Pharma COVID Roundup: News from Novartis, NIH, Gilead, GSKBy
The latest on manufacturing and potential treatments for COVID-19 with news from Novartis, the National Institutes of Health, Gilead, GSK, Congress, Inovio, and Cipla.
News from Novartis, NIH, Gilead, GSK, Congress
Novartis Discontinues Trial of Hydroxychloroquine for COVID-19
Novartis has decided to stop and discontinue its sponsored clinical trial of hydroxychloroquine (HCQ) for COVID-19 due to what the company says are “acute enrollment challenges that have made trial completion infeasible.”
Novartis says the recruitment challenge has made it unlikely that the clinical team will be able to collect meaningful data in a reasonable timeframe to determine the effectiveness of HCQ in treating patients with COVID-19. No safety issues have been reported, and there are no conclusions on efficacy from the study.
Novartis says it will continue to supply HCQ for ongoing investigator-initiated trials and upon government requests, where certain conditions are met and the medicine is used in accordance with a nationally endorsed treatment protocol. Researchers at Novartis continue to monitor ongoing guidance from health authorities on the further study of HCQ for COVID-19, as well as the decision by the US Food and Drug Administration to stop the emergency use authorization of HCQ for COVID-19 treatment.
Hydroxychloroquine is a drug approved for treating malaria, lupus, and rheumatoid arthritis that is being evaluated to treat COVID-19.
NIH Halts Clinical Trials for Hydroxychloroquine for COVID-19
The National Institutes of Health (NIH) in the US has stopped a clinical trial of hydroxychloroquine, a drug approved for treating malaria, lupus, and rheumatoid arthritis that is being evaluated to treat adults hospitalized with COVID-19.
A data and safety monitoring board determined that while there was no harm, the drug was unlikely to be beneficial to hospitalized patients with COVID-19. After its fourth interim analysis, the data and safety monitoring board recommended to the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH, to stop the study, which it has done.
Source: National Institutes of Health
Gilead To Start Phase I Trial for Inhaled Version of Remdesivir for COVID-19
Gilead Sciences plans to start clinical trials of an inhaled version of remdesivir, an investigational antiviral drug being evaluated for treating COIVD-19. Daniel O’Day, Gilead’s CEO and Chairman, made the announcement in a June 22, 2020 statement.
Remdesivir is currently being evaluated in clinical trials for treating COVID-19 through intravenous administration. The inhaled formulation would be given through a nebulizer, which could potentially allow for administration outside a hospital setting and at earlier stages of the disease.
The company says it began screening healthy volunteers for Phase I trials of the inhaled version earlier this week (as reported on June 22, 2020) with hopes to begin studies in patients with COVID-19 in August (August 2020).
As part of its next part of clinical development of evaluating remdesivir in COVID-19, O’Day says the company will study remdesivir in treating the disease earlier in progression, in combination with other therapies, and in additional patient groups.
The company says it will conduct trials using intravenous infusions in outpatient settings, such as infusion centers and nursing homes. Gilead says it is also exploring whether it can improve patient outcomes by combining remdesivir with other therapies.
Over the coming months (as reported on June 22, 2020), O’Day says the company will see results from studies of remdesivir with two immune modulators. One study is looking at remdesivir with the JAK inhibitor, baricitinib, and a second is studying remdesivir in combination with the IL-6 receptor antagonist, tocilizumab.
Source: Gilead Sciences
GSK, Clover Begin Clinical Trials for COVID-19 Vaccine Candidate
GlaxoSmithKline (GSK) and Clover Biopharmaceuticals, a Chengdu, China-based biopharmaceutical company, have entered human clinical trials for their adjuvanted COVID-19 vaccine candidate. Clover announced the initiation of a Phase I clinical study evaluating the company’s COVID-19 S-Trimer vaccine (SCB-2019) in combination with GSKs pandemic adjuvant system.
Preliminary safety and immunogenicity results for a Phase I study are expected in August 2020. In parallel, the planning for a global Phase IIb/III vaccine efficacy trial has begun, with initiation targeted later in 2020.
Congress Seeks Info on US Gov’t COVID-19 Vaccine Development Plans
Three members of the US House of Representatives—Carolyn B. Maloney (D-NY), Chairwoman of the Committee on Oversight and Reform; Raja Krishnamoorthi (D-IL), Chairman of the Subcommittee on Economic and Consumer Policy; and James Clyburn (D-SC), Chairman of the Select Subcommittee on the Coronavirus Crisis—sent a letter to Stephen Hahn, Commissioner of the US Food and Drug Administration (FDA), to seek information on the processes that will guide the FDA in its decisions about the development, review, and deployment of any eventual coronavirus vaccines. The Representatives also specified that any potential COVID-19 vaccine needs to be tested to be safe and effective in a complete Phase III clinical trial with at least 30,000 volunteers as per a recommendation by the National Institutes of Health Director, Frances Collins. The House Committee on Oversight and Reform is scheduled to hold a briefing with the FDA on July 2, 2020.
News from Inovio and Cipla
Inovio Receives $71-M US Gov’t Contract for COVID-19 DNA Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has received $71 million in funding from the US Department of Defense (DoD) to support the large-scale manufacture of the company’s proprietary vaccine-delivery devices (Cellectra 3PSP smart device) and the procurement of Cellectra 2000 devices, which are used to deliver INO-4800, Inovio’s DNA vaccine candidate being developed to protect against SARS-CoV-2, the virus that causes COVID-19.
Cellectra 3PSP, a portable and hand-held device, is designed to deliver INO-4800 directly into the skin. Interim results of Phase I clinical studies of INO-4800 in the US will be available later this month (June 2020). A Phase II/III efficacy trial is planned to begin this summer (July/August 2020).
The DoD contract builds upon two separate prior $5-million grants from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines, to accelerate the testing of Cellectra 3PSP. Initial development of the Cellectra 3PSP smart device began in 2019 with $8.1 million in funding from the medical arm of the US Defense Threat Reduction Agency’s Medical CBRN Defense Consortium.
Cipla Receives Approval to Launch Remdesivir for COVID-19 in India
Cipla, a Mumbai, India-based pharmaceutical company, has been granted regulatory approval by the Drug Controller General of India (DCGI) to launch in India Gilead Sciences’ antiviral drug, remdesivir, for treating COVID-19 under Cipla’s brand name Cipremi.
The US Food and Drug Administration issued an emergency use authorization of remdesivir for the treatment of hospitalized COVID-19 patients. In May (May 2020), Gilead Sciences extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir, Cipremi.
Cipla has been granted regulatory approval by the DCGI for restricted emergency use in the country as part of the accelerated approval process. As part of a risk-management plan, Cipla says it will provide training on use of the drug and informed patient consent documents and conduct post-marketing surveillance and a Phase IV clinical trial on Indian patients.
Cipla will be commercializing remdesivir through its own facilities and partnered sites. The drug will be supplied through government and open market channels.