Drugs / EXE-346
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05938465 | Nov 2023 → May 2027 expected | small intestine disorder | Exegi Pharma, LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-12-17 | Exegi Pharma, LLC | Results ExeGi Pharma Positive Topline Results in EXE-346 PROF Phase 1b Study exegipharma.com ↗
Clinical findings from the open-label Phase 1b portion of the trial indicated a reduction in stool frequency of 18% (13.09 daily to 10.69 average daily BMs), and a 28% reduction in average nighttime awakenings (2.39 nightly average to 1.73 BMs) after four weeks of treatment. |
| 2023-01-26 | Exegi Pharma, LLC | Regulatory ExeGi Pharma Announces Clearance of Investigational New Drug (IND) Application for EXE-346 a Live Biotherapeutic Biologic Drug exegipharma.com ↗
ExeGi Pharma LLC, a leader in the development of live biotherapeutic drugs and probiotics, announced today that the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. |
| 2020-11-30 | Exegi Pharma, LLC | Regulatory FDA Orphan Drug Designation for EXE-346 Live Biotherapeutic exegipharma.com ↗
ExeGi Pharma LLC, a company focused on developing live biotherapeutic (“LBP”) drugs and probiotics, announced today that its biologic drug candidate, EXE-346, has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-12-17 | Exegi Pharma, LLC | ExeGi Pharma Positive Topline Results in EXE-346 PROF Phase 1b Study exegipharma.com ↗ |
| 2023-01-26 | Exegi Pharma, LLC | ExeGi Pharma Announces Clearance of Investigational New Drug (IND) Application for EXE-346 a Live Biotherapeutic Biologic Drug exegipharma.com ↗ |
| 2020-11-30 | Exegi Pharma, LLC | FDA Orphan Drug Designation for EXE-346 Live Biotherapeutic exegipharma.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EXE-346 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05938465 ↗ |
| Modality | Other / unclassified | “EXE-346, a live biotherapeutic” NCT05938465 ↗ |
| Route | Oral | “EXE-346 administered orally” NCT05938465 ↗ |