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ARTICLE | Clinical News

Aug. 28 Clinical Quick Takes: InDex's cobitolimod hits Phase IIb endpoint in UC; plus AstraZeneca and Mitsubishi

August 28, 2019 11:42 PM UTC

InDex's UC therapy heading for Phase III
InDex Pharmaceuticals Holding AB (SSE:INDEX) is planning Phase III testing of cobitolimod after the DNA-based immunomodulatory sequence (DIMS) therapy met the primary endpoint in the Phase IIb CONDUCT study to treat ulcerative colitis in patients who do not respond to conventional therapies. The study's highest dose of the toll-like receptor 9 (TLR9) agonist significantly improved clinical remission rates vs. placebo (p=0.0495). InDex added SEK1.28 (16%) to SEK9.40 on Tuesday.

AZ's triple combo for COPD outperforms doublets
AstraZeneca plc (LSE:AZN; NYSE:AZN) said two doses of Breztri Aerosphere (formerly PT010) each led to significantly lower rates of exacerbations compared with two doublet therapies in the Phase III ETHOS trial to treat chronic obstructive pulmonary disease. The study evaluated Breztri Aerosphere, which is a fixed-dose triple combination that includes budesonide, glycopyrronium and formoterol fumarate, vs. the pharma's Bevespi Aerosphere glycopyrronium/formoterol fumarate and PT009 budesonide/formoterol fumarate. Breztri Aerosphere is approved in Japan and is under review in China, the U.S. and Europe. If FDA approves it, AZ would owe a $150 million milestone to shareholders of Pearl Therapeutics Inc., which it acquired in 2013 (see "AZ COPD Combo Heading for Submissions")...