A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus

The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

Start Date05 Nov 2018

Sponsor / Collaborator

Janssen Research & Development LLC

JPRN-jRCT2080223955

/ Unknown statusPhase 2

Start Date25 Jun 2018

Sponsor / Collaborator

Janssen Pharmaceuticals, Inc.

NCT03468777

/ TerminatedPhase 1

A Phase 1, Open-label, Randomized, Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Subjects

The main purpose of study is to evaluate the effect of multiple-dose administration of lansoprazole (and optional: time-separated single dose administration of ranitidine) on the pharmacokinetics (PK) of JNJ-63549109 after a single dose of lumicitabine in healthy adult participants, under fasted (and optional: fed) conditions.

Start Date06 Mar 2018

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Lumicitabine

100 Translational Medicine associated with Lumicitabine

100 Patents (Medical) associated with Lumicitabine

Literatures (Medical) associated with Lumicitabine

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

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

08 Aug 2024·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of GS-7682, a Novel 4′-Cyano-Modified C-Nucleoside Prodrug with Broad Activity against Pneumo- and Picornaviruses and Efficacy in RSV-Infected African Green Monkeys

Article

Author: Ellis, Scott ; Bilello, John P ; Zhao, Xiaofeng ; Cihlar, Tomas ; Clarke, Michael O ; Pitts, Jared ; Marchand, Bruno ; Chun, Kwon ; Barauskas, Ona ; Murakami, Eisuke ; Rautiola, Davin ; Wang, Ting ; Irshad, Hammad ; Subramanian, Raju ; Goyal, Bindu ; Feng, Joy Y ; Vermillion, Meghan S ; Ma, Bin ; Xu, Yili ; Stray, Kirsten ; Nayak, Arabinda ; Palmiotti, Chris ; Mackman, Richard L ; Kuehl, Philip J ; Hui, Hon C ; Ishida, Kazuya ; Perry, Jason K ; Chin, Gregory ; Lee, Gary ; Zhang, Lijun ; Keeney, Michael ; Kadrichu, Nani ; Perron, Michel ; Siegel, Dustin S ; Riola, Nicholas C ; Doerffler, Edward ; Yang, Hai ; Vijjapurapu, Arya ; Seung, Minji ; Tomkinson, Adrian

Acute respiratory viral infections, such as pneumovirus and respiratory picornavirus infections, exacerbate disease in COPD and asthma patients. A research program targeting respiratory syncytial virus (RSV) led to the discovery of GS-7682 (1), a novel phosphoramidate prodrug of a 4'-CN-4-aza-7,9-dideazaadenosine C-nucleoside GS-646089 (2) with broad antiviral activity against RSV (EC₅₀ = 3-46 nM), human metapneumovirus (EC₅₀ = 210 nM), human rhinovirus (EC₅₀ = 54-61 nM), and enterovirus (EC₅₀ = 83-90 nM). Prodrug optimization for cellular potency and lung cell metabolism identified 5'-methyl [(S)-hydroxy(phenoxy)phosphoryl]-l-alaninate in combination with 2',3'-diisobutyrate promoieties as being optimal for high levels of intracellular triphosphate formation in vitro and in vivo. 1 demonstrated significant reductions of viral loads in the lower respiratory tract of RSV-infected African green monkeys when administered once daily via intratracheal nebulized aerosol. Together, these findings support additional evaluation of 1 and its analogues as potential therapeutics for pneumo- and picornaviruses.

21 Dec 2023·Journal of biomolecular structure & dynamics

Dynamics and binding affinity of nucleoside and non-nucleoside inhibitors with RdRp of SARS-CoV-2: a molecular screening, docking, and molecular dynamics simulation study

Article

Author: Chinnamadhu, Archana ; Ramadurai, Prakash ; Suresh, Suganya ; Poomani, Kumaradhas ; Ramakrishnan, Jaganathan

In this COVID-19 pandemic situation, an appropriate drug is urgent to fight against this infectious disease to save lives and prevent mortality. Repurposed drugs and vaccines are the immediate solutions for this medical emergency until discover a new drug to treat this disease. As of now, no specific drug is available to cure this disease completely. Several drug targets were identified in SARS-CoV-2, in which RdRp protein is one of the potential targets to inhibit this virus infection. In-Silico studies plays a vital role to understand the binding nature of the drugs at the atomic level against the disease targets. The present study explores the binding mechanism of reported 53 nucleoside and non-nucleoside RdRp inhibitors and Ivermectin which are in clinical trials. These molecules were screened by molecular docking simulation; in which, the molecules are showing high binding affinity and forming interactions with the key amino acids of active site of RdRp protein are chosen for molecular dynamics simulation (MD) and binding free energy analysis. The results of molecular docking and MD simulation studies reveal that IDX184 is a stable molecule and forms strong interactions with the key amino acids and shows high binding affinity towards RdRp. Hence, IDX184 may also be considered as a potential inhibitor of RdRp after clinical study.Communicated by Ramaswamy H. Sarma.

News (Medical) associated with Lumicitabine

02 Mar 2023

·www.prnewswire.com

Propulsion of Asthma Pipeline as Novel and Extensive 95+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

Asthma is a chronic disease that affects a substantial number of patients worldwide, including children, a number of pharmaceutical companies are involved in developing drugs for asthma. This involvement includes the development of novel therapies that being evaluated in different phases of development. LAS VEGAS, March 2, 2023 /PRNewswire/ -- DelveInsight's ' Asthma Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline asthma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the asthma pipeline domain. Key Takeaways from the Asthma Pipeline Report DelveInsight's asthma pipeline report depicts a robust space with 90+ active players working to develop 95+ pipeline therapies for asthma treatment. Key asthma companies such as Mabpharm Limited, Avillion LLP, GlaxoSmithKline, Immunotek SL, AB Science, AstraZeneca, Inmunotek, Sterna Biologics, Verona Pharma, MediciNova, Foresee Pharmaceuticals, T-Balance Therapeutics, Teva Pharmaceutical Industries, Aldeyra Therapeutics, Trio Medicines, AstraZeneca, Cumberland Pharmaceuticals, Concentrx Pharmaceuticals, Tetherex Pharmaceuticals, SolAeroMed, Palobiofarma, Sanofi, Oneness Biotech, Novartis, Keymed Biosciences, Suzhou Connect Biopharmaceuticals, 4D Pharma Plc, Hoffman-La-Roche, Celltrion, Glenmark Pharmaceuticals, Archivel Farma, Siolta Therapeutics, Areteia Therapeutics, TFF Pharmaceuticals, Evelo Biosciences, Sunshine Guojian Pharmaceutical, Mabwell (Shanghai) Bioscience, Kinaset Therapeutics, Akari Therapeutics, KLUS Pharma, Upstream Bio, LEO Pharma, and others are evaluating new asthma drugs to improve the treatment landscape. Promising asthma pipeline therapies in various stages of development include CMAB007, PT027, GSK3511294, MM09-MG01, Masitinib, Budesonide/Formoterol, BGF MDI, MM09, PT001, SB010, Ensifentrine, Bedoradrine, FP-025, XC8, Tregalizumab, TEV-53275, TEV-48574, ADX-629, TR4, MEDI 3506, Lumicitabine, Ifetroban, Halix(TM) Albuterol, SelK2, S1226, PBF-680, Rilzabrutinib, FB825, FB704A, Dexpramipexole, CSJ117, CM310, CJM112, CBP-201, MRx-4DP0004, RG6314, CT-P39, GBR 310, RUTI, STMC-103H, Voriconazole Inhalation Powder, EDP1867, 610, 9MW1911, KN-002, Nomacopan, A378, Anti mIgE+B-cell, and others. In February 2023, UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) to dexpramipexole, an eosinophil lowering small molecule, that has recently entered Phase III clinical development. Dexpramipexole is beig developed by Areteia Therapeutics to inhibit the maturation and release of eosinophils in bone marrow, based on evidence from cell cultures and human biopsies, thereby lowering peripheral blood eosinophil levels. In February 2023, Pulmatrix, Inc. announced that the first patient dosed in a Phase IIb trial evaluating safety and efficacy of PUR1900 in subjects with Allergic Bronchopulmonary Aspergillosis (ABPA) and asthma. PUR1900 is the company's iSPERSE-enabled dry powder formulation of itraconazole, developed for inhaled pulmonary delivery. The Phase II trial is designed as a randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and duration of treatment with itraconazole, administered as a dry powder for inhalation (PUR1900). Endpoints include safety, tolerability, and potential efficacy outcomes in adult patients with asthma and ABPA. Olatec Therapeutics LLC in February 2023 completed the $40 million Series A round financing, the final closing of which was led by Sanders Morris Harris ("SMH"). Participation in the round came from both existing investors as well as new investors identified by each of Sanders Morris Harris, Advection Growth Capital, and the Company. Proceeds will be principally used to advance Olatec's lead compound, dapansutrile, into later-stage clinical development. Dapansutrile has also been observed to have anti-inflammatory properties and other promising activity in a broad spectrum of over 20 preclinical animal models, including arthritis, asthma, acute myocardial infarction (AMI), heart failure, contact dermatitis, multiple sclerosis, melanoma, pancreatic and breast cancers, spinal cord injury (SCI), Parkinson's and Alzheimer's disease. In January 2023, Avillion LLP, announced that the US Food and Drug Administration (FDA) approved AstraZeneca's Airsupra (albuterol/budesonide, formerly known as PT027) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS). Upstream Bio, in August 2022, initiated a Phase Ib multiple ascending dose study of UPB-101 in asthma patients and successful dosing of the first patient. UPB-101 is a monoclonal antibody designed to block the thymic stromal lymphopoietin receptor (TLSPR) and thus inhibit TSLP-driven inflammation. TSLP is a cytokine and a key driver of inflammatory response in asthma and other allergic and inflammatory diseases. Request a sample and discover the recent advances in asthma drug treatment @ Asthma Pipeline Report The asthma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage asthma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the asthma clinical trial landscape. Asthma Overview Asthma is a chronic disease of the airways. Asthma is characterized by airway inflammation and spasm. Airways are tubes that transport air into and out of the lungs. Asthmatics cause the inside walls of the airways to become sore and swollen. Because of inflammation and tightening of the muscles surrounding the small airways, the airways in the lungs become narrow. Asthma symptoms include coughing, wheezing, shortness of breath, and chest tightness. Asthma symptoms differ from person to person. A person may have infrequent asthma attacks, have symptoms only when exercising, or have symptoms all of the time. Asthma symptoms are similar to those of many respiratory infections. A careful clinical history is the first step in asthma diagnosis; identifying the characteristic symptoms and their duration, intensity, and relationship of symptoms with allergen and triggering agent; and the impact of these symptoms on quality of life. Find out more about drugs for asthma @ New Asthma Drugs A snapshot of the Asthma Pipeline Drugs mentioned in the report: Learn more about the emerging asthma pipeline therapies @ Asthma Clinical Trials Asthma Therapeutics Assessment The asthma pipeline report proffers an integral view of asthma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Asthma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Immunomodulators, Beta 2 adrenergic receptor agonists; Glucocorticoid receptor agonists; Muscarinic receptor antagonists, Interleukin 5 receptor antagonists, Matrix metalloproteinase 12 inhibitors, Aldehyde inhibitors, Bacteria replacements; Microbiome modulators, Thymic stromal lymphopoietin inhibitors; Thymic stromal lymphopoietin modulators, Interleukin-33 inhibitors, Inflammasome inhibitors; Interleukin 1 beta inhibitors; Interleukin 18 inhibitors; Interleukin inhibitors; NLRP3 protein inhibitors, Interleukin-17 inhibitors Key Asthma Companies: Mabpharm Limited, Avillion LLP, GlaxoSmithKline, Immunotek SL, AB Science, AstraZeneca, Inmunotek, Sterna Biologics, Verona Pharma, MediciNova, Foresee Pharmaceuticals, T-Balance Therapeutics, Teva Pharmaceutical Industries, Aldeyra Therapeutics, Trio Medicines, AstraZeneca, Cumberland Pharmaceuticals, Concentrx Pharmaceuticals, Tetherex Pharmaceuticals, SolAeroMed, Palobiofarma, Sanofi, Oneness Biotech, Novartis, Keymed Biosciences, Suzhou Connect Biopharmaceuticals, 4D Pharma Plc, Hoffman-La-Roche, Celltrion, Glenmark Pharmaceuticals, Archivel Farma, Siolta Therapeutics, Areteia Therapeutics, TFF Pharmaceuticals, Evelo Biosciences, Sunshine Guojian Pharmaceutical, Mabwell (Shanghai) Bioscience, Kinaset Therapeutics, Akari Therapeutics, KLUS Pharma, Upstream Bio, LEO Pharma, and others. Key Asthma Pipeline Therapies: CMAB007, PT027, GSK3511294, MM09-MG01, Masitinib, Budesonide/Formoterol, BGF MDI, MM09, PT001, SB010, Ensifentrine, Bedoradrine, FP-025, XC8, Tregalizumab, TEV-53275, TEV-48574, ADX-629, TR4, MEDI 3506, Lumicitabine, Ifetroban, Halix(TM) Albuterol, SelK2, S1226, PBF-680, Rilzabrutinib, FB825, FB704A, Dexpramipexole, CSJ117, CM310, CJM112, CBP-201, MRx-4DP0004, RG6314, CT-P39, GBR 310, RUTI, STMC-103H, Voriconazole Inhalation Powder, EDP1867, 610, 9MW1911, KN-002, Nomacopan, A378, Anti mIgE+B-cell, and others. Dive deep into rich insights for new drugs for asthma treatment; visit @ Asthma Medications Table of Contents For further information on the asthma pipeline therapeutics, reach out @ Asthma Drug Treatment Related Reports Severe Asthma Market Severe Asthma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key severe asthma companies, including AstraZeneca, Novartis, Sanofi, among others. Asthma Pipeline Asthma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including GSK, AstraZeneca, Teva Pharmaceuticals, among others. Severe Asthma Pipeline Severe Asthma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key severe asthma companies, including AstraZeneca, Novartis, Sanofi, among others. Chronic Obstructive Pulmonary Disease Epidemiology Forecast Chronic Obstructive Pulmonary Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic obstructive pulmonary disease epidemiology trends. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key chronic obstructive pulmonary disease companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma, among others. Acute Respiratory Distress Syndrome Pipeline Acute Respiratory Distress Syndrome Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key acute respiratory distress syndrome companies, including Bayer, Faron Pharmaceuticals, BioMarck Pharmaceuticals, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 2Drug ApprovalPhase 3Phase 1

05 Feb 2019

·endpts.com

In a field littered with failures, positive data prompt speedy US, EU review of AstraZeneca’s long-acting RSV drug

The complex molecular structure of the respiratory syncytial virus (RSV) has largely thwarted drugmakers from developing a vaccine or treatment for an infection that afflicts most American infants before their second birthday. But AstraZeneca — the original maker of the only preventative treatment, Synagis, for serious lower respiratory tract infections (LRTI) caused by RSV in infants and young children — has now been offered an expedited review from US and EU regulators for its long-acting RSV drug, MEDI8897. MEDI8897 is under development for prevention of LRTI for a broader patient population than standard-of-care Synagis, which in the US is only approved for high-risk infants. Synagis is also injected monthly in the typically five-month RSV season, while MEDI8897 is designed to be given as a solitary dose. For most older healthy children and adults, RSV causes little discomfort beyond a common cold, but in high-risk groups with compromised immune systems such as infants and the elderly, it can lead to more serious lung and airway infections. But efforts to thwart the infection have culminated in a litany of failures. Most recently, J&J $JNJ terminated Phase IIb trials of its RSV drug lumicitabine and Regeneron $REGN abandoned its RSV drug after a late-stage failure. Novavax $NVAX , whose RSV vaccine failed a Phase III trial in older adults, is expected to report data from another late-stage trial later this quarter of the vaccine’s performance in infants, after their mothers were given the vaccine in the latter stages of their pregnancy. On Tuesday, the FDA granted MEDI8897 breakthrough therapy status , and the treatment also secured access to the EMA’s PRIME (PRIority MEdicines) scheme on the basis of a positive primary analysis of a Phase IIb trial in healthy preterm infants. MEDI8897 is also being evaluated in a late-stage trial in late preterm and healthy full-term infants, and the British drugmaker intends to conduct a separate trial testing the drug in Synagis-eligible pediatric patients to generate additional data for use in this population. In 2017, AstraZeneca $AZN and Sanofi $SNY agreed to jointly develop MEDI8897. Last November, as part of a deal in which AstraZeneca offloaded the Synagis’ US rights to to Swedish Orphan Biovitrum AB (Sobi) for $1.5 billion, Sobi also won the right to participate in AstraZeneca’s share of US profits and losses related to MEDI8897. Sales of Synagis outside the US is the responsibility of AbbVie $ABBV.

Breakthrough TherapyVaccine

17 May 2017

·www.biospace.com

Confident Johnson & Johnson Flexes Its Muscles, Plans 10 Blockbuster Approvals by 2021

May 17, 2017 By Mark Terry , BioSpace.com Breaking News Staff Johnson & Johnson decided to show its pipeline muscle. In meeting with industry analysts, the company indicated it expects to have 10 new products approved between 2017 and 2021 that have blockbuster potential—annual sales of $1 billion each. And if that wasn’t enough, they have more than 50 line extensions on existing and new medicines planned. “With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or the next five years, we are leading the industry in advancing the health of patients around the world,” said Alex Gorsky, J&J’s chairman and chief executive officer , in a statement. “Our pharmaceutical business will continue to be a significant driver of innovation and growth for Johnson & Johnson. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth.” Since 2011, the company and its subsidiary, Janssen Pharmaceutical Companies , has received approval by the U.S. Food and Drug Administration (FDA) for 11 new molecular entities (NMEs). The company’s portfolio is spread amongst five core areas—Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism, and Oncology. It’s planning to add a sixth area, Pulmonary Arterial Hypertension, when it completes the acquisition of Actelion, which should close this quarter. Joaquin Duato , the company’s worldwide chairman for pharmaceuticals, has indicated that J&J hopes to see its branded drug market maintain a 5 percent annual growth through 2020, despite downward pressure on drug pricing. At this point, they’re hoping for three approvals this year and four more in 2018. “These new drugs,” writes John Carroll , for Endpoints News , “are one leg of the company’s three-leg strategy for growing revenue, with a promise that it can improve significantly on existing drugs—like Stelara, Invokana and Xarelto—while beefing up a new core focus on pulmonary arterial hypertension through the Actelion buyout.” The first two drugs that have already been filed are guselkumab for psoriasis and sirukumab for rheumatoid arthritis. The next nine are: • Apalutamide (ARN-509) — the company acquired it when it bought Aragon. It’s for pre-metastatic prostate cancer. • Esketamine — an intranasal version of ketamine for treatment-resistant depression. • Talacotuzumab (JNJ-560222473/CSL362) — for acute myeloid leukemia. • Erdafitinib — an FGFR inhibitor for solid tumors. • Niraparib — for prostate cancer, approved earlier this year in the U.S. as Zejula. • Imetelstat — for myelofibrosis. John Carrol notes, “Geron revealed a few weeks ago that J&J’s review of the data from two studies of its drug imetelstat warranted continued work in myelodysplastic syndromes and myelofibrosis. But the pharma giant JNJ is still reserving the right to quit if the data doesn’t hold up later in the year. That’s not a big vote of confidence.” • Pimodivir (JNJ-3872) — acquired with Vertex in 2014, for influenza A. • Lumicitabine (JNJ-1575) — for respiratory syncytial virus (RSV). • JNJ-7922 (lrexin-2 antagonist) — for adjunctive treatment for major depressive disorder. Johnson & Johnson, of course, is offering this up optimistically as a done deal, but in reality, some of these drugs may not make it past Phase III. Carrol writes, “It’s important to remember that the success rate for Phase III drugs is about 50 percent, and payers have been radically altering the landscape for new drug prices.” On the other hand, J&J has an R&D budget of $7 billion annually, so the company clearly wants investors updated on what’s going on with its spending.

Drug ApprovalAcquisitionPhase 3

100 Deals associated with Lumicitabine

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KEGG	Wiki	ATC	Drug Bank
D11316	Lumicitabine	-	DB14808

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Human Metapneumovirus Infection	Phase 2	United States	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	Japan	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	Argentina	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	Australia	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	Brazil	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	Bulgaria	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	France	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	Malaysia	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	Netherlands	Janssen Research & Development LLC	05 Nov 2018
Human Metapneumovirus Infection	Phase 2	Poland	Janssen Research & Development LLC	05 Nov 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03332459 (CTgov)	Phase 2	Asthma \| Respiratory Syncytial Virus Infections	7	Placebo	ihhwjrhcti = cfpqbpdrcf gzvyswcemq (edielqkooe, zwqxkvgxnz - zmqogibjet) View more	-	13 Apr 2021
NCT02935673 (CTgov)	Phase 2	Respiratory Syncytial Virus Infections	49	LD+Lumicitabine (750 mg LD / 250 mg MD Lumicitabine)	rzxvtdrsqo(xfyxiqntmp) = faodyjfdcb ldqfplkzvx (hnksavzxqv, 545.2) View more	-	24 Dec 2019
				Lumicitabine (1000 mg LD / 500 mg MD Lumicitabine)	rzxvtdrsqo(xfyxiqntmp) = dovqsqmive ldqfplkzvx (hnksavzxqv, 1509) View more
NCT03333317 (CTgov)	Phase 2	Respiratory Syncytial Virus Infections	7	placebo+lumicitabine (Placebo)	tpshoutqlv = lncwuofeyj lvlqjeedeh (xbatwugdch, lglwviirfi - nhhlvfposv) View more	-	05 Dec 2019
				Lumicitabine (Lumicitabine 40/20 mg/kg LD/MD)	tpshoutqlv = lirlyhurce lvlqjeedeh (xbatwugdch, ppjviktlek - gdvkapnxtb) View more
NCT02094365 (Pubmed \| N Engl J Med)	Phase 2	Respiratory Syncytial Virus Infections	62	ALS-008176	icmmhjmtih(btsbfhgoam) = hoqkqtgicv nconqgxlbq (hzomyrtluw )	Positive	19 Nov 2015
				Placebo	icmmhjmtih(btsbfhgoam) = kvdjvheivo nconqgxlbq (hzomyrtluw )

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis