Disease Analysis: COVID-19 Treatment
Publisher: Datamonitor Healthcare
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Definition
COVID-19 is an infectious disease caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus that emerged in late 2019 in Wuhan, China. As of October 2021, there have been 245,373,039 confirmed cases of COVID-19, and 4,979,421 deaths globally. SARS-CoV-2 belongs to the coronavirus family, which collectively cause respiratory and intestinal disease in
humans and animals, with other prominent members of the family including Middle East respiratory syndrome (MERS) virus and severe acute respiratory syndrome (SARS) virus.
Latest key takeaways
- Gilead’s 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 (SoC) 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 (sales totaled $5.6bn in 2021) has been driven by results of the ACTT-1 study, which showed that the drug significantly reduced the duration of hospitalization compared to placebo in patients with moderate-severe COVID-19 pneumonia. However, sales in 2022 have been on the decline, with Gilead’s Q2 financial results reporting a 46% decrease to $445m compared to the same period in 2021. The company has attributed this decline to changing COVID-19 infection rates and the severity of infections and hospitalizations, as well as the effectiveness of vaccination rollouts. During 2022, Veklury’s approval for use in COVID-19 treatment within the US has been expanded to also cover patients in the outpatient setting, for use in non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, while also covering the treatment of both hospitalized and non-hospitalized pediatric patients over 28 days old and weighing at least 3kg who are at high risk of progression to severe COVID-19. Previously, the World Health Organization (WHO) had recommended against Veklury’s use following disappointing results from the WHO-sponsored SOLIDARITY trial, which contradicted the positive findings in the ACTT-1 study; however, this recommendation has since been revised. As of April 2022, the WHO now recommends use of Veklury in mild or moderate COVID-19 patients who are at high risk of hospitalization. This change followed the release of results from Gilead’s Phase III PINETREE trial, which showed that a three-day course of Veklury treatment significantly reduced the risk of hospitalization for non-hospitalized patients at high risk of disease progression.
- Eli Lilly’s Olumiant (baricitinib) is an immunomodulatory therapy that has become the second COVID-19 treatment to achieve full US Food and Drug Administration (FDA) approval for the treatment of COVID-19, and is approved for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Dexamethasone is another immunomodulatory agent currently approved via emergency pathways in Japan, the EU, and UK for the treatment of severe and critical COVID-19 pneumonia patients, and is recommended in both WHO and US National Institutes of Health (NIH) treatment guidelines. Dexamethasone has the enviable status of being the only therapy shown to significantly reduce the risk of mortality in severe/critical patients, as Veklury failed to do so in the ACTT-1 study. Other key advantages that have aided rapid adoption of dexamethasone as part of the SoC include its flexibility of administration (oral, intramuscular, or intravenous) and its widespread generic availability, which could act as a substantial barrier to other branded immunomodulatory therapies seeking to displace it.
- Dexamethasone faces significant competition from pipeline products for severe COVID-19 patients, including repurposed immunomodulatory agents such as Roche’s Actemra (tocilizumab) and Eli Lilly’s Olumiant, as well as other new agents in development. Results for the IL-6R antagonist class have been largely negative, including those for Roche’s COVACTA and REMDACTA studies; however, the REMAP-CAP and RECOVERY studies have shown that Actemra can provide a modest reduction in mortality in severe and critical COVID-19 patients. Despite mixed results, the FDA has issued an EUA for the use of intravenous Actemra for the treatment of COVID-19 in hospitalized patients above two years of age who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation (invasive or non-invasive), or ECMO.
- Due to the evolution of the COVID-19 virus and its variants, authorizations for several monoclonal antibodies targeting the SARS-CoV-2 spike protein have been revoked by the FDA as a result of concerns over their effectiveness against the Omicron variant. These include Eli Lilly’s bamlanivimab ± etesevimab, Regeneron’s REGEN-COV, and GSK/Vir’s Xevudy (sotrovimab), all of which previously had been granted EUAs by the FDA. However, these recommendations have now been revoked since Omicron has become the dominant strain in the US.
- Convalescent plasma therapy is highly unlikely to confer any benefit in hospitalized patients following a string of negative readouts from randomized controlled trials (PLACID, REMAP-CAP, and RECOVERY) which showed that it provides no mortality benefit or reduced risk of progression to severe disease versus SoC alone. While the FDA’s revised EUA for convalescent plasma therapy still allows use in hospitalized patients earlier on in the course of the disease, it is surprising that the EUA has not been withdrawn altogether following the NIH’s decision in March 2021 to suspend a trial in mild-moderate hospitalized patients after a planned interim analysis showed that the therapy was unlikely to confer any benefit.
- The commercial outlook for COVID-19 therapeutics is expected to decline progressively due to the phased implementation of global vaccination programs, which should substantially reduce both outpatient and inpatient COVID-19 cases. Indeed, vaccination has been shown to provide 85% effectiveness against symptomatic COVID-19 illness and COVID-19 hospitalization, with breakthrough infections occurring in just 5% of vaccinated individuals. 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.
- The overall likelihood of approval of a Phase I antiviral asset is 11.8%, and the average probability a drug advances from Phase III is 63.3%. Antiviral assets, on average, take 8.5 years from Phase I to approval, slightly shorter than the average of 9.1 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.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
10 DISEASE BACKGROUND
10 Definition
10 Transmission
10 Symptoms
11 Diagnosis
11 Patient segmentation
12 Risk factors
14 TREATMENT
14 Therapies with full or conditional approvals (eg Emergency Use Authorization)
17 Summary of US National Institutes of Health treatment guidelines
19 EPIDEMIOLOGY
19 Vaccinations
19 Variants
19 High-risk group populations
20 High-risk group prevalent populations
22 MARKETED THERAPEUTIC AGENTS
28 PIPELINE THERAPEUTIC AGENTS
57 KEY REGULATORY EVENTS
57 Evusheld: UK Urged To Use RWD To Give Clinically Vulnerable Early Access To COVID-19 Treatment
57 AZ’s Evusheld Receives World-First Approval As COVID-19 Treatment, In Japan
58 Veru’s Sabizabulin Prioritized By European & US Regulators
58 Lilly Needs Updated FDA Authorization To Sell COVID Antibody On Commercial Market
60 PROBABILITY OF SUCCESS
61 LICENSING AND ASSET ACQUISITION DEALS
61 Shionogi and Medicines Patent Pool Partner To Bring COVID-19 Anti-Viral To 117 Countries
61 Merck Teams Up With Sinopharm To Commercialize Lagevrio In China
61 Good Works II Acquisition Corp. Signs An Agreement With Direct Biologics
61 Tetra Bio-Pharma Signs Agreement With Cellvera Global Holdings
62 New Consortium Pledges To Boost Supply Of COVID-19 Antivirals In LMICs
62 New €23m EU Research Consortium To Accelerate Repurposing
63 Hansoh In-Licenses 3CL Protease Inhibitor For COVID-19
63 Codexis Provides Enzymes For Pfizer’s Paxlovid Manufacturing
63 EMA Hails Success Of COVID-19 Multi-Regulator Collaboration
64 Coronavirus Update: Vir, WuXi Terminate COVID-19 Antibody Pact
64 NGOs Praise C-TAP COVID-19 Deals But Say Much More Needs To Be Done
64 AstraZeneca Buys Into COVID-19 Antibodies From Newly Launched RQ Bio
66 CLINICAL TRIAL LANDSCAPE
67 Sponsors by status
68 Sponsors by phase
69 Recent events
75 ANTIVIRALS
80 IMMUNOMODULATORS
87 Other immunomodulatory therapies (limited or no clinical data available)
89 MONOCLONAL ANTIBODIES
94 HYPERIMMUNE GLOBULINS
95 OTHER CLASSES
99 MARKET DYNAMICS
100 FUTURE TRENDS
100 Near-term versus long-term market changes
102 RECENT EVENTS AND ANALYST OPINION
102 Nangibotide for COVID-19 Treatment (October 25, 2022)
103 Sarconeos for COVID-19 Treatment (September 7, 2022)
105 Lenzilumab for COVID-19 Treatment (July 12, 2022)
106 LYT-100 for COVID-19 Treatment (June 14, 2022)
107 AT-527 for COVID-19 Treatment (May 10, 2022)
109 Paxlovid for COVID-19 Treatment (April 29, 2022)
111 Sabizabulin for COVID-19 Treatment (April 11, 2022)
112 Proxalutamide for COVID-19 Treatment (April 5, 2022)
114 ADG20 for COVID-19 Treatment (March 30, 2022)
115 RHB-107 for COVID-19 Treatment (March 1, 2022)
116 SNG001 for COVID-19 Treatment (February 21, 2022)
118 SAB-185 for COVID-19 Treatment (January 24, 2022)
120 MP0420 for COVID-19 Treatment (January 10, 2022)
121 Hocena for COVID-19 Treatment (January 07, 2022)
122 Mavrilimumab for COVID-19 Treatment (December 28, 2021)
123 PLX Cells for COVID-19 Treatment (December 27, 2021)
124 Rayaldee for COVID-19 Treatment (December 23, 2021)
126 Lagevrio for COVID-19 Treatment (December 16, 2021)
127 Arakoda for COVID-19 Treatment (December 15, 2021)
129 Paxlovid for COVID-19 Treatment (December 14, 2021)
130 MP0420 for COVID-19 Treatment (December 06, 2021)
131 Lagevrio for COVID-19 Treatment (November 30, 2021)
135 Zyesami for COVID-19 Treatment (November 29, 2021)
136 Lagevrio for COVID-19 Treatment (November 26, 2021)
138 OT-101 for COVID-19 Treatment (November 23, 2021)
140 Favipiravir for COVID-19 Treatment (November 12, 2021)
142 Xevudy for COVID-19 Treatment (November 12, 2021)
143 Brilacidin for COVID-19 Treatment (November 11, 2021)
144 Paxlovid for COVID-19 Treatment (November 5, 2021)
146 TQ Formula for COVID-19 Treatment (November 1, 2021)
149 KEY UPCOMING EVENTS
150 UNMET NEEDS
150 Additional therapies capable of reducing time to recovery and/or mortality in hospitalized patients
150 Convenient therapies capable of preventing progression to severe disease in outpatients
150 Long-haul COVID-19 patients
151 Market access
152 BIBLIOGRAPHY
158 APPENDIX
LIST OF FIGURES
28 Figure 1: Overview of pipeline drugs for COVID-19 treatment in the US
28 Figure 2: Pipeline drugs for COVID-19 treatment, by company
29 Figure 3: Pipeline drugs for COVID-19 treatment, by drug type
29 Figure 4: Pipeline drugs for COVID-19 treatment, by classification
60 Figure 5: Probability of success in the antiviral pipeline
66 Figure 6: Clinical trials in COVID-19 treatment and prevention
66 Figure 7: Top 10 drugs for clinical trials in COVID-19 treatment and prevention
67 Figure 8: Top 10 companies for clinical trials in COVID-19 treatment and prevention
67 Figure 9: Trial locations in COVID-19 treatment and prevention
68 Figure 10: COVID-19 treatment and prevention trials status
69 Figure 11: COVID-19 treatment and prevention trials sponsors, by phase
99 Figure 12: Market dynamics in COVID-19 treatment
100 Figure 13: Future trends in COVID-19 treatment
103 Figure 14: Nangibotide for COVID-19 Treatment (October 25, 2022): Phase II/III – ESSENTIAL (Europe)
105 Figure 15: Sarconeos for COVID-19 Treatment (September 7, 2022): Phase II/III – COVA
106 Figure 16: Lenzilumab for COVID-19 Treatment (July 12, 2022): Phase II/III – ACTIV-5/BET-B
109 Figure 17: AT-527 for COVID-19 Treatment (May 10, 2022): Phase III – MORNINGSKY (Mild or Moderate)
112 Figure 18: Sabizabulin for COVID-19 Treatment (April 11, 2022): Phase III – Hospitalized Patients
114 Figure 19: Proxalutamide for COVID-19 Treatment (April 5, 2022): Phase III – MRCT
118 Figure 20: SNG001 for COVID-19 Treatment (February 21, 2022): Phase III – SPRINTER
124 Figure 21: PLX Cells for COVID-19 Treatment (December 27, 2021): Phase II – (Europe/Israel), Phase II – PLX-COV-01 (Severe)
140 Figure 22: OT-101 for COVID-19 Treatment (November 23, 2021): Phase II – Hospitalized Patients
143 Figure 23: Xevudy for COVID-19 Treatment (November 12, 2021): Phase III – COMET-TAIL (Early Treatment)
146 Figure 24: Paxlovid for COVID-19 Treatment (November 5, 2021): Phase II/III – EPIC-HR (Nonhospitalized Symptomatic)
148 Figure 25: TQ Formula for COVID-19 Treatment (November 1, 2021): Phase II – BOSS
149 Figure 26: Key upcoming events in COVID-19 treatment (1 of 2)
149 Figure 27: Key upcoming events in COVID-19 treatment (2 of 2)
LIST OF TABLES
12 Table 1: Clinical status scores and interpretations
20 Table 2: High-risk populations and prevalence sources
21 Table 3: Estimated prevalent population in each COVID-19 high-risk group, by region
23 Table 4: Marketed therapeutic agents for COVID-19
30 Table 5: Pipeline therapeutic agents for COVID-19 in the US
102 Table 6: Nangibotide for COVID-19 Treatment (October 25, 2022)
104 Table 7: Sarconeos for COVID-19 Treatment (September 7, 2022)
105 Table 8: Lenzilumab for COVID-19 Treatment (July 12, 2022)
107 Table 9: LYT-100 for COVID-19 Treatment (June 14, 2022)
108 Table 10: AT-527 for COVID-19 Treatment (May 10, 2022)
110 Table 11: Paxlovid for COVID-19 Treatment (April 29, 2022)
111 Table 12: Sabizabulin for COVID-19 Treatment (April 11, 2022)
113 Table 13: Proxalutamide for COVID-19 Treatment (April 5, 2022)
114 Table 14: ADG20 for COVID-19 Treatment (March 30, 2022)
116 Table 15: RHB-107 for COVID-19 Treatment (March 1, 2022)
117 Table 16: SNG001 for COVID-19 Treatment (February 21, 2022)
119 Table 17: SAB-185 for COVID-19 Treatment (January 24, 2022)
120 Table 18: MP0420 for COVID-19 Treatment (January 10, 2022)
121 Table 19: Hocena for COVID-19 Treatment (January 07, 2022)
122 Table 20: Mavrilimumab for COVID-19 Treatment (December 28, 2021)
123 Table 21: PLX Cells for COVID-19 Treatment (December 27, 2021)
125 Table 22: Rayaldee for COVID-19 Treatment (December 23, 2021)
126 Table 23: Lagevrio for COVID-19 Treatment (December 16, 2021)
128 Table 24: Arakoda for COVID-19 Treatment (December 15, 2021)
129 Table 25: Paxlovid for COVID-19 Treatment (December 14, 2021)
130 Table 26: MP0420 for COVID-19 Treatment (December 06, 2021)
132 Table 27: Lagevrio for COVID-19 Treatment (November 30, 2021)
135 Table 28: Zyesami for COVID-19 Treatment (November 29, 2021)
137 Table 29: Lagevrio for COVID-19 Treatment (November 26, 2021)
139 Table 30: OT-101 for COVID-19 Treatment (November 23, 2021)
141 Table 31: Favipiravir for COVID-19 Treatment (November 12, 2021)
142 Table 32: Xevudy for COVID-19 Treatment (November 12, 2021)
143 Table 33: Brilacidin for COVID-19 Treatment (November 11, 2021)
145 Table 34: Paxlovid for COVID-19 Treatment (November 5, 2021)
147 Table 35: TQ Formula for COVID-19 Treatment (November 1, 2021)
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