FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
Amyotrophic lateral sclerosis (ALS) is a rare, progressive neurodegenerative disorder caused by loss of upper and lower motor neurons, leading to weakness, muscle wasting, and eventually respiratory failure. It is the most common motor neuron disease.
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
Amylyx is approaching key catalysts ahead of its May 7 earnings report, led by Phase 3 LUCIDITY data for avexitide in post-bariatric hypoglycemia due in the third quarter. The company is also expected to provide updates on AMX0035 in Wolfram syndrome and AMX0114 biomarker data in ALS.
A Delphi consensus of 23 experts identified Zostavax, sildenafil and riluzole as high-priority candidates for Alzheimer disease clinical trials. Caregivers ranked the herpes zoster vaccine highest for acceptability and perceived benefit–risk balance.
CervoMed presents new MRI data showing neflamapimod may reduce basal forebrain atrophy in dementia with Lewy bodies and finalizes Phase 3 trial design. The drug has also been selected for a UK-funded ALS platform trial, with first dosing expected by end of 2026.
NeuroTherapia has completed a Phase 2a trial of NTRX-07 in Alzheimer's patients, meeting safety objectives with no treatment-related serious adverse events. Preliminary biomarker analysis shows encouraging results, including MRI findings trending toward stabilization. The oral small molecule targets neuroinflammation and showed positive effects in animal models.
A phase 3 clinical trial has launched for pridopidine as a potential ALS treatment, while AI research identified 18 FDA-approved drugs that may extend survival. Separate studies found a promising three-drug combination for sporadic ALS using new cell models.
PrimeC, an oral combination therapy, showed safety and signals of clinical benefit in a phase 2b trial, while PLL001, a gut-targeting therapy, demonstrated positive safety and tolerability in a phase I/II study for amyotrophic lateral sclerosis.
Northwestern Medicine scientists discovered that N-acetyl-L-leucine (NALL), an FDA-approved compound, promotes neuroprotective effects in experimental Parkinson's disease models by targeting multiple molecular pathways simultaneously.
Brainstorm Cell Therapeutics announced a $1 million private placement at a premium to market price to support its upcoming Phase IIIb trial of NurOwn stem cell therapy for amyotrophic lateral sclerosis.
Coya Therapeutics detailed plans for a Phase 2 trial of combination immunotherapy targeting neuroinflammation in ALS, following a four-patient study showing biomarker improvements and reported slowing of disease progression.
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