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.
Although strides have been made in the space, biopharma’s hunt for a wider net to cast in vaccines for pneumococcal disease has recruited the likes of Vaxcyte Inc., GSK plc and Merck & Co. Inc., each racing for a candidate with improved valence.
Oramed Pharmaceuticals Inc. has had a lot of success with testing its oral insulin, until now. The company will discontinue it oral insulin clinical work in treating type 2 diabetes after ORMD-0801 failed to hit its phase III study’s primary and secondary endpoints. The late-stage stumble clobbered the company stock (NASDAQ:ORMP), which lost 76% of its value on Dec. 12 to close at $2.54 each.
Alpine Immune Science Inc.’s update in its earnings report Nov. 14 on its ALPN-303 program added more intrigue to the notion of targeting B cell cytokines B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) together in lupus, as other players are trying the dual approach as well, including China’s Remegen Co. Ltd. and Vera Therapeutics Inc.<
Clinical trials in China are growing up in much the same way the R&D enterprise in China has grown up. They are evolving and becoming more sophisticated, reflecting the maturation of the R&D environment around them.
The serious adverse event in the first phase I/II patient dosed with nulabeglogene autogedtemcel (nula-cel) – a gene editing, autologous hematopoietic stem cell therapy for sickle cell disease (SCD) – may have involved the quality of the stem cells and not the conditioning regimen or characteristics of the patient at baseline. But researchers won’t know until more work is done.
Biontech SE is piggybacking on the U.K.’s lead in implementing cancer genomics in routine health care to set up a national clinical trial of personalized mRNA cancer vaccines that are based on the mutational landscape of individual tumors.
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