The frontrunners--cellulose sulfate, Savvy, PRO 2000 and BufferGel--are all slated to undergo phase III trials
M2 EQUITYBITES-May 14, 2018-AstraZeneca provides update on the GALATHEA phase III trial
Faron has also recently received the second IDMC (Independent Data Monitoring Committee) recommendation to continue the INTEREST pan-European Phase III trial
with Traumakine without any modifications.
Results from all Phase III trials
are due to be reported by the first half of 2012.
The Phase III trial
titled Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft Surgery 2 (PRIMO-CABG2), included approximately 4,250 patients, and compared the safety and efficacy of pexelizumab against that of placebo in reducing heart attack and death following CABG surgery with or without concomitant valve surgery.
Requirements prior to Phase III studies include product manufacturing, an end-of-Phase II meeting with the FDA, and the design of Phase III trials
. It is expected that final decisions about the size, duration, and other attributes of future studies will be made in conjunction with a licensing partner and/or upon meeting with the FDA.
One issue that there appears to be universal agreement on is the importance of participation in clinical trials, specifically randomized phase III trials
. In fact, it was the promising results of phase II trials, which frequently reported results in comparison to historical controls, which prompted randomized trials.
Atogepant appears to be effective in preventing migraines for episodic patients and while the incidence of elevated liver enzymes was balanced between the arms, it is a risk that needs to be studied in larger and longer Phase III trials
, Van Buren tells investors in a research note.
GALATHEA and TERRANOVA are randomised, double-blinded, 56-week placebo-controlled, multi-centre Phase III trials
assessing the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy in comparison to placebo.
The initiation of the Japanese study indicates that the Pan-European and Japanese Phase III trials
combined aim to treat maximum 420 moderate to severe acute respiratory distress syndrome patients, with results likely to be available in 2017-2018.
Sobi is currently recruiting patients for the phase III trials
with its hemophilia drugs rFVIIIFc (Hemophilia A) and rFIXFc (Hemophilia B), developed in cooperation with US partner Biogen Idec Inc (NASDAQ: BIIB).
Specifically, one subject in the phase III trials
experienced elevated liver enzymes (AST, ALT) and total bilirubin.