Following the readout of a phase II trial evaluating its COVID-19 oral antiviral Pentarlandir (SNB-01), Taiwan’s Syneurx International Corp. said it expects to launch a phase III test of the candidate in the next few months.
Data on C2N Diagnostic LLC’s new blood test combining a proprietary p-tau217 measurement with the amyloid beta (a-beta) 42/40 ratio, a component of C2N’s commercially available PrecivityAD blood test, could help to predict people at risk for Alzheimer’s disease (AD) – even at the earliest stages.
Epigenetic test company Volitionrx Ltd. appointed contract research organization (CRO) Diagnostic Oncology CRO LLC (DXOCRO) to conduct development and clinical validation studies for its Nu.Q product portfolio in the U.S. DXOCRO will carry out large-scale finding studies across the U.S. using Henderson, Nev.-based Volition's cancer tests to determine clinical utility in sepsis and cancer. The trials are aimed at U.S. FDA approval of the products.
Doctors will “unequivocally view as a major advance” Cincor Pharma Inc.’s oral baxdrostat for patients with treatment-resistant hypertension, said Deepak Bhatt, director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor at Harvard Medical School. “There are a lot of these folks out there, and physicians don’t know what to do with them right now,” he said, noting that many end up in emergency rooms.
Shares in Karuna Therapeutics Inc. soared Aug. 8 as the biotech moved closer to a breakthrough for schizophrenia therapy after its potential first-in-class drug Karxt (xanomeline + trospium) met its goals in a closely watched phase III trial. Analysts said results from the Emergent-2 trial were at the top end of what was expected, lifting Karuna’s shares (NASDAQ:KRTX) 71.8% to a 52-week high of $241.19.
Bellaseno GmbH began recruiting patients in Australia for two clinical trials of its resorbable breast scaffold products on Aug. 4. The company expects to enroll 10 patients with pectus excavatum, a structural deformity of the chest in which the breastbone presses inwards.
With data due later this summer from the phase II Pioneer trial testing Blueprint Medicines Corp.’s approved Ayvakit (avapritinib), many investor eyes are on the potential label expansion into indolent systemic mastocytosis – but the company has another potential ace in the hole with BLU-451, which targets EGFR exon 20 insertion mutations in non-small-cell lung cancer (NSCLC).
Akili Interactive Labs Inc. has kicked off a phase III study of its digital treatment for children with attention-deficit/hyperactivity disorder (ADHD) living in Japan, the first pivotal trial of its video game-based cognitive treatment outside the U.S. Conducted by Osaka-based Shionogi & Co. Ltd., this marks the first pivotal trial of Akili’s video game-based cognitive treatment outside the U.S.
Beta-site APP-cleaving enzyme 1 (BACE1) inhibitors have a long history of failure in patients with Alzheimer’s disease. Clinical development of verubecestat, elenbecestat, lanabecestat, umibecestat, atabecestat and LY-3202626 were all discontinued. The drugs largely showed that inhibiting BACE1 reduced amyloid beta (AB) in both cerebrospinal fluid and plasma, reduced AB plaques on PET scans and reduced phosphorylated tau. Unfortunately, patients had early cognitive worsening, and there were signs of lowering of brain volume and increases in psychiatric adverse events.
During a presentation at the Alzheimer's Association International Conference 2022, researchers from the Genetic Frontotemporal Dementia (FTD) Initiative consortium presented data from a study following nearly 1,300 patients with FTD caused by a genetic mutation, their presymptomatic family members who have the inherited mutation and unaffected family members to serve as controls. Researchers have used data from the study, which has been enrolling patients for over 10 years, to develop biomarkers that can be used to assess progression of FTD in interventional clinical trials.
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