BioCentury
ARTICLE | Product Development

Sept. 8 Quick Takes: Phase III wins for Albireo, Merck and Spero; plus Corbus, Blueprint, AnHeart, Grifols-Alkahest, and Exelixis-NBE

September 9, 2020 1:52 AM UTC

Albireo gains on Phase III rare liver diseases readout 
Albireo Pharma Inc. (NASDAQ:ALBO) gained $12.25 (45%) to $39.62 on Tuesday after announcing odevixibat met its two primary endpoints in the Phase III PEDFIC 1 study for progressive familial intrahepatic cholestasis. The non-systemic ileal bile acid transport inhibitor increased positive pruritis assessments over placebo (53.5% vs. 28.7%) to meet the U.S. primary endpoint and reduced serum bile acid responses by 70% or to a level of 80 µmol/L — the EU primary endpoint — in 33.3% of patients compared with no patients from the placebo arm. The company plans to submit regulatory filings by early next year.

Merck’s gefapixant meets in Phase III for refractory chronic cough
A 45 mg dose of P2X3 receptor agonist gefapixant (MK-7264) from Merck & Co. Inc. (NYSE:MRK) met the primary endpoint in a pair of Phase III trials for refractory chronic cough, decreasing 24-hour cough frequency by 18.45% over placebo at 12 weeks in the COUGH-1 trial and by 14.64% at 24 weeks in the COUGH-2 study. The data were presented at the Virtual European Respiratory Society (ERS) International Congress 2020...