Drugs / OPRX-106
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02107833 | Jul → Dec 2014 | — | Protalix | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02768974 | Sep 2016 → Feb 2017 | ulcerative colitis | Protalix | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-06-05 | Protalix | Results Protalix BioTherapeutics Announces Additional Positive Results from Final Analysis of the Phase II Clinical Trial of OPRX-106 for the Treatment of Ulcerative Colitis protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), announced today that additional positive results from the Company’s phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis (UC) were presented at the Digestive Disease Week® (DDW) 2018 Annual Meeting. |
| 2018-03-13 | Protalix | Results Protalix BioTherapeutics Announces Positive Results from Phase II Clinical Trial of OPRX-106 for the Treatment of Ulcerative Colitis protalix.com ↗
The key efficacy endpoints of the study were met: 67% of patients experienced a clinical response; and 28% of patients experienced a clinical remission. |
| 2018-01-02 | Protalix | Results Protalix BioTherapeutics Reports Positive Interim Data from Phase II Clinical Trial of OPRX-106 in Patients with Ulcerative Colitis protalix.com ↗
Data generated from the first 14 patients who completed the study demonstrates that 57% of the patients achieved clinical response and 36% achieved clinical remission at week 8. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OPRX-106 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02768974 ↗ |
| Modality | Protein / enzyme biologic | “OPRX-106 (TNFR-Fc Fusion Protein)” NCT02107833 ↗ |
| Route | Oral | “oral OPRX-106” NCT02107833 ↗ |