Author Archives: Vanda Pinto PhD

Phase 2 Safety Trial of AT-1501 Nears Full Enrollment of Patients

A Phase 2 study of the investigational antibody AT-1501 in treating amyotrophic lateral sclerosis (ALS) has completed patient enrollment in three of its four dosing groups, and is likely to be fully enrolled by year’s end, its developer, Eledon Pharmaceuticals, announced. A total of 54 ALS patients diagnosed in the…

Clene Soon Will Complete Phase 2 Trial Testing CNM-Au8

Note: This story was updated Sept. 21, 2021, to note that 18% of patients, not 80%, experienced increases in the MUNIX(4) sum score at some point during the study. The last patient visit has been completed in Clene’s Phase 2 trial investigating the potential of CNM-Au8 — which…

Clene Boosts Production Capacity of CNM-Au8

Clene, and its wholly owned subsidiary Clene Nanomedicine, have signed two lease agreements that will more than quadruple the manufacturing capacity of CNM-Au8, their investigational therapy for people with amyotrophic lateral sclerosis (ALS). The first lease is for a 10-year agreement for a 74,210-square-foot building in Elkton, Maryland.

FDA Puts APB-102 Gene Therapy for SOD1 ALS on Fast Track

The U.S. Food and Drug Administration (FDA) has granted fast track status to Apic Bio’s experimental therapy APB-102, designed for amyotrophic lateral sclerosis (ALS) patients who carry mutations in the SOD1 gene that lead to misfolded proteins in cells. This designation accelerates the development of investigational therapies that…

Doddie Foundation Gives £500,000 to Support UK Research Fund

A £500,000 (almost $700,000) grant the My Name’5 Doddie Foundation was given to the LifeArc & MND Association Translational Research Fund to support work that might lead to new treatments for motor neuron diseases (MND), including amyotrophic lateral sclerosis (ALS). The fund, jointly established by LifeArc…

Amylyx Secures Funding for Therapy Candidate AMX0035

Amylyx Pharmaceuticals has raised $135 million to advance the clinical development and the potential launch of its lead candidate AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The Series C financing round, led by Viking Global Investors, also will be used to support further research and…

FDA Grants Orphan Drug Designation to Pridopidine

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Prilenia’s pridopidine for the treatment of amyotrophic lateral sclerosis (ALS). The decision follows a recent positive opinion from a branch of the European Medicines Agency recommending the treatment be given orphan drug status in…