Drugs / QUISOVALIMAB
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03169894 | Jul 2017 → Sep 2021 | Crohn disease, ulcerative colitis | Avalo Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05288504 | Feb 2022 → May 2023 | asthma | Avalo Therapeutics, Inc. | Completed | Missed primary |
| Phase 2 | NCT04412057 | Jul → Dec 2020 | acute lung injury, adult acute respiratory distress syndrome, pneumonia | Aevi Genomic Medicine, LLC, a Cerecor company | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2023-08-03 | Avalo Therapeutics, Inc. | Results Avalo Reports Second Quarter 2023 Financial Results and Provides Business Updates August 03, 2023 7:00am EDT avalotx.com ↗
Although the PEAK trial did not meet its primary endpoint, mechanistically I believe AVTX-002 has promise in other inflammatory driven diseases including IBD and other diseases of the lung, gut and skin. |
| 2023-06-26 | Avalo Therapeutics, Inc. | Results Avalo Announces Topline Data from Phase 2 PEAK Trial for AVTX-002 (quisovalimab) in Patients with Non-Eosinophilic Asthma June 26, 2023 7:00am EDT avalotx.com ↗
The trial did not meet its primary endpoint, measured by the reduction in asthma-related events. |
| 2022-01-06 | Avalo Therapeutics, Inc. | Results Avalo Reports Positive Phase 1b Results for AVTX-002 in Moderate to Severe Crohn's Disease Patients and Presents Additional Program Updates at 2022 Investor Event January 06, 2022 7:30am EST avalotx.com ↗ |
| 2021-08-02 | Avalo Therapeutics, Inc. | Results Cerecor Reports Second Quarter 2021 Financial Results and Provides Business Updates August 02, 2021 4:01pm EDT avalotx.com ↗
Announced positive results for low-dose cohort of CERC-002 (1.0 mg/kg) in moderate-to-severe Crohn's disease patients who had previously failed three or more lines of biologic therapies, including anti-TNF alpha treatments |
| 2021-07-26 | Avalo Therapeutics, Inc. | Results Cerecor Announces Positive Initial Phase 1b Results for CERC-002 in Moderate to Severe Crohn's Disease Patients July 26, 2021 4:01pm EDT avalotx.com ↗ |
| 2021-05-13 | Avalo Therapeutics, Inc. | Regulatory Cerecor Reports First Quarter 2021 Financial Results and Provides Business Updates May 13, 2021 7:00am EDT avalotx.com ↗
The U.S. Food and Drug Administration (FDA) granted Fast Track designation to CERC-002 for the treatment of hospitalized COVID-19 patients. |
| 2021-05-11 | Avalo Therapeutics, Inc. | Regulatory FDA Grants Fast Track Designation to CERC-002 for Treatment of Hospitalized Patients with COVID-19 May 11, 2021 7:00am EDT avalotx.com ↗
Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CERC-002 for treatment of hospitalized patients with COVID-19. |
| 2021-03-02 | Avalo Therapeutics, Inc. | Results Cerecor Announces CERC-002 Significantly Reduced Respiratory Failure and Mortality in Phase 2 Clinical Trial in Patients Hospitalized with COVID-19 ARDS March 02, 2021 7:00am EST avalotx.com ↗ |
| 2021-01-05 | Avalo Therapeutics, Inc. | Results Cerecor Announces Successful Proof of Concept Data for CERC-002, a Unique LIGHT-Neutralizing Antibody, in Patients Hospitalized with COVID-19 ARDS January 05, 2021 7:00am EST avalotx.com ↗
28-day mortality was reduced by approximately 50% in patients treated with CERC-002 (3 patients) vs. placebo (6 patients). |
| 2020-05-28 | Avalo Therapeutics, Inc. | Regulatory Cerecor Announces FDA Clearance of IND for CERC-002 in COVID-19 Induced ARDS May 28, 2020 7:00am EDT avalotx.com ↗ |
All press releases naming this drug 15 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | QUISOVALIMAB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802198 ↗ |
| Known as | AEVI-002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802198 ↗ |
| Known as | AVTX-002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05288504 ↗ |
| Known as | CERC-002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04412057 ↗ |
| Known as | KHK-252067 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802198 ↗ |
| Known as | MDGN-002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03169894 ↗ |
| Known as | SAR-252067 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802198 ↗ |
| Action | Inhibit | “For patients with COVID-19-associated ARDS, adding CERC-002 to standard-of-care treatment reduces LIGHT levels” PMID 34871182 ↗ Feb 20221“Tumor necrosis factor ligand superfamily member 14 inhibitor” CHEMBL4802198 ↗ |
| Modality | Monoclonal antibody | “fully human IgG4 monoclonal antibody” NCT03169894 ↗ |
| Route | Subcutaneous | “MDGN-002 will be administered by SQ injection in the abdomen every 14 days at 1 of 2 dose levels: 1.0 mg/kg or 3.0 mg/kg.” NCT03169894 ↗ |
| Target | TNFSF14 | “Tumor necrosis factor ligand superfamily member 14 inhibitor” CHEMBL4802198 ↗ |