BioCentury
ARTICLE | Clinical News

May 2 Clinical Quick Takes: Biogen, GSK, Celgene/bluebird, Genkyotex

May 2, 2019 10:52 PM UTC

Biogen's ALS candidate reduces SOD1 protein levels in CSF
Biogen Inc. (NASDAQ:BIIB) will present on May 7 at the American Academy of Neurology meeting the interim Phase I/II data of tofersen that had prompted it to exercise an option to the amyotrophic lateral sclerosis candidate from Ionis Pharmaceuticals Inc. (NASDAQ:IONS). Among ALS patients with a confirmed SOD1 mutation, 100 mg tofersen (formerly BIIB067) significantly reduced SOD1 protein levels in CSF from baseline to week 12 (p=0.002) and showed a trend towards slowing of clinical decline vs. placebo. Biogen started in March the Phase III VALOR trial of the SOD1-inhibiting antisense oligonucleotide to treat ALS with SOD1 mutations, which is a rare subtype of familial ALS that the company said accounts for about 2% of all ALS cases (see "Biogen Opts in for Ionis' ALS Candidate, Plans Pivotal Trial").

GSK asthma therapy meets in Phase III
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) said once-daily Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) met the primary endpoint of improving lung function from baseline to week 24 vs. Relvar Ellipta fluticasone furoate/vilanterol in the Phase III CAPTAIN trial to treat uncontrolled asthma (p<0.001)...