Delving into the Latest Updates on Rilematovir with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

JNJ-53718678, JNJ-678, JNJ-8678

Target

RSV F protein

Action

inhibitors

Mechanism

Respiratory syncytial virus F protein inhibitors

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Acute lower respiratory tract infectionAcute respiratory infectionsAcute upper respiratory infection+ [3]

Originator Organization

Johnson & Johnson

Active Organization-

Inactive Organization

Johnson & Johnson (China) Investment Ltd.Janssen Research & Development LLCJanssen Sciences Ireland Unlimited Co.

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

RegulationBreakthrough Therapy (China)

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Structure/Sequence

Molecular FormulaC21H20ClF3N4O3S

InChIKeyGTQTUABHRCWVLL-UHFFFAOYSA-N

CAS Registry1383450-81-4

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)

The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).

Start Date06 Sep 2021

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Rilematovir

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100 Translational Medicine associated with Rilematovir

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100 Patents (Medical) associated with Rilematovir

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16

Literatures (Medical) associated with Rilematovir

01 Sep 2024·REVIEWS IN MEDICAL VIROLOGY

Systematic Review of the Efficacy and Safety of RSV‐Specific Monoclonal Antibodies and Antivirals in Development

Review

Author: Adam W. Bartlett ; Siobhan Hurley ; Andrea T. K. Sevendal ; William Rawlinson ; Gregory J. Walker

ABSTRACT:

Respiratory syncytial virus (RSV) is a leading cause of acute respiratory infection amongst all ages, causing a significant global health burden. Preventative and therapeutic options for RSV infection have long been under development, and recently, several widely‐publicised vaccines targeting older adult and maternal populations have become available. Promising monoclonal antibody (mAb) and antiviral (AV) therapies are also progressing in clinical trials, with the prophylactic mAb nirsevimab recently approved for clinical use in infant populations. A systematic review on current progress in this area is lacking. We performed a systematic literature search (PubMed, Embase, Web of Science, ClinicalTrials.gov, EudraCT, ANZCTR—searched Nov 29th, 2023) to identify studies on all RSV‐specific mAbs and AV therapies that has undergone human clinical trials since year 2000. Data extraction focused on outcomes related to the therapeutic efficacy and safety of the intervention on trial, and all studies were graded against the OCEBM Levels of Evidence Table. Results from 59 studies were extracted, covering efficacy and safety data on six mAbs (motavizumab, motavizumab‐YTE, nirsevimab, ALX‐0171, suptavumab, clesrovimab) and 12 AV therapies (ALN‐RSV01, RSV604, presatovir, MDT‐637, lumicitabine, IFN‐α1b, rilematovir, enzaplatovir, AK0529, sisunatovir, PC786, EDP‐938). Of the mAbs reviewed, nirsevimab and clesrovimab hold considerable promise. The timeline for RSV‐specific AV availability is less advanced, although EDP‐938 and AK0529 have reported promising phase 2 efficacy and safety data. Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development.

Trial Registration:

PROSPERO registration: CRD42022376633

31 Dec 2020·Clinical infectious diseases : an official publication of the Infectious Diseases Society of AmericaQ1 · MEDICINE

Clinical Development of Respiratory Syncytial Virus Antivirals—What We Can Learn From Oseltamivir

Q1 · MEDICINE

Article

Author: Bont, Louis J ; Löwensteyn, Yvette N

Respiratory syncytial virus (RSV) is a major cause of morbidity and mortality among specific risk groups, including infants with or without comorbidities, older adults, and immunocompromised patients.Severe RSV disease in preterm infants and children with congenital heart disease can be prevented by palivizumab, a monoclonal antibody against the fusion (F) protein of RSV.Respiratory syncytial virus antiviral agents that are currently being developed can be divided into diferent therapeutic classes: antibodies, fusion inhibitors, and nucleoside analogs.The major success of oseltamivir, a neuraminidase inhibitor, as treatment for influenza followed a human-challenge trial showing antiviral and clin. effect of early treatment and subsequent real-life efficacy in adults who were treated within 36 h afer the onset of influenza-like illness.In children, the duration of illness was reduced by 1.5 days compared with placebo when given within 48 h of onset of illness.The author successfully demonstrated that early initiation of oseltamivir significantly shortened the duration of influenza A illness with 3.5 days and reduced parental absence from work.

17 Dec 2020·Clinical infectious diseases : an official publication of the Infectious Diseases Society of AmericaQ1 · MEDICINE

Pharmacokinetics, Safety, and Antiviral Effects of Multiple Doses of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678, in Infants Hospitalized With RSV Infection: A Randomized Phase 1b Study

Q1 · MEDICINE

Article

Author: Stevens, Marita ; Rojo, Pablo ; Rusch, Sarah ; Huntjens, Dymphy ; Epalza, Cristina ; Remmerie, Bart ; Vingerhoets, Johan ; McFadyen, Katie ; Martinón-Torres, Federico ; Baraldi, Eugenio ; Ferrero, Fernando

Abstract:

Background:

This phase 1b study evaluated the pharmacokinetics, safety, and antiviral effects of the respiratory syncytial virus (RSV)–specific fusion inhibitor JNJ-53718678 (JNJ-8678) in hospitalized RSV-infected patients aged > 1 to ≤24 months.

Methods:

Patients categorized by age (cohort 1: ≥6 to ≤24 months; cohort 2: ≥3 to < 6 months; cohort 3: > 1 to < 3 months) were randomized to oral JNJ-8678 or placebo once daily for 7 days. Dose increases followed data review committee recommendations (cohort 1: 2/6/8/9 mg/kg; cohort 2: 1.5/4.5/6 mg/kg; cohort 3: 1/3/5 mg/kg). Cohort 1 included a 9 mg/kg dose, as target exposures were not reached at lower doses. Sparse pharmacokinetic samples were assessed using population pharmacokinetics modeling. Safety was assessed by adverse events (AEs), laboratory tests, and electrocardiograms. To assess antiviral effects, RSV RNA viral load from nasal swabs was quantified over time using reverse-transcription quantitative polymerase chain reaction.

Results:

Patients received JNJ-8678 (n = 37) or placebo (n = 7). Pharmacokinetic parameters were similar at the highest doses for cohorts 1–3 (area under the plasma concentration–time curve from time of administration up to 24 hours postdosing at day 7: 35 840, 34 980, and 39 627 ng × hour/mL, respectively). Two grade 3 AEs were reported (both bronchiolitis; 1 JNJ-8678, 1 placebo), reported as serious AEs; all other AEs were grade 1 or 2. Two additional serious AEs were reported (rhinitis [JNJ-8678]; pneumonia [placebo]). No deaths, grade 4 AEs, or AEs leading to discontinuation were reported. Median RSV viral load change from baseline in JNJ-8678 vs placebo by day 3 was −1.98 vs −0.32 log10 copies/mL.

Conclusions:

In RSV-infected infants, JNJ-8678 was well tolerated. Target exposures were reached and antiviral activity was observed.

Clinical Trials Registration:

NCT02593851.

100 Deals associated with Rilematovir

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute lower respiratory tract infection	Phase 3	United States	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	China	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	Japan	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	Argentina	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	Belgium	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	Brazil	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	Bulgaria	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	Czechia	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	Estonia	Janssen Research & Development LLC	06 Sep 2021
Acute lower respiratory tract infection	Phase 3	Germany	Janssen Research & Development LLC	06 Sep 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03656510 (CTgov)	Phase 2	Acute lower respiratory tract infection \| Respiratory Syncytial Virus Infections	246	placebo+JNJ-53718678 (Cohorts 1 and 2: Placebo)	ecvouydapz(bmarxseehp) = agiqiojzef mntmverhms (vnobiryewz, ejhtdmmtfr - mzwumixekd) View more	-	21 Sep 2023
				JNJ-53718678 (Cohorts 1 and 2: JNJ-53718678 Low Dose)	ecvouydapz(bmarxseehp) = uyeerdelll mntmverhms (vnobiryewz, wrmupeojwj - mabdugcrpj) View more
NCT03379675 (Pubmed)	Phase 2	Respiratory Syncytial Virus Infections	72	Rilematovir 500 mg	hcniomabyg(mcnwvaqjnf) = lfxeqystfm pksigvjmzq (ixukbpyniq, -0.837 to 1.011) View more	-	06 Jul 2023
				Rilematovir 80 mg	hcniomabyg(mcnwvaqjnf) = psmkxihjrc pksigvjmzq (ixukbpyniq, -2.171 to 1.963) View more
NCT04978337 (PRIMROSE, CTgov)	Phase 2	Pneumonia due to respiratory syncytial virus	5	placebo+rilematovir (Placebo)	ccqkbynddh = qgdxrnfjqv rnpaaydkrl (txztuicegq, cxrpmqkaav - jfjvcrzyyo) View more	-	21 Apr 2023
				Rilematovir (Rilematovir 250 mg Bid)	ufeazmpgym = gcttbrdflg ycjtqdinya (nsdfjboboq, xcrwkadxkn - hcrksbzalx) View more
NCT04056611 (FREESIA, CTgov)	Phase 2	Respiratory Syncytial Virus Infections	3	rilematovir	tagnjyutjq = qpxejhmqnx lcfxfpgyox (aswyfbbgcz, afapiqlnvv - yzcahuayid) View more	-	14 Apr 2023
NCT04583280 (DAISY, CTgov)	Phase 3	Acute lower respiratory tract infection \| Respiratory Syncytial Virus Infections	28	Placebo (Placebo)	kkxwgpughc = osnhaiqank bgdtdabopt (usyhjlntkr, toknzhinsl - zkxxvywdbb) View more	-	10 Apr 2023
				Rilematovir (Rilematovir)	kkxwgpughc = ncogmkarpx bgdtdabopt (usyhjlntkr, yyigkddajc - eoisbvilgg) View more
NCT03379675 (CTgov)	Phase 2	Respiratory Syncytial Virus Infections	72	JNJ-53718678 500 mg (Treatment A: JNJ-53718678 500 mg)	fellbjznag(fjwwinvgah) = ppipcmuvls dhzlrlbtmz (xjeardkrti, 89.55) View more	-	28 Jun 2022
				Placebo+JNJ-53718678 80 mg (Treatment B: JNJ-53718678 80 mg + Placebo)	fellbjznag(fjwwinvgah) = dtxjnxspqw dhzlrlbtmz (xjeardkrti, 67.39) View more
NCT04068792 (CTgov)	Phase 2	Acute upper respiratory infection \| Acute lower respiratory tract infection \| Respiratory Syncytial Virus Infections	22	placebo+JNJ-53718678 (Placebo)	whkgyrqeok(obydkrixjh) = zhqjuqxfje avwphvpcrp (veitnciklp, cokquumqdo - gghbclwrif) View more	-	08 Jun 2022
				JNJ-53718678 (JNJ-53718678)	whkgyrqeok(obydkrixjh) = ummxymyzjw avwphvpcrp (veitnciklp, rsnzzkvcuz - fshtwizfrg) View more
EUCTR2014-005041-41-GB \| NCT02387606 (Pubmed \| Am J Trop Med Hyg \| J Infect Dis) Manual	Phase 2	Respiratory Syncytial Virus Infections	69	JNJ-53718678	jlxvhjobcr(wtvznfnbpl) = fsjcftmvej oxqolejbdh (zrzjmtnkll ) View more	Positive	24 Jul 2018
				Placebo	jlxvhjobcr(wtvznfnbpl) = uzxzarlehn oxqolejbdh (zrzjmtnkll ) View more