Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 591 |
| INN | Paridiprubart |
| Status | Clinical |
| Drug code(s) | EB05, NI-0101 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | TLR4 |
| Indications of clinical studies | Acute Respiratory Distress Syndrome, COVID-19, Rheumatoid arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2012 |
| Start of Phase 2 | May 10, 2017 |
| Start of Phase 3 | November 25, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | NovImmune SA |
| Licensee/Partner | Edesa Biotech, Genentech |
| Comments about company or candidate | NCT04401475 Phase 2/3 study suspended in Nov 2024. Edesa has made the decision to suspend this study solely for business reasons. Aug 2024: During Q2 , the company’s anti-TLR4 drug candidate, EB05 (paridiprubart), was selected by the U.S. Department of Health and Human Services for use in a U.S. government-funded platform study investigating novel threat-agnostic host-directed therapeutics in patients with Acute Respiratory Distress Syndrome (ARDS). Edesa is providing drug product for the trial as well as technical support at its own expense. In addition, the company reported today that it plans to continue utilizing its internal resources to advance its vitiligo and pulmonary fibrosis programs, including preparations to file an Investigational New Drug application with the U.S. Food and Drug Administration for a Phase 2 study of its anti-CXCL10 technology in moderate-to-severe vitiligo patients. Fiscal 2nd quarter 2023 results, Edesa reports "Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure." https://feeds.issuerdirect.com/news-release.html?newsid=4892354568451630 Dec 2022: Edesa Biotech, Inc. has received Fast Track designation from the U.S. Food and Drug Administration for its anti-Toll-like receptor 4 monoclonal antibody candidate, EB05. Approval of the company's application follows favorable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome, a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs. August 12, 2022: Edesa Biotech, Inc. reported financial results for the three and nine months ended June 30, 2022 and provided an update on its business. During the quarter, the company expanded an international Phase 3 study of its critical care drug candidate in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS). The company is now recruiting a second cohort of subjects in parallel to its critically severe cohort. June 18, 2021: Edesa Biotech, Inc. reported that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of the company's COVID-19 drug candidate, and based on blinded comparative data, has recommended that the company's international study continue as planned. Nov 30, 2020: Edesa Biotech, Inc., a clinical-stage biopharmaceutical company, announced that the first patient has been enrolled in a Phase 2/3 clinical trial evaluating the company's investigational drug, EB05, as a therapy for hospitalized COVID-19 patients. NCT04401475 Phase 2/3 is Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With Moderate to Severe COVID-19 Pneumonia. Licensed to Edesa Biotech in April 2020 for COVID-19. Aug 2019: No ongoing clinical studies found. July 2019: NovImmune has successfully divested EmaCo AG, a newly established company owning emapalumab and related assets to Sobi on 18 July 2019. NovImmune SA will continue to operate and focus on its bispecific technology and associated programs and will rebrand as Light Chain Bioscience – A brand of Novimmune SA. Listed in NovImmune pipeline accessed online Sep 2 2018. Phase 2 NCT03241108 study in RA started in May 2017 completed in June 2018. Dec 2016: Swiss Biotech firm Novimmune has entered into an option and licence agreement with Roche company Genentech to develop and commercialise its anti-toll-like receptor 4 (TLR4) monoclonal antibody, NI-0101, to treat rheumatoid arthritis and other auto-immune diseases. NCT01808469 Phase 1 completed as of Oct 2014. |
| Full address of company | 15B Chemin du Pré-Fleuri, CH-1228 Plan-Les-Ouates, Switzerland Europe Switzerland https://www.lightchainbio.com/contact/contact-us.html |
Immunoglobulin G1 (326-serine,329-phenylalanine,de-448-lysine), anti-(human toll-like receptor 4) (human-mus musculus monoclonal EB05 gamma1-chain), disulfide with human-mus musculus monoclonal EB05 kappa-chain, dimer
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |