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Sage seeks to save depression drug; Regeneron aims clinical trial; J&J sets sights for COVID-19 trial

Posted on Mar 19, 2020 by Anuj

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Sage Therapeutics seeking out to save flunked depression drug 

Sage Therapeutics has strategized on how to come back from the phase 3 failure of SAGE-217 in major depressive disorder. The plan focuses on three short-term studies Sage contemplates that may enable it to bring the GABA receptor positive allosteric modulator to market in multiple indications.

SAGE-217, aka zuranolone, failed a phase 3 trial late last year that made Sage halt on other studies as it tried to seek out a path forward for the asset. After having a meeting with the FDA, Sage has planned out an R&D strategy that lies somewhere between the best- and worst-case scenarios that have put forward by analysts.

The plan is to commence three new clinical trials this year for trials of SAGE-217 in the postpartum depression treatment and in two subsets of primary depressive disorder patients, namely those who need acute rapid response therapy or episodic therapy.

Regeneron pharmaceuticals aims summer clinical trial for COVID-19 antibody

Regeneron pharmaceuticals are known to be fast in the development of a promising monoclonal antibody triplet therapy for Ebola outbreak in Congo during 2018. It is under review by the U.S. FDA currently.

Amid the ongoing coronavirus pandemic, the company has geared up again. The scientists of Regeneron have isolated hundreds of neutralizing antibodies against the SARS-CoV-2 virus from a humanized mouse model as well as from humans, who have recovered from COVID-19.

The aim is to choose the superior two antibodies for a cocktail therapy that can either be given to people who are at risk before exposure as a vaccine or as a treatment for those already affected.

Regeneron targets to enter clinical studies by early summer if everything goes as scheduled.

J&J sets sights on November for a COVID-19 vaccine trial

Johnson & Johnson anticipates landing on a COVID-19 vaccine candidate by the end of the month, on the way to the clinical trials in early November. J&J will set up processes for the global production of the vaccine in order to have large quantities available for early next year.

The giant is using the same vaccine platform that was used to develop its Ebola vaccine that will allow it to go very fast and with excellent information.

Johnson & Johnson started work on a COVID-19 vaccine in late January. It would take a parallel approach using at least five different virus constructs that would help it figure out which part of the virus can be used to make an effective vaccine.

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