Aug. 5 Clinical Quick Takes: Emgality meets for migraine with treatment failures; plus Verona, Alkahest-Grifols, Squarex and Denali- Sanofi

Emgality meets in Phase III in pretreated migraine patients
Eli Lilly and Co. (NYSE:LLY) reported that anti-CGRP mAb Emgality galcanezumab-gnlm met the primary endpoint in the Phase III CONQUER trial, reducing migraine headache days by 4.1 vs. 1 for placebo (p<0.0001), to treat chronic or episodic migraine patients who have failed on two to four categories of standard-of-care therapies. Lilly markets Emgality to prevent both types of migraines and to treat episodic cluster headaches. The drug is competing with anti-CGRP mAbs from Amgen Inc. (NASDAQ:AMGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv; TEVA) (see "Amgen Still Head of Class in CGRP-migraine").

Verona's COPD therapy meets in Phase II
Verona Pharma plc (LSE:VRP; NASDAQ:VRNA) said its dry powder formulation of ensifentrine (RPL554) met the primary and secondary endpoints in a Phase II trial for maintenance treatment of chronic obstructive pulmonary disease (COPD). On the primary endpoint evaluating lung function, the four doses, from highest to lowest, of the dual PDE-3 and PDE-4 inhibitor therapy led to peak forced expiratory volume in 1 second (FEV1) measurements of 260 mL, 180 mL, 175 mL and 102 mL higher than placebo (p<0.0001 for all four doses). In January, Verona reported a Phase II failure in the indication for nebulized ensifentrine. ...