Drugs / ensovibep
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04870164 | Nov 2020 → Jan 2022 | COVID-19 | Molecular Partners AG | Terminated | No outcome recorded Stop: Enrollment |
| Phase 21 trial | ||||||
| Phase 2 | NCT04834856 | Apr → Aug 2021 | COVID-19 | Molecular Partners AG | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04828161 | May → Nov 2021 | COVID-19 | Novartis Pharmaceuticals | Terminated | Met primary |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT05780463 | Jun 2021 → Feb 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04501978 | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2023-01-08 | Molecular Partners AG | Regulatory Molecular Partners Provides Updates at 41st Annual JPM Healthcare Conference molecularpartners.com ↗
Molecular Partners was informed by its partner Novartis that it has submitted a request to withdraw the Emergency Use Authorization (EUA) application from the U.S. Food and Drug Administration (FDA) for ensovibep, a DARPin therapeutic candidate to treat COVID-19. |
| 2022-07-21 | Molecular Partners AG | Results Molecular Partners Announces Publication in Nature Biotechnology Detailing Design and Mechanism of Ensovibep DARPin Antiviral for SARS-CoV-2 molecularpartners.com ↗ |
| 2022-02-10 | Molecular Partners AG | Regulatory Emergency Use Authorization Request for Ensovibep Submitted to the US Food and Drug Administration for the Treatment of COVID-19 molecularpartners.com ↗
the company has requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for ensovibep |
| 2022-01-10 | Novartis Pharmaceuticals | Results Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19 novartis.com ↗
Novartis and Molecular Partners today announced that Part A of the EMPATHY clinical trial 1 that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo to treat COVID-19, met the primary endpoint of viral load reduction over eight days. |
| 2022-01-10 | Molecular Partners AG | Results Molecular Partners and Novartis Report Positive Topline Data from Phase 2 Study for Ensovibep (MP0420), a DARPin Antiviral Therapeutic for COVID-19 molecularpartners.com ↗
Topline results from the randomized, placebo-controlled EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo, met the primary endpoint of viral load reduction over eight days |
| 2021-12-06 | Molecular Partners AG | Results Molecular Partners Presents Results from a Phase 2a Trial of Ensovibep in 12 COVID-19 Patients at ESWI 2021 molecularpartners.com ↗
All patients exhibited reductions in viral load and complete COVID-19 clinical symptom recovery |
| 2021-11-16 | Molecular Partners AG | Results Molecular Partners Provides Update from ACTIV-3 Global Clinical Study of Ensovibep in Patients Hospitalized with COVID-19 molecularpartners.com ↗
Following the futility analysis, the independent Data and Safety Monitoring Board (DSMB) recommends that the recruitment of patients in the ensovibep arm of ACTIV-3 not continue in hospitalized patients |
| 2021-10-20 | Molecular Partners AG | Results Molecular Partners Present Data Demonstrating Successful Inhibition of COVID19 Viral Variants with Ensovibep at the 2021 ISIRV-WHO Conference molecularpartners.com ↗
Ensovibep is shown in vitro to maintain inhibition against all variants of concern known to date |
| 2021-07-08 | Molecular Partners AG | Results Molecular Partners Reports Continued Progress of Ensovibep Global Clinical Program; Positive in vitro Data Demonstrating Maintained Inhibition of Delta and All Other Known Variants of Concern of SARS-CoV-2 molecularpartners.com ↗
Ensovibep maintains potency in an in vitro assay and demonstrated full inhibition of all newly emerging known variants of concern, including the Delta variants of concern |
| 2021-05-06 | Molecular Partners AG | Results Molecular Partners’ COVID-19 Antiviral Candidate, Ensovibep, Maintains Potent Neutralization Against Emerging Viral Variants in vitro molecularpartners.com ↗ |
| 2021-03-09 | Molecular Partners AG | Results Molecular Partners and Novartis Report Positive Initial Results from Phase 1 Study of its COVID-19 Antiviral Therapy, Ensovibep, in Healthy Volunteers molecularpartners.com ↗
In each of these cohorts, ensovibep was seen to be safe and well tolerated, with no significant adverse events reported. |
| 2021-02-03 | Molecular Partners AG | Results Molecular Partners and Novartis COVID-19 Antiviral Candidate, Ensovibep, Maintains Binding and Neutralization of New Viral Variants in vitro molecularpartners.com ↗
The study showed that ensovibep maintained very high potency and activity on all tested viral variants and mutants. |
| 2020-12-17 | Molecular Partners AG | Results Molecular Partners Announces New Clinical Data, Immunomodulation Platform Advances, and Virology Portfolio Strategy molecularpartners.com ↗
Data from ongoing phase 1 COVID-19 study show that MP0420 (ensovibep) is well tolerated in first dose cohort |
| 2020-10-06 | Molecular Partners AG | Results Molecular Partners Demonstrates Reduction of Mortality and Potent Therapeutic Activity of Anti-COVID-19 DARPin® Candidates in Advanced COVID-19 Disease Model molecularpartners.com ↗
In the five-day experiment, all animals treated with DARPin® molecules recovered and survived, while 83% of animals in the placebo group had to be euthanized due to severe disease progression. |
All press releases naming this drug 26 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ensovibep | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04834856 ↗ |
| Known as | MP0420 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05780463 ↗ |
| Modality | Protein / enzyme biologic | “Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins” PMID 35939810 ↗ Aug 2022 |
| Route | Intravenous | “INTERVENTION: Intravenous ensovibep, 600 mg, or placebo.” PMID 35939810 ↗ Aug 2022 |