- Several pharmaceutical companies have entered the race of developing a treatment to alleviate the severity of COVID-19 and improve mortality rates.
- On 15 June 2020, the FDA revoked emergency use authorisation (EUA) for hydroxychloroquine and chloroquine.
- Scotland based company TC BioPharm to study T-cell therapy for COVID-19 treatment in Edinburgh.
- Roche initiated Phase 3 trials of Actemra®/RoActemra® in combination with remdesivir in severe COVID-19 pneumonia patients who are hospitalised.
- Regeneron commenced the first clinical study of REGN-COV2 for prevention and treatment of the infectious disease.
- CytoDyn and NIH of Mexico signed an MOU to conduct a small Phase 3 trial for patients with severe COVID-19.
COVID-19 was first detected in December in Wuhan, China, and the infectious disease has spread at an alarming rate since then. The novel coronavirus has infected more than 10.53 million individuals and taken over 512,842 lives worldwide as reported to the WHO (as of 3:05 PM CEST on 2 July 2020).
Initially, the US FDA had announced two emergency-use authorisations (EUA) for COVID-19 treatments, including one for hydroxychloroquine sulfate and chloroquine phosphate in March and the other for remdesivir by Gilead Sciences Inc on 1 May 2020.
However, as per the recent update by the FDA, the agency revoked the emergency use authorisation for hydroxychloroquine and chloroquine on 15 June 2020. So far there is no approved drug or vaccine for COVID-19 as of 2 July 2020.
Presently, there is an urgent necessity to develop a vaccine or treatment for COVID-19, as the pandemic has impacted the global economy and the entire world is confronting greatest economic, financial as well as social shock.
While there are around 17 vaccines in clinical trials, according to the WHO, there are a significant number of drugs, including antivirals, in late-stage clinical studies. The reason is that most companies are evaluating already-approved drugs which helps them take the drug candidate directly into Phase 3 studies, thus saving considerable time. This is because the existing drugs have already been assessed for safety and tolerability in previous studies, eliminating the need to go through the initial stages again.
TC BioPharm to trial T cells Therapy COVID-19 treatment in Edinburgh
Scotland-based company TC BioPharm is engaged in developing safe and less expensive advanced allogeneic CAR-T cell therapy products to treat cancer, as well as developing gamma delta T-cell therapies for the treatment of several infections.
On 1 July 2020, TC BioPharm revealed that it is starting initial clinical trials at the Edinburgh Royal Infirmary. The Company also notified that it had submitted documents to UK regulators to start safety trials on an experimental therapy designed to kill COVID-19 infected cells. Regarded as the frontrunner in gamma-delta T-cell therapy, TC BioPharm (TCB) was the first Company for treating cancer patients using allogeneic GDT cell banks in an ICH-compliant clinical trial.
TCB has been in discussion with the UK regulatory body and has recently gained approval to treat hospitalised COVID-19 patients. Following this regulatory approval, the Company intends to begin clinical safety studies in the upcoming weeks.
Many scientific publications have reported that patients who are deficient in GDT cells are at the highest risk from COVID-19 and are not able to fight the infection. Recent data has demonstrated that patients with severe COVID-19 exhibit a deficiency of these virus-killing cells. Hence, it is anticipated that by donating these immune privileged cells banked from healthy volunteers, the immune system can fight with this infection.
Regeneron Commenced First Clinical Study of REGN-COV2
A leading biotechnology company Regeneron (NASDAQ:REGN), on 11 June, announced the commencement of the first clinical study of investigational antiviral antibody cocktail, REGN-COV2 for the prevention as well as treatment of COVID-19. The REGN-COV2 clinical program comprises four separate clinical study populations: two each for treatment and prevention:
- Hospitalised COVID-19 patients.
- Non-hospitalised symptomatic COVID-19 patients.
- Uninfected individuals in groups that are at high risk of exposure, like healthcare practitioners or first responders.
- Uninfected people with close exposure to COVID-19 patient, for instance, the patient's housemate.
The Company, on 2 July, announced that the Phase 3 US study of Kevzara® in COVID-19 patients failed to meet its endpoints and the trial was being stopped. However, the studies outside the US will continue and results are anticipated in Q3 2020.
Roche, partnership with Gilead, Commenced Phase 3 Clinical Trial of Actemra®/RoActemra® with Remdesivir in Severe COVID-19 Pneumonia Hospitalised Patients
On 28 May 2020, Roche disclosed that the Company is on the verge of completing the patient enrolment for a global, randomised, placebo-controlled, double-blinded Phase 3 clinical study of Actemra®/RoActemra® in COVID-19 patients who are hospitalised and have severe COVID-19 pneumonia. The Company anticipates the results of this trial in the summer. Roche is conducting this study in collaboration with Gilead Sciences Inc.
This Phase 3 trial is to assess the safety as well as the efficacy of Actemra®/RoActemra® plus the remdesivir (investigational antiviral drug), versus placebo plus remdesivir in severe COVID-19 pneumonia patients who are hospitalised. The trial aims to recruit ~450 patients worldwide.
CytoDyn and NIH of Mexico Complete MoU to Conduct Small Phase 3 Trial for Patients having Severe COVID-19
Late-stage biotechnology company CytoDyn is engaged in developing innovative therapies for numerous therapeutic indications based on a novel humanised monoclonal antibody named leronlimab that targets CCR5 receptor.
Recently, on 29 June 2020, the Company disclosed that it had entered into a Memorandum of Understanding (MOU) with the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) to conduct a COVID-19 Phase 3 clinical trial with leronlimab for severe as well as critically ill patients, with the likelihood of cooperating on further trials for COVID-19.
With this MOU CytoDyn will provide its leronlimab at its expense to the NIH and both groups will proceed forward expeditiously for completing the jointly agreed protocol to conduct this clinical trial. The Company highlighted that the study is in line with the US Phase 3 trial protocol.
With the escalating numbers of COVID-19 cases and without an approved treatment/vaccine until now, everyone is afraid and unsure of what lies ahead. However, as healthcare companies are burning their midnight oil to fasten the process of developing an effective treatment or a vaccine. The combined efforts of these organisations has provided some positive news regarding the development of a safe and effective treatment or a vaccine indicating that we might be getting closer to finding a solution to address one of the most severe pandemics the world has witnessed.