Clinical research
Auris Medical Holding Ltd., a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, announced that the first patient has been randomized in its “TRAVERS” Phase 2 trial of AM-125, the Company’s investigational drug for the treatment of acute vertigo.
Biogen and Alkermes announced positive topline data from EVOLVE-MS-2, a Phase III trial of diroximel fumarate for relapsing-remitting multiple sclerosis compared to Tecfidera.
The DMC recommended the trial continue without changes in order to determine other dual-primary endpoints, such as event-free survival.
We embarked upon the landmark Phase III PARAGON-HF trial to determine whether sacubitril/valsartan could have a meaningful impact on the treatment of HFpEF, as it does in the treatment of heart failure with reduced ejection fraction,” stated John McMurray, professor of Medical Cardiology at University of Glasgow and PARAGON-HF Executive Committee Co-Chair.
A number of companies reported clinical trial data last week. Here’s a look.
Janssen will present data from the trial at a September conference in Stockholm. The company plans to seek FDA approval later this year.
Evotec SE announced that the Company has been informed by Bayer about positive Phase IIa results from a study surveying the safety, efficacy and dosage of the compound BAY1817080 in refractory chronic cough.
FGFR inhibitor gains FDA approval based on 40% response rate in MD Anderson-led Phase II trial
A combination of Opdivo and Yervoy hit the primary endpoint in NSCLC patients with PD-L1 expression. Opdivo and chemotherapy did not demonstrate efficacy in patients regardless of PD-L1 expression.
With the positive results from this trial, as well as an earlier Phase III trial, Myovant Sciences plans to seek regulatory approval later this year.
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