Daily Top News – July 2, 2020

Sarconeos (BIO101) / BiophytisBiophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure (Reuters) - Jul 2, 2020 - "Biophytis SA...today announces that the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to proceed with its clinical development program COVA. This Phase 2/3 program will assess Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19....'We have already initiated the work to start this key Phase 2/3 trial as soon as possible in the US, and in the European countries where we received approval, and will update the market shortly on our planned timelines.'"Sylvant (siltuximab) / BeiGene, JazzEUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome (Businesswire) - Jul 2, 2020 - "EUSA Pharma...today announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS)....The multicentre trial will aim to enrol approximately 400 patients with viral ARDS and elevated serum levels of IL-6."Erbitux (cetuximab) / Eli Lilly, EMD Serono; MEN1611 / MenariniMenarini Ricerche announces C-PRECISE-01, a new phase Ib / II study with MEN1611 in colorectal cancer (PRNewswire) - Jul 2, 2020 - "Menarini Ricerche...announced today that the company will launch a new Phase Ib / II trial with MEN1611 in the second half of 2020...The new study, called C-PRECISE-01, will evaluate MEN1611 and cetuximab in patients with PIK3CA mutant, RAS and RAF wild-type metastatic colorectal cancer (mCRC)....The design of the study will be presented on the virtual ESMO World Congress 2020 for gastrointestinal cancer from July 1st to 4th...The primary goal of the C-PRECISE-01 study is to determine the combination RP2D and to evaluate the anti-tumor activity of MEN1611..."