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How soon we will have an answer to COVID-19?

Coronavirus (COVID-19) has affected more than ~2.0Mn people worldwide and killed at least 134,733. (As of 16th April 2020). As the number of COVID-19 confirmed cases continue to surge, healthcare workers have started coming up with medical treatments which could counter the worldwide spread of the disease.

Currently, the U.S. Food and Drug Administration has not approved any medication which could combat COVID-19. However, the U.S. FDA initiated a Coronavirus Treatment Acceleration Program (CTAP) to help expedite the regulatory process for COVID-19 for quick availability of effective therapies in the market.

There are more than 479 trials listed on clinicaltrials.gov, out of which approximately 218 studies are interventional testing drugs and combination products. However, given the rapid-spread nature of the disease, many companies are rapidly initiating trials and the number of ongoing trials may vary.

Figure1: Depicts the total number of ongoing clinical studies in coronavirus disease in all the phases. (As of 13th April 2020)

Although, most of the people infected with COVID-19 only experience minor symptoms, the disease can cause severe respiratory issues in some immunocompromised cases – even resulting in death. Moreover, the virus can easily spread from direct contact and affects people of all age groups.

Majority of the therapy options are divided into two distinct mechanism of actions-

  • Directed at resolving respiratory issues, including inflammation associated with severe cases
  • Targeting antiviral growth with an aim to stop multiplication of viruses in the body

Treatments

A wide number of pharmaceutical and healthcare companies have stepped forward to develop efficient treatments which could kill the SARS-CoV-2 virus. Universities and institutes are also conducting trials and testing therapies for COVID-19.

The table below highlights favorable treatment options in development for COVID-19:

Table 1: Treatments in development for COVID-19. The table focuses on industry-sponsored drugs and captures unique molecules (irrespective of geographies and investigators) for non-industry sponsored therapies

 Vaccines

Vaccine development is done in phases and generally takes longer and involves more people every passing phase. However, due to current situation of pandemic, vaccine could arrive to the people as early as possible.

Moreover, corona viruses were already being tested by researchers earlier, the learning of which could help the healthcare researchers to conduct faster trials in COVID-19.

Table 2: Vaccines in development for COVID-19

Moderna therapeutics is developing a promising approach on a COVID-19 vaccine called the mRNA-1273. This vaccine was tested straight in Phase 1 human trials before being tested preclinically on animals. Moderna therapeutics has estimated that the vaccines can be made available by the fall of 2020 for healthcare workers who are continuously exposed to high risk.

It is assumed that the ChAdOx1 vaccine by University of Oxford would start its manufacturing by September this year, however according to the CMO, England its highly unlikely that the benefits of the vaccine could be utilized by this year.

According to the WHO, there are more than 60 vaccines in preclinical trial development. Some of the industry sponsored vaccines in preclinical stage include-

Table 3: Vaccines in preclinical stage for COVID-19.

Estimation of Drug Approval

As the virus is spreading at an increased rate, there is an urgent need for the early development of treatments. Ideally, drug development process can take multiple years for completion combined with trial failures.

Here is a look at what is available and how soon the vaccines/treatments could be ready.

Please note that some of these timelines could shift, and some of these treatments and vaccines are likely to fail which can cause a shift in the approval estimates.

Figure 2: Estimated approval timeline for COVID-19 therapies in the U.S.

 

Remdesivir (Gilead Sciences)

Gilead Sciences on April 10, 2020 announced results from a compassionate use study. The cohort under study included 53 patients treated with remdesivir. Remdesivir caused an improvement in 68 percent (36/53) of patients who were on oxygen support.

However, Gilead sciences need to generate sufficient data of Remdesivir to secure U.S.FDA approval. Gilead conducted two Phase 3 trials in China among moderate and severe Covid-19 patients, which were terminated due to low patient enrollment. According to business standard report, the drug did not demonstrate improvement in patients in the Chinese trial. The company will be conducting further Phase 3 studies of Remdesivir to support the results from the compassionate use study. Data from the trials assessing severe symptom patients will be released by April end, and from the trials assessing moderate symptom patients will be released in May.

Taking 1 month for NDA submission and U.S. FDA review under the CTAP program. Given the trial results are positive, expected approval would be in June 2020.

Favipiravir/Avigan (Fujifilm Toyama)

The U.S. FDA approved a Phase 3 randomized trial of Favipiravir that could be used to treat COVID-19 patients in the U.S. The company mentions the estimated enrollment in the trial to be around ~50 to 60 patients, focused across 3 sites in U.S. Assuming the trial would take ~ 3 months for completion including data read-out i.e. July 2020. Taking 1 month for NDA submission and U.S. FDA review under the CTAP program, estimated approval would be in July end/ early Aug 2020. (Given positive trial results)

Tocilizumab/Actemra (Roche)

The Chinese authority have approved Tocilizumab drug usage for patients showing severe symptoms of COVID-19. However, approval from China’s National Medical Product Administration to sell Tocilizumab in COVID-19 patients is still pending. Roche will be conducting a Phase III clinical trial of Actemra in adults with severe Covid-19 pneumonia (COVACTA trial). Two Scenarios can be considered for the estimated approval of Tocilizumab.

  • High Case– The Primary completion date of the trial is August 2021. Roche confirms that the results could be shared as early as possible. (assuming Roche takes 3 months for data release i.e. July 2020). Taking 1 month for BLA submission and U.S. FDA review, given positive trial results, approval is expected by end of Aug 2020.
  • Base Case- Given the Phase 3 study will be initiated in April 2020 and has primary completion date (PCD) of August 2021. Assuming Roche would take 1 month for release of data after its PCD. Taking 1 month for BLA submission and U.S. FDA review, estimated approval would be in Oct 2021.

CD24Fc (Onco Immune)

Oncoimmune initiated a Phase 3 trial in April 2020 with Primary completion date in May 2021. Assuming the full results to be declared in June 2021. Taking 1-month for NDA submission and U.S. FDA review under the CTAP program, estimated approval will be July 2021.

 Tradipitant (Vanda Pharma)

Vanda Pharmaceuticals initiated Phase 3 clinical study (ODYSSEY VLY-686-3501) in hospitalized patients with COVID-19. The expected primary completion date of the study is August 2020. Assuming Vanda pharma would take one month for data readout. Taking 1 month for NDA submission and U.S. FDA data review, if the results are positive, estimated approval would be in Oct 2020.

Convalescent plasma

According to an article published by stat news, convalescent plasma can be beneficial, but research could take months before it is made available as a procedure to the public.

A trial conducted in China testing convalescent plasma therapy on 10 patients demonstrated favorable results. Seven out of ten people showed decreased viral loads and improvements in other condition.

Takeda is also testing a different form of convalescent plasm therapy where more concentrated antibodies are used. Takeda estimates the therapy will be made available in approx. nine to 18 months.

Vaccines

Vaccines take longer to develop as it passes through various phases before being available to the public. mRNA approach being developed by various companies helps in making proteins that can boost immunity. Moderna Therapeutics is applying the same approach including BioNTech and Pfizer, for the development of vaccine.

It can take approximately 18 months or more for development of effective vaccines for COVID-19. Even after the vaccines are approved, supply issues would rise due to the increased demand. Other approaches are also being developed on which various companies including Sanofi, Medicago, Zydus and Inovio are working.

Moreover, Moderna had announced that the vaccine would not be available for at least 12-18 months, however, it might be available for some groups by fall 2020, under emergency use.

 Conclusion

Data collection from clinical trials involves considerable time and efforts, so there is likely chance of absence of specific data until next few months or later.

The greater number of trials being conducted would give researcher more data to arrive at conclusions and more valuable the information would be.

If the trial results turn out to be favorable, we could expect first U.S. FDA approval of the drug Remdesivir by early June 2020, followed by Fujifilm Toyama’s favipiravir by July end or early August this year.

It can take atleast 18 months for a vaccine to develop and be available in the market for COVID-19. Moreover, Moderna could give a sigh of relief to the healthcare workers if its estimates of launching an mRNA vaccine by fall of 2020 proves true.

 Sources:

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