New T1DM Teplizumab Pivotal Ph3 trial (PROTECT)

FENIX has observed a new teplizumab pivotal Ph3 trial (PROTECT) on CT.gov. Teplizumab is an anti-CD3 monoclonal antibody being studied for new-onset T1DM. Of note, the initiation of this pivotal trial is earlier than the previous guidance from Provention Bio (previously late 2019). Below, FENIX provides thoughts on this new trial in the context of the failed Ph2/3 PROTÉGÉ study for teplizumab when the compound was under the control of Macrogenics.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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