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Clesrovimab (MK-1654):
Pediatric Clinical Program
Presentation to the Advisory Committee on Immunization Practices
Anushua Sinha, MD, MPH
Clinical Director -Vaccines Clinical Research
Merck & Co., Inc.
Rahway, NJ, USA
October 23, 2024
Confidential
Clesrovimab is a human monoclonal antibody with four unique molecular
characteristics that enable robust and durable protection from RSV
2Notes: a. Clesrovimab is ~50-fold more potent in vitro than palivizumab; Abbreviations : F=Fusion; RSV=Respiratory Syncytial Virus; Sources : 1. Tang A et al. Nat Commun . 2019; 2. RSV GeneBank sequences
as of April 1, 2024; 3. Phuah JY et al. Biomed Pharmacother. 2023.
ClesrovimabRSV Prefusion F protein
Site IVBinds with high affinity to site IV of RSV F protein,
prevents fusion of virus to host cells and blocks entry to
provide direct protection1
̶ Binding epitope on site IV is highly conserved , with 99.8% identity
among >15,000 reported RSV-A and RSV-B sequences2
High potency in vitro and equipotent against RSV-A and RSV-Ba
YTE substitutions enable extended half-life (~44 days)
4
Achieves high nasal tissue distribution and concentrations at sites
of RSV infection32
31
Site IV
Clesrovimab
Confidential
➢Prevention of respiratory syncytial virus (RSV) lower respiratory tract
disease in neonates and infants who are born during or entering their first
RSV seasonProposed Indication and Dosing
3Proposed Indication
➢105 mg/0.7 mL administered as a single intramuscular (IM) injection
➢Clesrovimab dosing is the same for all infants regardless of weightProposed Dosing and
Administration
Confidential
Clesrovimab Clinical Development Program
4
Phase 1:
Safety and PK – adults
Phase 1b/2a:
Safety and PK – infants
Phase 2b/3:
Efficacy, safety and PK –
infants & childrenPhase 1 – Adults
(Protocol 001)1
Completed
Phase 1b/2a – Infants (Protocol 002)3
Completed
2017 2018 2019 2020 2021 2022 2023Currently
here
Abbreviations: PK=Pharmacokinetics; RSV=Respiratory Syncytial Virus; Sources: 1. Aliprantis AO et al. Clin Pharmacol Drug Dev. 2021;10(5):556 -566; 2. Orito Y et al. Clin Transl Sci. 2022;15(7):1753 -1763;
3. Madhi SA, Simoes EAF, Acevedo A, et al. A phase 1b/2a single -ascending -dose study to evaluate the safety, tolerability, and pharmacokinetics of an RSV-neutralizing antibody, clesrovimab, in preterm
and full-term infants. Oral and Poster presentation. 8th ReSViNET Conference February 13-16, 2024 Mumbai, India; 4. clinicaltrials.gov (NCT04767373); 5. clinicaltrials.gov (NCT04938830).Phase 1 – Adults
(Protocol 003)2
CompletedPhase 1 – Adults, Infants
& Children (Protocol 008)
Completed
Phase 2b/3 – Infants (Protocol 004)4
Completed
Phase 3 – Infants & Children (Protocol 007)5
Ongoing
2024
Protocol 004:
A Phase 2b/3 Double -Blind, Randomized, Placebo -Controlled
Study to Evaluate the Efficacy and Safety of Clesrovimab in
Healthy Preterm and Full-Term Infants
Confidential
Protocol 004: Study Design
Phase 2b/3 randomized, double -blinded, placebo -controlled with active RSV surveillance through 6 months
Objective: Efficacy and safety of clesrovimab in healthy preterm and full-term infants entering their first RSV season
▪Phase 2b cohort : First 300 infants enrolled
▪Phase 3 cohort : Seamless enrollment following Phase 2b cohort
Experimental Arm
Comparator ArmRSV-Associated Efficacy
•MALRI ≥ 1 Indicator of LRI/Severity (primary)
•Hospitalization (secondary)
•Acute Respiratory Infection (ARI)b (tertiary)
•Lower Respiratory Infection Hospitalization
(tertiary)
•Severe MALRIc (tertiary)
•MALRI ≥ 2 Indicators of LRI/Severity (post -hoc)
Safety
•Adverse Events (AEs)
•Serious Adverse Events (SAEs)
Placebo
0.9% NaCl
(N = 1,203)
Clesrovimab
105 mg Single IM dose
(N = 2,411)
Randomization
2:1
(N = 3,614)aAll RSV-Associated
Efficacy Endpoints
followed through 6
months postdosedDay 1At Month 6 At Month 5
Notes : a. N=Number of randomized participants, dosed with clesrovimab or placebo ; b. ARI: Includes both upper and lower respiratory tract infection ; c. Severe MALRI : Severe hypoxemia (SpO 2 <90% on
room air at sea level; <87% on room air at altitude ≥1800 m) or the need for high flow nasal cannula, oxygen mask, or mechanical ventilatory support ; d. 6 month endpoints have the same designation as 5
month endpoints aside from Hospitalization through 6 months, which is a tertiary endpoint, and MALRI ≥ 1 indicator of LRI/Severity, which is a secondary endpoint ; Abbreviations : ARI=Acute Respiratory
Infection ; IM=Intramuscular ; LRI=Lower Respiratory Tract Infection ; MALRI=Medically -Attended Lower Respiratory Tract Infection ; NaCl=Sodium Chloride ; RSV=Respiratory Syncytial Virus .6First 1,650 infants
enrolled planned for
follow -up through
Day 515 postdose
(second RSV season)
Confidential
Protocol 004: Baseline Characteristics
7Clesrovimab
N = 2,411Placebo
N = 1,203
Participants n (%) n (%)
Age at Randomization (Months)
<6 1,923 (79.8) 964 (80.1)
≥6 to <9 383 (15.9) 192 (16.0)
≥9 105 (4.4) 47 (3.9)
Mean (SD) 3.7 (2.6) 3.7 (2.6)
Median (Range) 3.0 (0 to 12) 3.1 (0 to 12)
Body Weight at Randomization (kg)
Mean (SD) 5.8 (2.0) 5.9 (2.0)
Median (Range) 5.8 (1.6 to 11.9) 5.8 (1.6 to 11.6)
Gestational Age
Early and Moderate Preterm Infant (≥29 to <35 weeks) 422 (17.5) 209 (17.4)
Late Preterm and Full-term Infant (≥35 weeks) 1,989 (82.5) 994 (82.6)
Race
American Indian Or Alaska Native 50 (2.1) 18 (1.5)
Asian 641 (26.6) 320 (26.6)
Black Or African American 326 (13.5) 171 (14.2)
Multiple 302 (12.5) 138 (11.5)
Native Hawaiian Or Other Pacific Islander 1 (0.0) 1 (0.1)
White 1,082 (44.9) 550 (45.7)
Missinga 9 (0.4) 5 (0.4)
Ethnicity
Hispanic Or Latino 682 (28.3) 335 (27.8)
Not Hispanic Or Latino 1,660 (68.9) 834 (69.3)
Not Reported, Unknown, or Missing 69 (2.9) 34 (2.8)
Sex
Male 1,228 (50.9) 617 (51.3)
Female 1,183 (49.1) 586 (48.7)
Note: a. Includes 8 participants from South Africa who have race reported as "Colored" which is not a standard category on the form; Abbreviation: SD=Standard Deviation.•Baseline characteristics of
infants were similar in both
clesrovimab and placebo
arms
•A total of 3,614 healthy
infants were dosed
•2,411 infants received
clesrovimab and 1,203
infants received placebo
•Enrolled a diverse
population across race and
ethnicity from 22
countries, across 5
continents
•631 participants were
preterm infants (≥29 to
<35 weeks)
•2,983 were full-term
infants (≥35 weeks)
Confidential
RSV-Associated Endpointa
(Through 5 months)Endpoint
DesignationEfficacy through 5 months
Clesrovimab
(n = 2,398)Placebo
(n = 1,201)Observed Efficacy
%, (95% CI)
# of Cases # of Cases
Severe MALRI Tertiary 2 12 91.7 (62.9, 98.1)
LRI Hospitalization Tertiary 5 27 90.9 (76.2, 96.5)
Hospitalization Secondary 9 28 84.2d (66.6, 92.6)
MALRI requiring ≥ 2 Indicators of
LRI/Severityb Post -Hoc 10 41 88.0 (76.1, 94.0)
MALRI requiring ≥ 1 Indicator of
LRI/SeverityPrimary 60 74 60.4c (44.1, 71.9)
Acute Respiratory Infection (ARI) Tertiary 148 148 52.0 (39.5, 61.9)Protocol 004: Efficacy
Single dose of clesrovimab protects healthy preterm and full-term infants against mild, moderate, and severe RSV
disease through 5 months
8Notes: a. ARI and MALRI include both inpatient and outpatient cases; b. MALRI requiring ≥ 2 indicators of LRI/severity endpoint is most comparable to nirsevimab’s primary endpoint in the MELODY trial;
c. Primary endpoint, p<0.001 (criterion=lower bound of the 95% CI >25%); d. Secondary endpoint, p<0.001 (criterion=lower bound of the 95% CI >0%); Abbreviations: ARI=Acute Respiratory Infection;
LRI=Lower Respiratory Tract Infection; MALRI=Medically -Attended Lower Respiratory Tract Infection.Increasing Disease Severity
Confidential
RSV-Associated Endpointa
(Through 6 months )Endpoint
DesignationEfficacy through 6 months
Clesrovimab
(n = 2,398)Placebo
(n = 1,201)Observed Efficacy
%, (95% CI)
# of Cases # of Cases
Severe MALRI Tertiary 2 12 91.7 (62.9, 98.1)
LRI Hospitalization Tertiary 5 28 91.2 (77.2, 96.6)
Hospitalization Tertiary 11 29 81.3 (62.5, 90.7)
MALRI requiring ≥ 2 Indicators of
LRI/Severityb Post -Hoc 11 42 87.2 (75.1, 93.4)
MALRI requiring ≥ 1 Indicator of
LRI/SeveritySecondary 64 77 59.5 (43.3, 71.1)
Acute Respiratory Infection (ARI) Tertiary 161 154 50.0 (37.4, 60.1)Protocol 004: Efficacy
Durable across all endpoints through 6 months
9Notes: a. ARI and MALRI include both inpatient and outpatient cases; b. MALRI requiring ≥ 2 indicators of LRI/severity endpoint is most comparable to nirsevimab’s primary endpoint in the MELODY trial;
Abbreviations: ARI=Acute Respiratory Infection; LRI=Lower Respiratory Tract Infection; MALRI=Medically -Attended Lower Respiratory Tract Infection.Increasing Disease Severity
Confidential
Protocol 004: All-Cause Endpoints
10All-cause Endpoint
(Through 5 months
Postdose)Clesrovimab
(N = 2,411)Placebo
(N = 1,203)Observed Efficacy
(%) Estimate
(95% CI)c
nNumber
of EventsTotal Follow -
Up Time
(months)aIncidence
Rate Over 5
monthsb, %nNumber
of EventsTotal Follow -
Up Time
(months)aIncidence
Rate over 5
monthsb, %
Outpatient and
Inpatient MALRI
due to any cause2,398 526 10,349.2 25.4 1,201 296 5,063.8 29.213.1
(-0.6; 24.8)
LRI Hospitalization
due to any cause2,398 60 11,711.8 2.6 1,201 58 5,774.0 5.049.0
(26.7, 64.5)
Notes: a. One month is defined as 30 days for the total follow -up time calculation; b. Five months is defined as 150 days; c. Estimate and 95% CI of efficacy were estimated from the modified Poisson
regression with robust variance method; Every participant is counted a single time for each applicable endpoint category; A participant may appear in more than one endpoint category; For each
participant, only the first occurrence of the case for each endpoint category is counted for the analysis; N=Number of participants randomized and dosed with clesrovimab or placebo; n=Number of
participants eligible for inclusion in the full analysis set population; Abbreviations: CI=Confidence Interval; LRI=Lower Respiratory Tract Infection; MALRI=Medically -Attended Lower Respiratory
Tract Infection.
ConfidentialConfidential
Protocol 004: Safety
Well-tolerated in healthy preterm and full-term infants with a safety profile that is generally comparable to placebo
11Participants with AEsClesrovimab
Na = 2,409Placebo
Na = 1,202
n (%) n (%)
Overall Solicited and Unsolicited AEs (Days 1-365 postdose)
≥ 1 AE 1,816 (75.4) 918 (76.4)
Drug -related AE 587 (24.4) 296 (24.6)
Any SAE 278 (11.5) 149 (12.4)
Drug -related SAEb 1 (0.0) 1 (0.1)
Deathc 7 (0.3) 3 (0.2)
Solicited AEs (Days 1-5 postdose)
Injection site pain 122 (5.1) 77 (6.4)
Injection site erythema 90 (3.7) 40 (3.3)
Injection site swelling 65 (2.7) 31 (2.6)
Irritability 450 (18.7) 237 (19.7)
Somnolence 303 (12.6) 171 (14.2)
Decreased appetite 106 (4.4) 61 (5.1)
Solicited Temperature (Days 1 -5 postdose)
Temp < 100.4 °F 2,319 (96.3) 1,154 (96.0)
Temp ≥ 100.4 °F 89 (3.7) 48 (4.0)
AESI (Days 1 -42 postdose)
Rashd 11 (0.5) 4 (0.3)
Anaphylaxis/hypersensitivity 1 (0.0)e 0 (0.0)•Proportion of participants with AEs, including solicited AEs, drug-
related AEs, and SAEs, were generally comparable between
intervention groups; majority of AEs were Grade 1 or 2 toxicity
•Most (≥ 96%) participants in either intervention group had a
maximum temperature <100.4 °F
•There were no serious AESI of rash, anaphylaxis or hypersensitivity
observed in either intervention group
•Proportion of participants with AESI in the category of rash
(all non-serious) was low in either intervention group
•One participante experienced a non-serious AESI in the
category of anaphylaxis/hypersensitivity, which was a Grade
2 event of bronchospasm on Day 3 postdose in clesrovimab
group, not considered related to study intervention by
investigator
•No deaths were considered related to study intervention by
investigator; no pattern identified with respect to cause of death
or timing; largely attributable to underlying co-morbidities
Notes: a. N = number of participants randomized and dosed and included in the safety population; b. One infant had an SAE of body temperature increased in the clesrovimab group (with rectal temperature 38°C
on Day 4 and with adenovirus detected in stool on Day 8) and one infant had an SAE of B-cell lymphoma in the placebo group; c. One death occurred in the clesrovimab group on Day 487 after study discontinuation
(discontinued study based on physician’s recommendation); d. All AESI of rash were non-serious; All events were Grade 1 or 2 toxicity except for one Grade 3 event of urticaria on Day 9 postdose in clesrovimab
group, not considered related to study intervention by investigator. Abbreviations : AE=Adverse Event; AESI=Adverse Events of Special Interest; SAE=Serious Adverse Event.
Confidential
Protocol 004: Conclusions
12Efficacy
̶ Clesrovimab, administered as a single
dose for infants of all weights, provides
robust protection against mild,
moderate, and severe RSV disease for
all healthy infants, including term and
preterm
̶ Clinical data demonstrate over 90% efficacy
in preventing RSV LRI hospitalizations
through 6 months
̶ Clesrovimab efficacy is durable across
all efficacy endpoints through 6 months
̶ There was no shifting of RSV disease
burden seen in the second RSV season
Safety
̶ Clesrovimab is well tolerated in healthy
preterm and full-term infants born during or
entering their first RSV season, with a safety
profile that is generally comparable to placebo
Abbreviations: LRI=Lower Respiratory Tract Infection; MALRI=Medically -Attended Lower Respiratory Tract Infection; RSV=Respiratory Syncytial Virus.
Protocol 007:
A Phase 3, Multicenter, Randomized, Partially Blinded,
Palivizumab - Controlled Study to Evaluate the Safety, Efficacy,
and Pharmacokinetics of Clesrovimab in Infants and Children at
Increased Risk for Severe RSV Disease
Confidential
Protocol 007: Study Design
14•Safety / Tolerability – AEs up to day 42 and for 14 days after each
subsequent dose and SAEs for duration of study (primary)
•First RSV Season PK - Through 8 months
Palivizumab
3-5 doses IM
(N = 450)
Clesrovimab
105 mg IM dose [Day 1]
Placebo [Day 28]
(N = 446)
Randomization
1:1
(N = 896)aRSV-Associated Efficacy
•MALRIb ≥ 1 Indicator of
LRI/Severity (secondary)
•Hospitalization (secondary)
•Severe MALRI (tertiary /
exploratory)
•MALRI ≥ 2 Indicators of
LRI/Severity (post -hoc)Experimental Arm
Comparator ArmFirst RSV
Season
Second
RSV
Season(N = ~300)
Open -label
Clesrovimab
210 mg
To start 9 – 12 months
following participants’
first RSV season Dose 1
Notes: a. N=Number of randomized infants, dosed with clesrovimab or palivizumab; b. MALRI is defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more
of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample;
Abbreviations: AE=Adverse Event; IM=Intramuscular; MALRI=Medically -Attended Lower Respiratory Tract Infection; PK=Pharmacokinetics; RSV=Respiratory Syncytial Virus; SAE=Serious Adverse Event.Protocol 007 study is
ongoing and data
from the second RSV
season to be reported
in the futureRSV-Associated Efficacy
•MALRI ≥ 1 Indicator of
LRI/Severity (tertiary /
exploratory)
•Hospitalization (tertiary /
exploratory)
•MALRI ≥ 2 Indicators of
LRI/Severity (post -hoc)At Month 5 At Month 6
Phase 3, multicenter, randomized, partially blinded, palivizumab -controlled trial conducted with active surveillance over 2 RSV
seasons
Objective: Safety, pharmacokinetics and RSV-associated endpoint incidence rates of clesrovimab in infants &
children at increased risk for severe RSV disease
Confidential
Protocol 007: Baseline Characteristics
15Participant Characteristics `(`A`ll`D``o`sed Participants – First RSV Season) Clesrovimab
N = 446Palivizumab
N = 450
Participants in Population n (%) n (%)
Participants with Condition
CLD 124 (27.8) 126 (28.0)
CHD 52 (11.7) 49 (10.9)
Neither CLD nor CHD less than 29 weeks gestational agea 26 (5.8) 24 (5.3)
Neither CLD nor CHD greater than or equal to 29 weeks gestational agea 244 (54.7) 251 (55.8)
Age at Randomization (Months)
<6 409 (91.7) 390 (86.2)
≥6 to <9 33 (7.4) 51 (11.3)
≥9 4 (0.9) 9 (2.0)
Mean (SD) 3.0 (1.9) 3.0 (2.3)
Body Weight at Randomization (kg)
Mean (SD) 3.8 (1.5) 3.6 (1.5)
Median (Range)3.5
(1.1 to 9.6)3.2
(1.5 to 9.1)
Race
American Indian Or Alaska Native 5 (1.1) 7 (1.6)
Asian 82 (18.4) 80 (17.8)
Black Or African American 67 (15.0) 71 (15.8)
Multiple 56 (12.6) 53 (11.8)
Native Hawaiian Or Other Pacific Islander 5 (1.1) 2 (0.4)
White 231 (51.8) 237 (52.7)
Ethnicity
Hispanic Or Latino 138 (30.9) 146 (32.4)
Not Hispanic Or Latino 296 (66.4) 296 (65.8)
Not Reported or Unknown 12 (2.7) 8 (1.8)
Sex
Male 225 (50.4) 221 (49.1)
Female 221 (49.6) 229 (50.9)
Notes: a. Range of gestational age was 23 to 41 weeks; Abbreviations : AAP=American Academy of Pediatrics; CHD=Congenital Heart Disease; CLD=Chronic Lung Disease; GA=Gestational Age; RSV=Respiratory Syncytial Virus;
SD=Standard Deviation; Source: 1. Pediatrics. 2014 Aug 1;134(2):e620-38.•Baseline characteristics
were similar in both
clesrovimab and
palivizumab arms
•Enrolled diverse population
of different races and
ethnicities from 27
countries, across 6
continents
•In total, 401 of 896
(44.8%) participants met
the American Academy of
Pediatrics (AAP)
palivizumab eligibility
criteria (101 CHD; 250 CLD;
50 <29 weeks GA)1
Confidential
Protocol 007: Safety
Well-tolerated in infants at increased risk of severe RSV disease with a safety profile that is generally comparable to
palivizumab
16Participants with AEsClesrovimab
Na = 445Palivizumab
Na = 450
n (%) n (%)
Overall Solicited and Unsolicited AEs (following any dose, first RSV season)
≥ 1 AE 323 (72.6) 344 (76.4)
Drug -related AE 120 (27.0) 127 (28.2)
Any SAE 99 (22.2) 110 (24.4)
Drug -related SAE 0 (0.0) 2 (0.4)
Death 8 (1.8) 4 (0.9)
Solicited AEs (days 1 -5 postdose, first RSV season)
Injection site pain 26 (5.8) 32 (7.1)
Injection site erythema 29 (6.5) 20 (4.4)
Injection site swelling 26 (5.8) 12 (2.7)
Irritability 116 (26.1) 125 (27.8)
Somnolence 74 (16.6) 72 (16.0)
Decreased appetite 52 (11.7) 49 (10.9)
Solicited Temperature (days 1-5 postdose 1, first RSV season)
Temp < 100.4 °F 436 (98.0) 441 (98.0)
Temp ≥ 100.4 °F 9 (2.0) 9 (2.0)
AESI (days 1 -42 postdose 1, first RSV season)
Rash 3 (0.7) 1 (0.2)
Anaphylaxis/hypersensitivity 0 (0.0) 0 (0.0)•Proportion of participants with AEs, including solicited
AEs, drug -related AEs, and SAEs, were generally
comparable between intervention groups; majority of
AEs were Grade 1 or 2 toxicity
•Most (≥ 98%) participants in either intervention group
had a maximum temperature postdose 1 <100.4 °F
•No AESI of anaphylaxis/hypersensitivity were reported,
and the proportion of participants with AESI of rash
was low in either intervention group; all events were
non-serious and Grade 1 toxicity
•No deaths were considered related to study
intervention by investigator; no pattern identified with
respect to cause of death or timing; largely attributable
to underlying co-morbidities
Notes: a. N = Number of participants randomized and dosed and included in the safety population; Abbreviations: AE=Adverse Event; AESI=Adverse Event of Special Interest; SAE=Serious Adverse Event.
Confidential
Protocol 007: Incidence Rates
Comparable RSV disease incidence between clesrovimab and palivizumab groups
17RSV-Associated Endpointa
(Through 5 months Postdose)Clesrovimab
(N = 446)Palivizumab
(N = 450)
nNumber of
EventsIncidence Rate, %
(95% CI)d nNumber of
EventsIncidence Rate, %
(95% CI)d
MALRI Requiring ≥ 1
Indicator of LRI/Severityb 443 143.6
(2.0, 6.0)437 123.0
(1.6, 5.3)
Hospitalizationc 443 51.3
(0.4, 3.0)437 61.5
(0.6, 3.3)
Notes : a. MALRI includes both inpatient and outpatient cases; b. Defined as: RSV PCR positive and cough or difficulty breathing and at least 1 of the following: wheezing, chest wall indrawing/retractions,
rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; c. Respiratory Infection Hospitalization defined as: RSV PCR positive and hospital admission for respiratory illness; d.
Confidence intervals were estimated by exact Poisson confidence limits; N=number of participants randomized and dosed with clesrovimab or palivizumab; n=number of participants eligible for inclusion in
the full analysis set population; Abbreviations : CI=Confidence Interval; LRI=Lower Respiratory Tract Infection; MALRI=Medically -Attended Lower Respiratory Tract Infection.Note: Incidence rates in Protocol 007 are similar through 6 months postdose
Confidential
Protocol 007: PK Bridging
Supports extrapolation of efficacy to infants with increased risk of severe RSV with no dose-adjustment necessary
18•Non-inferiority trial in infants with increased risk of
severe RSV would be infeasible due to prohibitively
large sample size in already small population
•In agreement with regulators, PK bridging along
with evaluation of estimation of efficacy in Protocol
007 was deemed acceptable for assessment of
efficacy in this population
•PK exposures in infants with increased risk for severe
RSV are similar to those found in healthy infants ,
supporting extrapolation of efficacy to population
of preterm birth, CLD and/or CHD infants , without
requiring dose adjustmentsReference Group
Abbreviations : AUC=Area Under the Curve; CHD=Congenital Heart Disease; CLD=Chronic Lung Disease; PK=Pharmacokinetics; RSV=Respiratory Syncytial Virus.PK exposures in infants at increased risk of severe RSV
are similar to those in healthy infants
Confidential
Protocol 007: Conclusions
19Efficacy
̶ Efficacy in Protocol 007 population was
inferred by efficacy established from
Protocol 004, based on comparable
clesrovimab pharmacokinetic data
̶ In infants at increased risk for severe RSV
disease, a single dose of clesrovimab
protects against RSV disease , including RSV
hospitalization, through 6 months
Safety
̶ The safety profile of clesrovimab in infants at
increased risk of severe RSV disease is
generally comparable to palivizumab and
consistent with the safety profile in healthy
infants
Abbreviations : RSV=Respiratory Syncytial Virus.
Summary
Confidential
Clesrovimab Phase 2b/3 Study Conclusions
21Efficacy
Clesrovimab, administered as a single dose for
infants of any weight, provides robust protection
against mild, moderate, and severe RSV disease
for all infants, including term, preterm, and those
with risk factors
✓In healthy infants, clesrovimab is highly efficacious
against a broad spectrum of RSV disease endpoints,
with no shifting of RSV disease burden in second RSV
season (Protocol 004)
✓Over 90% efficacy in preventing RSV LRI
hospitalizations through 6 months
✓Clesrovimab also protects infants at increased risk
for severe RSV disease , comparable to palivizumab
(Protocol 007)
✓The dose is same for infants of all weights
✓Efficacy is sustained through 6 months, providing
durable efficacy for an entire typical RSV season
Safety
Clesrovimab is well-tolerated in infants, with a
safety profile that is generally comparable to
controls and consistent across infant
populations.
̶ Clesrovimab is well tolerated in healthy preterm
and full-term infants born during or entering their
first RSV season, with a safety profile that is
generally comparable to placebo
̶ The safety profile of clesrovimab in infants at
increased risk for severe RSV disease is generally
comparable to palivizumab and consistent with the
safety profile in healthy infants
Abbreviations : LRI=Lower Respiratory Tract Infection; MALRI=Medically -Attended Lower Respiratory Tract Infection; RSV=Respiratory Syncytial Virus.
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