In early January 2020, a virus was sequenced and recognized as a novel coronavirus. It was named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which is the cause of COVID-19. By March 2020, the WHO declared COVID-19 as a pandemic with the current numbers of confirmed cases of COVID-19 reaching 3,024,059 (as at 8:00 AM CEST, 30 April 2020), including 208,112 deaths.
There are many healthcare organizations, along with biotech and pharma companies, that are conducting and supporting research for medical developments to treat SARS-CoV-2-induced disease. At this time, urgent public health measures are required to control the spread of the coronavirus.
Scientists all over the world are racing against the clock to develop an effective treatment option for patients suffering from coronavirus. Everyone is frustrated with the coronavirus crisis and wants to hear that a vaccine for coronavirus has been successfully developed. In this attempt, a US-based biopharmaceutical company, Gilead Sciences, seems to offer a ray of hope amid this chaos. The new information from the clinical trial being conducted Gilead provides a glimmer of hope.
Let us delve and discuss how Gilead is working progressively towards developing COVID-19 treatment and what could be the other potential treatments for this deadly disease in the future:
About Gilead Sciences
California, US-headquartered, research-based biopharmaceutical player Gilead Sciences Inc (NASDAQ:GILD) is engaged in the development as well as commercialization of innovative medicines for the unmet medical need. The company endeavors to transform and simplify to cater to individuals across the world having life-frightening diseases. GILD has its operations in over 35 nations across the globe.
What Does the Study Data Reveal?
Gilead Sciences has revealed that it has reported positive data from the SIMPLE trial which is an open-label, Phase III study for assessing dosing durations of 5-day and 10-day for remdesivir (investigational antiviral drug) in hospitalized patients having severe COVID-19 manifestations.
The trial showed that patients administering a 10-day treatment regimen of remdesivir attained similar progress in clinical condition as compared with the patients who are on a 5-day treatment regimen.
Moreover, Gilead Sciences stated that these study results complement data from a study of investigational antiviral Remdesivir for COVID-19 by NIAID (National Institute of Allergy and Infectious Diseases).
This study was conducted to ascertain whether a 5-day course of remdesivir would accomplish comparable efficacy outcomes as the 10-day dosing regimen that is used in several ongoing studies.
In the open-label, Phase 3 clinical trial, the patients who are hospitalized with severe COVID-19 infection attained a similar improvement in the clinical result, whether they are on a 5-day or 10-day treatment course of remdesivir.
The scientist stated that over 50% of the patients in both groups were released from the hospital within fourteen days. About 64.5% of the patients who were treated with the 5-day treatment course have recovered, in comparison to 53.8% of the group who were on a 10-day treatment regimen.
Also, the Company highlighted that the clinical outcomes varied by geography. The overall mortality rate outside Italy on Day 14 was 7% in the two treatment groups. Nearly 64% of patients witnessed clinical improvement and 61% were cleared from the hospital. Notably, Gilead stated that the Company intends submission of complete information for publishing in a peer-reviewed journal in the upcoming weeks.
SIMPLE Trials Initiated by Gilead
The Company disclosed that it had commenced two clinical studies which are randomized, open-label, multi-center Phase III clinical studies for remdesivir, named as SIMPLE trials, in nations where there is a high occurrence of COVID-19 infection.
- The first trial is for assessing the safety as well as the efficacy of dosing regimens (5-day and 10-day) of remdesivir in the hospitalized patients having serious COVID-19 manifestations.
- The second trial is also for evaluation of the safety and efficacy with the same dosing durations of intravenous remdesivir in patients having mild to moderate symptoms of COVID-19, compared with the standard of care. The findings from the first 600 patients of this trial are anticipated at the end of May.
Gilead’s shares climbed 5.68% on 29 April 2020 to close at US$83.14. The stock has a market capitalization of US$104.6 billion with a P/E ratio of nearly 19.75%.
Brief About Remdesivir
Remdesivir is an investigational antiviral drug which has been previously tested against Ebola, Marburg, MERS and SARS. The in-vitro testing of remdesivir by Gilead demonstrated the activity of the drug against SARS-Cov-2 virus. Remdesivir is under evaluation in multiple ongoing Phase 3 trials for its efficacy and safety.
Clinical trials of Remdesivir
The clinical trials of remdesivir started two months ago. Gilead stated that while it can take one year or more to have the first clinical information for an investigational therapy, it is notable that the Company anticipates having the earliest remdesivir trial data so quickly.
There are Currently Seven Remdesivir trials Going On to Expedite Testing
Seven ongoing clinical trials have been initiated for determining whether remdesivir is a safe and effective treatment for COVID-19, and every trial is set up at an unprecedented pace.
Ongoing and Upcoming projected Data for Investigational Drug of Gilead for COVID-19:
Remdesivir Wins the Race to Stop COVID-19
Currently, many other possible therapies for the COVID-19 are under investigation. Some of the therapies include remdesivir, tocilizumab, hydroxychloroquine and convalescent plasma which would have been not known to most folks outside of the medical field. Until now, only remdesivir out of these drugs has demonstrated a potential effect on the symptoms of COVID-19.
A few days earlier, the Food and drug administration (FDA) stated that hydroxychloroquine and chloroquine were not shown to be safe and effective for preventing or treating the symptoms of COVID-19.
Recent Trends Related to COVID-19 Treatment
The healthcare sector is in a race to develop a treatment for the deadly COVID-19, and many biotech and healthcare industries across the world are conducting clinical trials.
Let us have a look at the upcoming trends which could prove a proper treatment for the coronavirus infection:
Arthritis drug shows 'significant' potential and may help fight COVID-19
An arthritis drug, tocilizumab has demonstrated early potential in the prevention of extreme inflammation in patients having COVID-19 symptoms, as per a French clinical trial which was carried out by the Paris public hospitals (AP-HP) group.
The trial included 129 hospitalized patients with moderate or acute viral pneumonia, which happens in 5-10% of COVID-19 patients.
This treatment was found to reduce the number of fatalities or life support interventions substantially.
Trimer-Tag© technology: Trial to Launch in Perth
An Australian clinical research firm, Linear Clinical Research is prepared to trial a potential vaccine based on Trimer-Tag© technology to combat COVID-19 and disclosed that it would be looking for volunteers in the next two months. The trial would be on a 'ground-breaking' potential vaccine that has been developed to support the production of antibodies in the human body to fight the coronavirus infection.
Moreover, the Coalition for Epidemic Preparedness Innovations (CEPI) would invest nearly US$3.5 million in Clover Biopharmaceuticals Australia for developing the vaccine against the infectious disease. This investment will aid the Company’s attempt to commence the Australian Phase 1 clinical study for the S-Trimer vaccine candidate.
The vaccine candidate is centered on the proprietary Trimer-Tag vaccine technology platform of Clover. If found to be effective in clinical studies, Clover can quickly scale up the manufacturing of the vaccine.
Mesoblast to Commence Enrollment for Phase 2/3 trial of Remestemcel-L
After reporting 83% survival in ventilator-dependent COVID-19 patients (10 out of 12) Mesoblast Limited (ASX:MSB) revealed that the Company started enrollment for a Phase 2/3 randomized, placebo-controlled study to meticulously confirm whether remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19. The Phase 2/3 randomized controlled study of remestemcel-L would be conducted in 300 patients having COVID-19 induced ARDS (acute respiratory distress syndrome).
Moreover, the Company mentioned that more than 20 medical centers across the US would participate in this study which is projected to complete the enrollment within three to four months.
Shares of MSB climbed 6.329% to close at $3.360 on 30 April 2020.