Genexine Co. Ltd.’s recombinant human growth hormone eftansomatropin alfa (GX-H9/TJ-101) met the primary endpoint in a phase III pediatric study conducted in China in children with growth hormone deficiency, and the company plans to file a BLA in 2024 in China on the data.
Blood biomarkers have been found in patients hospitalized with acute COVID-19 that are predictive of the cognitive defects of long COVID. Post COVID-19 deficits in cognition, including brain fog, are common and debilitating. They are also clinically complex, with both objective and subjective components. In the U.K., one in eight patients received their first ever neurological or psychiatric diagnosis within six months following COVID-19.
Phathom Pharmaceuticals Inc. made recent headway with its new mechanism of action in gastroesophageal reflux disease (GERD) even as further, disturbing discoveries in the space are seeing daylight. Florham Park, N.J.-based Phathom turned over to the U.S. FDA the requested six-month stability data related to reformulated vonoprazan tablets, and the numbers remained consistent with three-month data, reflecting N-nitroso-vonoprazan nitrosamine control and levels comfortably more than tenfold below the acceptable daily intake limit.
Neuraxis Inc. has initiated a clinical study to evaluate the efficacy of its IB-Stim neuromodulation system in treating children with post-concussion syndrome (PCS). The aim is to see whether IB-Stim can ease the constellation of symptoms that occur after mild traumatic brain injury such as headaches, dizziness and problems with concentration and memory.
The paper published June 19 in Nature Genetics that described a genome-wide analysis to narrow down the implicated pathogenic signaling pathways and “prioritize drug targets for IgA nephropathy [IgAN]” no doubt proved of great interest to developers, plenty of which are busy in the space.
Omnix Medical Ltd. is gearing up for a phase II trial next year of its novel peptide-based antibiotic OMN-6, the lead compound in a pipeline inspired by the antimicrobial strategies of insects.
The first seven months of 2023 saw clinical trial data up 1.43% compared to the same time period last year. From January through July this year, BioWorld reported on 2,064 drugs in phase I-III, compared to 2,035 in the same time period in 2022. The number of trial updates is down 14.07% from the 2,402 in 2021 and down from 2020’s 2,096, but up 18.15% from 2019’s 1,747.
A nonsteroidal eye drop formulation of dazdotuftide, TRS-01 missed its late-stage primary endpoint for controlling inflammation in uveitis, but developer Tarsier Pharma Ltd. said post-hoc analysis showing a boosted benefit-risk profile over steroids may be a ray of hope.
Heterozygous familial hypercholesterolemia (HeFH) patients treated with lerodalcibep achieved a 58.6% reduction in LDL-cholesterol at week 24 and a 65% reduction at the mean of weeks 22 and 24 in the phase III trial Liberate-HeFH. The developer, Cincinnati-based Lib Therapeutics Inc., was founded in 2015 when it licensed the technology from Bristol Myers Squibb Co. but is just now emerging from stealth.
Omnix Medical Ltd. is gearing up for a phase II trial next year of its novel peptide-based antibiotic OMN-6, the lead compound in a pipeline inspired by the antimicrobial strategies of insects.
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