Sanofi expects to initiate a Phase I/II trial in September 2020, with potential approval in the first half of 2021. Sanofi also signed an agreement with Translate Bio for an mRNA vaccine. A Phase I trial is expected to begin by the end of 2020.
Sinopharm is initiating a Phase III trial, with an unspecified number of patients, in the United Arab Emirates.
Moderna signed an agreement with Catalent to increase capacity for filling vials and packaging doses.
ICER revised its preliminary pricing review for remdesivir on 6/24/2020. ICER has provided two pricing estimates. One is a cost recovery pricing estimate, based on a review of the cost of producing the final finished product and estimated development costs. ICER estimated a cost recovery price of $1,600 for a 10-day course of treatment. Using a threshold price of $50,000 per incremental quality-adjusted life year (and equal value of a life-year gained) and the benefits seen in the Adaptive COVID-19 Treatment Trial (ACTT), ICER estimated a cost-effective price of $4,580 to 5,080 for a 10-day course of remdesivir. ICER also estimated the effect that dexamethasone would contribute and estimated a lower cost-effectiveness price of $2,520 to $2,800 based on non-peer reviewed data from the RECOVERY trial.
In the 105 patient, Phase II, open-label, GRECCO-19 trial (NCT04326790), fewer patients treated with colchicine plus standard of care had a deterioration of 2 points on a 7-grade scale, ranging from able to resume normal activities to death, compared to only standard of care (1.8% vs 14%) in Greek patients hospitalized with COVID-19. The deterioration in the control groups was mainly due to an increased need for mechanical ventilation. Standard of care included hydroxychloroquine or chloroquine plus azithromycin in most patients with some patients also receiving lopinavir, ritonavir, tocilizumab or anticoagulation. There was no difference between groups in peak troponin levels or C-reactive protein, but colchicine did produce a reduction in dimerized plasma fragment D levels, which suggests a possible antithrombotic effect.
An article posted on an editorial server describes compassionate use of opaganib in Israel for the treatment of severe COVID-19 (NCT04435106) in five patients and compared the results to an investigator-selected matched case-control group of 18 patients. All opaganib-treated patients were discharged on room air and none required ventilation, while 33% of standard care patients required mechanical ventilation. All patients in both groups received hydroxychloroquine and most also received azithromycin.
Redhill Biopharm is initiating a 40 patient, Phase IIa U.S. trial (NCT04414618) that will evaluate opaganib in treatment of patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. Redhill is also planning a European, 270 patient, Phase II/III trial.
In a 544 patient, retrospective Italian study, treatment with tocilizumab reduced the risk of mechanical ventilation or death, but had a higher incidence of new infections compared to standard of care alone after the patient sample was adjusted for sex, age, recruiting center, duration of symptoms, and Sequential Organ Failure Assessment (SOFA) score. Standard of care in Italy at the time of the study (February 21 to April 30, 2020) included treatment with oxygen, hydroxychloroquine, azithromycin, lopinavir–ritonavir or darunavir–cobicistat, and low molecular weight heparin.