Drugs / SYN-020
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | radiation enteropathy | 2020-06-30 | “submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its SYN-020” therivabio.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05045833 | Oct 2021 → Feb 2022 | enteritis | Theriva Biologics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04815993 | Mar → May 2021 | enteritis | Theriva Biologics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2022-05-10 | Theriva Biologics, Inc. | Results Synthetic Biologics Reports Positive Safety Data on SYN-020 Intestinal Alkaline Phosphatase Phase 1 Multiple Ascending Dose Clinical Trial therivabio.com ↗
Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile and was well-tolerated across all dose levels. |
| 2021-08-05 | Theriva Biologics, Inc. | Results Synthetic Biologics Reports Second Quarter 2021 Operational Highlights and Financial Results; Conference Call to be Held Today at 4:30 PM ET therivabio.com ↗
Phase 1 Single-Ascending Dose Clinical Trial of SYN-020 Demonstrated Favorable Safety Profile and was Well Tolerated at All Dose Levels |
| 2021-06-29 | Theriva Biologics, Inc. | Results Synthetic Biologics Provides Update on SYN-020 Intestinal Alkaline Phosphatase Phase 1 Single-Ascending Dose Clinical Trial therivabio.com ↗
Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to the study drug. |
| 2020-11-10 | Theriva Biologics, Inc. | Regulatory Synthetic Biologics Reports 2020 Third Quarter Operational Highlights and Financial Results therivabio.com ↗
Received Study-May-Proceed Letter from the FDA Supporting a Phase 1 Single Ascending Dose Study of SYN-020 IAP |
| 2020-08-06 | Theriva Biologics, Inc. | Regulatory Synthetic Biologics Reports 2020 Second Quarter Operational Highlights and Financial Results therivabio.com ↗
We were pleased to report the FDA responded to our Investigational New Drug application (IND) with a study-may-proceed letter to conduct a Phase 1 single ascending dose study of SYN-020 in healthy volunteers. |
| 2020-07-30 | Theriva Biologics, Inc. | Regulatory Synthetic Biologics Announces FDA Clearance of Investigational New Drug Application for SYN-020 Intestinal Alkaline Phosphatase (IAP) therivabio.com ↗ |
| 2020-06-30 | Theriva Biologics, Inc. | Regulatory Synthetic Biologics Announces Submission of IND Application to U.S. FDA for SYN-020 Intestinal Alkaline Phosphatase therivabio.com ↗
Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (“GI”) diseases in areas of high unmet need, today announced that it submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its SYN-020 Intestinal Alkaline Phosphatase (“IAP”) program. |
All press releases naming this drug 11 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 | SYN 020 | “SYN-020 oral delayed release capsules (SYN 020) in healthy adults.” NCT05045833 ↗ |
| Modality | Protein / enzyme biologic | “SYN-020 is a recombinant bovine IAP isotype II” NCT04815993 ↗ |
| Route | Oral | “SYN-020 delayed release capsules administered orally” NCT04815993 ↗ |