to yield important data shortly. In play are such names as Mersana Therapeutics Inc. and Zymeworks Inc., encouraged by historical – if not entirely successful – efforts by giant Roche Holding AG.
A study in a mouse model of tau protein build-up in the brain, similar to that seen in later stage Alzheimer’s disease (AD), shows that changes to the microbiome in these animals can impact the degree and progression of neurodegeneration observed. As reported in the Jan. 12, 2023, study published in Science, the researchers found that mice that were germ free and those given antibiotics to change their gut microbiome early in life had significant reductions in brain atrophy compared with those with a standard microbiome.
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