COVID-19 roundup: New immune targets to address pandemic; plus updates from CanSino, Arcturus, Fujifilm and more
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At least three new treatments for the inflammatory complications of SARS-CoV-2 infection, each with a target new to clinical COVID-19 countermeasures, have or will soon enter human studies. Movement on other fronts against the pandemic included advancement of COVID-19 vaccine candidates from CanSino and Arcturus and a clinical trial of Fujifilm’s antiviral.
Biohaven Pharmaceutical Holding Co. Ltd. (NYSE:BHVN) and CalciMedica Inc. each gained FDA’s permission to conduct a Phase II trial addressing inflammation due to SARS-CoV-2 infection.
Biohaven will collaborate with Thomas Jefferson University to evaluate migraine therapy vazegepant to treat excessive lung inflammation caused by SARS-CoV-2 infection in patients who need supplemental oxygen. The double-blind study of the intranasal small molecule CGRP receptor antagonist will begin within weeks.
Biohaven said that acute lung injury induces the release of CGRP, which in turn is implicated in symptoms such as cough, fever, pain and release of the inflammatory cytokine IL-6.
CalciMedica Inc. will test CM4620-IE in patients with severe COVID-19 pneumonia who are at risk for progressing to acute respiratory distress syndrome (ARDS) in an open-label trial. The company said the small molecule CRAC inhibitor has demonstrated potential efficacy in patients with hypoxemia secondary to systemic inflammatory response syndrome due to acute pancreatitis.
Meanwhile, MediciNova Inc. (NASDAQ:MNOV; Tokyo:4875) announced plans for a clinical trial of Ketas ibudilast, a MIF, PDE-4 and PDE-10 inhibitor, to treat ARDS caused by COVID-19. The study evaluating the oral anti-inflammatory will be conducted by Yale University’s Advanced Therapies Group.
CanSino, Arcturus vaccines
Preliminary safety data from a Phase I trial of its COVID-19 vaccine prompted CanSino Biologics Inc. (HKEX:6185) to plan a Chinese Phase II trial, starting soon.
CanSino co-developed Ad5-nCoV with the Academy of Military Medical Sciences. The candidate is an adeno-associated virus serotype 5 (AAV5) vector encoding the SARS-CoV-2 spike protein.
CanSino is backed by Qiming Venture Partners, which closed on Wednesday a $1.1 billion China-focused fund (see “Qiming Readies to Deploy New China Fund”).
Including CanSino’s, there are at least eight COVID-19 vaccines in the clinic, according to BioCentury’s COVID-19 Resource Center.
Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) hopes to join that group with a trial start planned for this summer of its LUNAR-COV19 mRNA vaccine. The Singapore trial will enroll 76 volunteers to receive the vaccine, which Arcturus developed with Duke-NUS Medical School and its genetic correlation system.
Arcturus said in vitro data of LUNAR-COV19 show the vaccine can generate effective expression of the SARS-CoV-2 spike protein. The initial GMP batch of vaccine will be delivered in June.
Fujifilm brings flu therapy to U.S.
Fujifilm Holdings Corp. (Tokyo:4901) started a U.S. Phase II trial of its flu drug favipiravir to treat COVID-19.
The trial, which will enroll 50 patients, will be conducted with Brigham and Women’s Hospital, Massachusetts General Hospital and the University of Massachusetts Medical School.
Favipiravir, approved as Avigan in Japan, inhibits RNA polymerase necessary for influenza virus replication.
Fujifilm started a Japanese Phase III trial of favipiravir on March 31.
The antiviral, which researchers have recommended be included in China’s treatment guidelines for COVID-19, improved lung symptoms in 91% of patients vs. 62% of control patients, according to a March report from the Third People’s Hospital of Shenzhen (see “COVID-19 Roundup”).
NIH hydroxychloroquine trial under way
NIH has enrolled the first COVID-19 patients at the Vanderbilt University Medical Center in a placebo-controlled trial of hydroxychloroquine.
The malaria drug has been touted by President Donald Trump as a COVID-19 therapeutic “sent from heaven;” however, efficacy data for the therapy, which has well-documented toxicities, have been inconclusive (see “Debate Over Malaria Drugs for COVID-19 Illustrates White House Conflicts”).
The blinded, placebo-controlled, randomized clinical trial aims to enroll more than 500 adults hospitalized with COVID-19, or in an emergency department with anticipated hospitalization.
The ORCHID study is being conducted by the NIH’s Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network within the National Heart, Lung and Blood Institute.
Convalescent plasma donor screen
Chembio Diagnostics Inc. (NASDAQ:CEMI) announced Stony Brook University will use its DPP COVID-19 point-of-care serological test to identify recovered COVID-19 patients for convalescent plasma donations. The assay will determine if a potential donor’s anti-SARS-CoV-2 IgG titers are high enough for use in a randomized, controlled study evaluating convalescent plasma as a treatment for hospitalized COVID-19 patients.
Chembio’s test, which detects IgM and IgG, can give results in 15 minutes.
Beat19’s call to action
xCures Inc. has launched Beat19, a real-world data study that aims to track the course of COVID-19 infection and generate a natural history for different patient populations. Beat19 plans to enroll 100,000 people to provide medical history, medications, and daily information about environment, activities, symptoms and medication use to detect signals of what may modify the trajectory or risk of infection.
Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.
CGRP - Calcitonin gene-related peptide
CRAC - Calcium release-activated calcium channel
IL-6 - Interleukin-6
MIF - Macrophage migration inhibitory factor
PDE-4 - Phosphodiesterase-4
PDE-10 - Phosphodiesterase-10