DUBLIN–(BUSINESS WIRE)–The “Disease Analysis: COVID-19 Treatment” report has been added to ResearchAndMarkets.com’s offering.
The commercial outlook for COVID-19 therapeutics is expected to decline progressively throughout 2021 due to the phased implementation of global vaccination programs, which should substantially reduce both outpatient and hospital COVID-19 cases.
Indeed, several vaccines being developed by Moderna, Pfizer/BioNTech, AstraZeneca, Novavax, and Johnson & Johnson have shown 66-95% effectiveness against symptomatic COVID-19 illness, and are also highly effective against COVID-19 hospitalization, though the potential emergence of new SARS-CoV-2 variants which may impair the effectiveness of vaccines against mild/moderate infections could partially revitalize the prospects for therapeutics aimed at the outpatient setting.
Veklury (remdesivir) is the first and only approved antiviral for the treatment of hospitalized COVID-19 patients in the US, and has been rapidly adopted as the global standard of care for moderate and severe patients since its initial US Emergency Use Authorization (EUA) in May 2020 (full approval occurred in October 2020).
Veklury’s rapid commercial success ($2.8bn in sales in 2020) has been driven by positive results from the US National Institutes of Health (NIH)-sponsored ACTT-1 study, which showed the drug significantly reduced the duration of hospitalization compared to placebo in patients with moderate-severe COVID-19 pneumonia.
While negative results from the World Health Organization’s (WHO’s) SOLIDARITY trial in October 2020 contradicted these initial findings, suggesting that Veklury does not significantly reduce the duration of hospitalization or the risk of mortality in hospitalized patients, and resulting in the WHO recommending against its use, demand nevertheless increased in Q4.
Indeed, in January 2021, Gilead noted that 50-60% of hospitalized US patients were being treated with remdesivir versus ~30% in October 2020, likely due to a lack of alternative options, thus the publisher expects the brunt of the impact of the WHO’s negative recommendation will only be felt once alternative agents become available for hospitalized patients.
Veklury faces myriad threats from pipeline candidates, including antivirals, immunomodulatory agents, monoclonal antibodies, and hyperimmune globulin therapies. Oral antivirals pose a particular threat, given that their similar mode of action means they are likely to produce comparable results in ongoing trials (or superior results if optimized for greater potency against the SARS-CoV-2 RNA polymerase), and their administration route would be more convenient than Veklury’s IV formulation.
Favipiravir is the nearest-term threat, with emergency approvals in India and Russia, and ongoing studies in the outpatient, hospital, and prophylaxis settings, though disappointing results from a study in hospitalized patients in Kuwait suggest favipiravir’s use will be limited to outpatients.
The overall likelihood of approval of a Phase I antiviral asset is 12.9%, and the average probability a drug advances from Phase III is 68.5%. Antiviral assets, on average, take 8.4 years from Phase I to approval, slightly shorter than the average of 9.0 years for all infectious disease assets. However, in the case of COVID-19, development periods have been shortened substantially to as little as 6-9 months as repurposed agents have been rushed through clinical trials and granted rapid reviews by regulators.
Pivotal trial data for a huge range of repurposed drugs are expected in H1 2021, including from Olumiant’s COV-BARRIER study evaluating the drug as a monotherapy against standard of care, and favipiravir’s PRESECO study evaluating its ability to prevent progression to severe infection in outpatients with mild-moderate infections.
Key Topics Covered:
OVERVIEW
- Latest key takeaways
DISEASE BACKGROUND
- Definition
- Transmission
- Symptoms
- Diagnosis
- Patient segmentation
- Risk factors
TREATMENT
- Therapies with full or conditional approvals (eg Emergency Use Authorization)
- Summary of US National Institutes of Health treatment guidelines
EPIDEMIOLOGY
- High-risk population prevalence methodology
- High-risk group prevalent populations
- High-risk group prevalent cases
- Infection fatality rate
- Hospitalization
- Hospitalized patient characteristics
MARKETED THERAPEUTIC AGENTS
PIPELINE THERAPEUTICS
KEY REGULATORY EVENTS
- Pandemic Perspectives: US FDA Wastes No Time In COVID-19 Emergency Use Authorization Reviews
- Dostarlimab, Zynteglo & COVID-19 Combo Drugs In The Spotlight At EMA
- COVID Therapeutics’ Progress (Or Lack Thereof) May Be Political Vulnerability For US FDA
- COVID Antibody Products May Get To Use Viral Load As Surrogate For Mutant-Targeted Versions
- Coronavirus Notebook: UK To Speed Up Trials Of New Drugs, Expands Use Of Tocilizumab
- Veklury Gets EMA All-Clear Over Kidney Problems, But Faces New Safety Review For Bradycardia
- US FDA Authorizes Lilly’s COVID-19 mAB Combo For Lower Doses Than Tested In Phase III
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Merck & Co. Will Manufacture J&J Vaccine, Other COVID-19 Medicines Under BARDA Deal
- Start-Up Scanwell Adds Another Collaboration, Targets Home COVID-19 Testing With BD
- Genexine, KGBio Ink $1.1bn License Pact
- Sensyne Partners With Excalibur To Improve Usability Of COVID-19 Tests
- US Supply Of OTC COVID-19 Tests Gets Boost Through $231.8M Contract For Australian Firm
- Lilly, Vir/GSK Team Up On COVID-19 Antibody Combination Regimen
- Thermo Fisher Scientific To Acquire Mesa Biotech
- AzurRx Licenses First Wave Bio’s Niclosamide Formulations
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
VEKLURY
FAVIPIRAVIR
OTHER ANTIVIRALS
- Other antiviral therapies to watch (no clinical data available)
IMMUNOMODULATORS
DEXAMETHASONE
ACTEMRA
OLUMIANT
- SNG001
LENZILUMAB
OTILIMAB
MK-7110
ZYESAMI
CERC-002
TRADIPITANT
LERONLIMAB
OTHER IMMUNOMODULATORY AGENTS
- Other immunomodulatory therapies to watch (limited or no clinical data available)
PROXALUTAMIDE
MONOCLONAL ANTIBODIES
- Other antibody therapies to watch (no clinical data available)
HYPERIMMUNE GLOBULINS
MARKET DYNAMICS
FUTURE TRENDS
RECENT EVENTS AND ANALYST OPINION
- Actemra for COVID-19 Treatment (March 10, 2021)
- ABX464 for COVID-19 Treatment (March 5, 2021)
- VIR-7831 for COVID-19 Treatment (March 3, 2021)
- CERC-002 for COVID-19 Treatment (March 2, 2021)
- Otilimab for COVID-19 Treatment (February 25, 2021)
- IMU-838 for COVID-19 Treatment (February 17, 2021)
- Aviptadil for COVID-19 Treatment (February 10, 2021)
- Multiple Drugs for COVID-19 Treatment (January 26, 2021)
- Ultomiris for COVID-19 Treatment (January 13, 2021)
- CERC-002 for COVID-19 Treatment (January 5, 2021)
KEY UPCOMING EVENTS
UNMET NEEDS
- Additional therapies capable of reducing time to recovery and/or mortality in hospitalized patients
- Convenient therapies capable of preventing progression to severe disease in outpatients
BIBLIOGRAPHY
APPENDIX
For more information about this report visit https://www.researchandmarkets.com/r/cephoq
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