DUBLIN – Ose Immunotherapeutics SA finds itself in the difficult place of hitting the primary endpoint of the first part of a phase III trial of Tedopi, a therapeutic vaccine, in non-small-cell lung cancer (NSCLC) while having to terminate the study without completing the crucial second part.
Akero Therapeutics Inc. rolled out stellar non-COVID-19 (for a change) clinical news with long-acting fibroblast growth factor 21 (FGF21) analogue AKR-001 in biopsy-confirmed nonalcoholic steatohepatitis (NASH), but even in liver disease the pandemic became part of the discussion.
HONG KONG – Phase II data of South Korea-based Qurient Co. Ltd.’s novel antibiotic candidate may offer hope that the first universal regimen to treat tuberculosis (TB) regardless of drug resistance status has been found.
During the conference call on earnings in March, CEO Dror Harats told investors that “the most important thing” about VBL Therapeutics Ltd.’s then-upcoming analysis of interim phase III data with gene therapy VB-111 (ofranergene obadenovec) is that it was “designed in a way that will enable us to tell the market if we are at least as good as what we've seen” in the phase II experiment.
Oncopeptides AB remains on track for an NDA filing in the second quarter for its peptide-drug conjugate, melflufen, in relapsed refractory multiple myeloma (RRMM).
BEIJING – Shanghai Junshi Biosciences Ltd. is developing neutralizing antibodies as a potential treatment for COVID-19, and the program will move on to clinical trials soon. Meanwhile, the biotech is set to launch a pre-revenue IPO on Shanghai’s STAR market.
Despite earlier signs it might meet the primary endpoint of a phase III trial testing its ability to terminate supraventricular tachycardia (SVT) episodes in patients with paroxysmal supraventricular tachycardia (PSVT), a short-acting calcium channel blocker tested by Milestone Pharmaceuticals Inc. failed to do so.
A survey of 149 companies by Tufts Center for the Study of Drug Development found more than two-thirds of clinical trial sponsors were using or piloting at least four different data sources in their clinical trials.
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic.
Stoke Therapeutics Inc. is marching ahead in the second half of this year with its phase I/IIa study with STK-001 in Dravet syndrome (DS), one of the more abysmal forms of epilepsy, although the FDA has temporarily hobbled part B of the test, pending preclinical data that will more fully characterize the safety profile of the antisense oligonucleotide (ASO).
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