Clinical-stage biopharmaceutical company Alto Neuroscience Inc (NYSE:ANRO) announced on Friday that the US Food and Drug Administration (FDA) has granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS).
CIAS is a core feature of schizophrenia with no currently approved treatments, significantly affecting daily functioning and quality of life.
ALTO-101 is a novel phosphodiesterase-4 (PDE4) inhibitor that has shown pro-cognitive effects in healthy volunteers. By inhibiting PDE4, ALTO-101 increases cAMP levels in the brain, potentially enhancing neuronal signalling and synaptic plasticity, which are critical to learning and memory.
Fast Track designation is intended to accelerate the development and review of therapies for serious conditions with unmet medical needs. This status may allow for more frequent FDA interactions and potential eligibility for accelerated approval and priority review.
ALTO-101 is currently being evaluated in an ongoing Phase 2 proof-of-concept study in patients with CIAS.
Precision NeuroMed's glioblastoma multiforme treatment granted FDA Orphan Drug Designation
Merck completes acquisition of Verona Pharma to expand cardio-pulmonary portfolio
Oxford Biomedica expands US operations with acquisition of viral vector facility in North Carolina
DarioHealth and OneStep partner to integrate fall risk technology into digital health platform
Ananda Pharma achieves key Phase 1 milestone for MRX1 CBD program
Alvotech and Advanz Pharma announce EMA acceptance of AVT23 marketing application
Polarean expands Ascend Imaging partnership to boost US market reach
Alto Neuroscience receives FDA Fast Track designation for ALTO-101
Calico Life Sciences' investigational treatment for ADPKD receives US FDA Fast Track Designation
Hologic receives FDA clearance and CE mark for new gastrointestinal bacterial assays
Celltrion launches AVTOZMA IV in the United States following FDA approval
Vanda Pharmaceuticals agrees collaborative framework to resolve US FDA disputes
Microbot Medical secures first Japanese patent for Liberty robotic system following FDA clearance