Shenaz Bagha

The FDA has granted orphan drug designation to Cabaletta Bio’s CAR T-cell investigational therapy for the treatment of systemic sclerosis, according to a press release from the manufacturer. The drug, currently known as CABA-201, is a 4-1BB-containing, fully human CD19-CAR T cell, Cabaletta said in the release. According to the company, a clinical trial program including four phase 1/2

The first subject has been dosed in a phase 1 clinical trial of an oral proteolysis-targeting chimera protein degrader to treat neurodegenerative diseases, according to the manufacturer.According to a release from Arvinas, ARV-102 was shown to cross the blood-brain barrier and degrade leucine-rich repeat kinase 2 (LRRK2) in preclinical studies. This property was crucial to efficacy as increased

The FDA has cleared an investigational new drug application for an unmodified neural-derived exosome to treat those with acute ischemic stroke, according to its manufacturer.In a press release, Aruna Bio Inc. said the FDA’s decision will allow its lead program, AB126, which can cross the blood-brain barrier, to be examined in a pending phase 1b/2a study that is expected to begin during the

A biotechnology company announced the first patient was dosed in its phase 2a clinical trial of intranasal foralumab, a monoclonal antibody treatment for those with non-active secondary-progressive multiple sclerosis.According to a release from Tiziana Life Sciences Ltd., foralumab is an anti-CD3 monoclonal antibody that binds to the T-cell receptor and dampens inflammation by modulating T-cell

A clinical-stage biopharmaceutical company has announced positive findings from the exploratory SHAPE phase 2 clinical trial to evaluate fosgonimeton in those with Parkinson’s disease dementia and dementia with Lewy bodies.According to a release issued by Athira Pharma, the investigational, small molecule ATH-1017 is designed to positively modulate the hepatocyte growth factor (HGF) system,

A company specializing in treatment for neurodegenerative diseases announced positive topline data from a phase 2b clinical trial of a novel, extended release oral fixed-dose therapeutic to treat amyotrophic lateral sclerosis. According to a release from NeuroSense Therapeutics Ltd., the study met its primary safety and tolerability endpoints as well as secondary clinical efficacy endpoints in

MindMed has announced positive topline results from its phase 2b clinical trial of MM-120 in generalized anxiety disorder, according to a company press release.The trial met its primary endpoint, with MM-120 (lysergide D-tartrate) demonstrating a “statistically significant” dose-dependent improvement on the Hamilton Anxiety rating scale (HAM-A) compared with placebo at 4 weeks,

The first two female pediatric patients with Rett syndrome have been dosed in an ongoing phase 1/2 trial of investigational AAV9 gene therapy NGN-401, according to the manufacturer.According to a release from Neurogene Inc., NGN-401 was purposefully designed and administered to maximize therapeutic activity while averting transgene overexpression toxicities. The novel therapeutic delivers the

A phase 2 clinical trial has been initiated to evaluate the safety and efficacy of an inverse agonist for hallucinations and delusions associated with Alzheimer’s disease psychosis, according to the manufacturer. According to a release from Acadia Pharmaceuticals, that the global, multicenter, randomized, double-blind, placebo-controlled trial will be the first part of a program expected to

The FDA has cleared a traumatic brain injury blood test for commercial availability, paving the way for its distribution to hospitals in the United States. According to a release from Abbott, the test will run on the company’s Alinity i laboratory instrument, which aims to provide clinicians with a rapid, objective way to assess mild traumatic brain injury (TBI) or concussion in