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Regeneron Races Into Phase III Trial Of Antibodies To Block Coronavirus Infection

Regeneron Pharmaceuticals, Inc. and the National Institute of Allergy and Infectious Diseases (NIAID) have launched a Phase III study of REGN-COV2, a cocktail of antibodies which could prevent infection from the novel coronavirus.

The Tarrytown, NY-headquartered company is one of several companies investigating the potential of monoclonal antibodies as a COVID-19 treatment, but now becomes the first to launch a trial examining their potential to prevent infection by SARS-CoV-2 in those exposed to it.

AbCellera Biologics Inc. and Eli Lilly and Company were the first to launch a Phase I trial of a single antibody treatment on 1 June to treat patients already infected, with Regeneron announcing a similar trial using REGN-COV2 just 10 days later.

But now Regeneron and NIAID have moved with great speed into studying REGN-COV2 as a prophylaxis in a Phase III trial, using adaptive trial design to accelerate progress, and also moving its therapy trial into a Phase II/III stage.

The trial has been launched as the US reels from an alarming new upsurge in COVID-19, with the rate of infections rising in 32 states and total confirmed cases in the country now exceeding 3 million. The hope is that the antibody therapies can potentially provide passive immunity and block transmission of the virus, which could help buy time while the first vaccines are developed.

Announcing the trial start, Regeneron's chief scientific officer George Yancopoulos said the drug could be available for the prevention of COVID-19 “much sooner than a vaccine.”

The study will look at the antibody cocktail's ability to prevent COVID-19 infection in 2,000 people in the US who have had close exposure to a COVID-19 patient, such as a member of the trial participant’s household. The trial will assess participants’ SARS-CoV-2 infection status.

All the trials are adaptively designed, which means the ultimate numbers of patients enrolled will depend on trial progress and insights from Phase II treatment studies, and could allow the trials to be stopped early if they produce robust data.

"We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic," said Yancopoulos.

REGN-COV2 combines two antibodies discovered after Regeneron evaluated fully-human antibodies produced by the company’s VelocImmune mice and antibodies generated by humans who recovered from COVID-19. The same technology platform was used to discover the three-antibody cocktail REGN-EB3 that is under US Food and Drug Administration review for the treatment of Ebola virus.

Other companies also fast-tracking antibodies therapies against COVID-19 include AstraZeneca PLC and Vir Biotechnology, Inc. and GlaxoSmithKline plc (Also see "Antibody Drugs Could Be Next COVID-19 Milestone" - Scrip, 4 May, 2020.)

Regeneron has also aimed to address the pandemic with partner Sanofi with their interleukin-6 (IL-6) inhibitor Kevzara (sarilumab). However the companies recently reported that Kevzara did not significantly improve the condition of COVID-19 patients who require mechanical ventilation in a Phase III study. (Also see "Coronavirus Update: Moderna Hold Up, Sanofi and Regeneron's Kevzara Fails In Phase III" - Scrip, 3 Jul, 2020.)


Mylan Gets Go-Ahead For Remdesivir In India

Weeks after Hetero Drugs Ltd. and Cipla Limited announced the launch of their generic remdesivir products in India for the treatment of COVID-19, another Gilead Sciences, Inc. licensee, Mylan N.V., has indicated that its version is on the way too. (Also see "Hetero, Cipla's Remdesivirs Hit India Market, 'Surplus' Envisaged By August" - Scrip, 22 Jun, 2020.)

Mylan, a long-standing Gilead partner, has now received regulatory approval from the the Drugs Controller General of India for its remdesivir 100mg/vial (to be sold as Desrem) for restricted emergency use in the country, as part of the accelerated approval process to address urgent unmet needs amid COVID-19. Remdesivir is the tenth medicine licensed to Mylan by Gilead, following their first deal in 2006 for the HIV drug tenofovir disoproxil fumarate.

Desrem will be available to patients this month and has been priced at INR4,800 ($64) which is more or less in the price range set by the Indian licensees. Hetero’s Covifor is priced at around INR5,400 per vial, while Cipla’s Cipremi is priced at “less than INR5,000” per vial. (Also see "Hetero Head On Remdesivir Partnering, Royalty Model" - Scrip, 15 May, 2020.)

Mylan, however, underscored that Desrem comes at over 80% less than the price at which the branded version of the product will be available to governments in the developed world. Gilead recently indicated that its own product Veklury (remdesivir) will cost $390 per vial for government payers in developed countries and $520 for commercial payers in the US.

Veklury recently received conditional approval in the European Union. (Also see "Gilead Sets Remdesivir Price, Commits Nearly All Near-Term Supplies To US" - Scrip, 29 Jun, 2020.) (Also see "Amid Supply Concerns, EU Approves Gilead’s Remdesivir" - Scrip, 3 Jul, 2020.)

Mylan expects to manufacture remdesivir in India at its injectables sites, which also make products for the US and have been inspected by the US Food and Drug Administration for compliance with good manufacturing practices. It is also working toward expanding emergency use access for patients in all the low- and middle-income countries, licensed by Gilead to do so, subject to reviews by national regulatory bodies and the prequalification program of the World Health Organization.

Gilead had earlier sealed non-exclusive, voluntary licensing agreements with five generic firms in India and Pakistan, including Hetero, Cipla and Mylan, to manufacture remdesivir for distribution in 127 countries. (Also see "Gilead Licensing Deal Expands Remdesivir Access, Capacity" - Scrip, 13 May, 2020.)

Recently, Gilead expanded its list of licensees for remdesivir to include Dr. Reddy's Laboratories Ltd.SyngeneZydus Cadila. flagship Cadila Healthcare and Egypt's Eva Pharma. The Indian approval for Desrem marks the first clearance for Mylan in these 127 markets.

The go-ahead for Desrem also comes amid speculation of a temporary shortage of supplies of remdesivir in India, with indications of some delays in raw material arrivals; this against the backdrop of the ongoing readiness of firms from Bangladesh to step in with supplies, though it's not immediately clear how the situation could play out. (Also see "India Remdesivir Supplies: 'Peculiar' Situation, Flip Flops And Bangladesh Touch" - Scrip, 11 Jun, 2020.) 

There are also local media reports that suggest that some patients on the antiviral have reported liver damage, with India’s health ministry apprised of the situation, though no official word was immediately available on any potential action.


Sinovac's CoronaVac Approved For Pivotal Phase III Trial In Brazil

China’s Sinovac Biotech Ltd. has announced that its previously announced partnership with Brazilian immunobiologics and vaccines firm Instituto Butantan has led to the Brazilian regulatory agency Anvisa granting approval for a pivotal Phase III trial, sponsored by Butantan, for the inactivated COVID-19 vaccine developed by Sinovac's subsidiary Sinovac Life Sciences Co., Ltd.

The agency fast-tracked the application, which took only around two weeks to conclude. The clinical study will recruit nearly 9,000 healthcare professionals working in COVID-19-specialized facilities in 12 sites across Brazil; enrollment is scheduled to start this month after ethical approvals. 

Sinovac Life Sciences initiated development of the vaccine, branded CoronaVac, in late January and preclinical results have been published in Science. China approved Phase I/II studies in mid-April in more than 700 healthy adults and preliminary results were recently reported, showing more than 90% seroconversion 14 days after a two-dose schedule.  (Also see "Coronavirus Update: Sinovac Latest To Report Vaccine Success In Humans" - Scrip, 15 Jun, 2020.)

A Phase II study in elderly adults is ongoing which will be followed by child and adolescent groups, and the Phase II program is currently expected to be completed at the end of 2020. Sinovac has already partnered with several companies outside of China for Phase III efficacy studies.


Zydus Cadila To Conduct COVID-19 Clinical Trials For Desidustat

Zydus group’s Cadila Healthcare will conduct Phase IIb trials for its new chemical entity desidustat against COVID-19 and has received approval from Mexico’s regulatory authority, the Commission for the Protection against Sanitary Risk (COFEPRIS), for a clinical trial.

The novel oral hypoxia-inducible factor prolyl hydroxylase inhibitor has shown a good safety profile so far in two Phase III trials conducted on chronic kidney disease patients. It’s also being explored in the US for myelodysplastic anemia and chemotherapy-induced anemia.

Cadila Healthcare has tied up with Avant Santé Research Center S.A. de C.V., a contract research organization headquartered in Monterrey, Mexico, for the purpose. Plans are to conduct a multicenter, comparator-controlled study, with 100mg tablets of desidustat being administered for 14 days along with recommended standard care.

Managing director Sharvil Patel had first spoken about exploring the use of desidustat in moderate cases of COVID-19 during a call detailing the company’s fourth quarter performance on 19 June.  (Also see "Zydus Cadila To Enter Remdesivir Fray In India By End-July" - Scrip, 23 Jun, 2020.) 

Patients infected with COVID-19 have been reported to display signs of hypoxia leading to organ failure and death despite the use of antivirals, anti-inflammatory drugs or ventilators. Due to reduced quantities of hemoglobin to carry oxygen and carbon dioxide, lung cells develop extremely intense poisoning and inflammation, which eventually results in ground-glass-like lung images.

Desidustat mimics the physiologic effect of altitude on oxygen availability, which can lead to increased red blood cell production and improved oxygen delivery to tissues.

Meanwhile, the company’s other COVID-19 candidates – a DNA vaccine and pegylated interferon alpha-2b – are also being fast-tracked. It recently received approval from the Indian regulator, the Drugs Controller General of India, for clinical trials of the second drug.

At the forefront of the battle against the novel coronavirus SARS-CoV-2, both by design and default, Cadila is also seen benefiting from the recent pronouncement by the University of Oxford that dexamethasone, a product Cadila currently produces, lowers mortality in severe cases of COVID-19.  (Also see "Is Dexamethasone The Next HCQ For Indian Pharma?" - Scrip, 19 Jun, 2020.) 

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