Drugs / GS030-DP
GS030-DP
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03326336 | Sep 2018 → Oct 2027 expected | retinitis pigmentosa | GenSight Biologics | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2023-02-13 | GenSight Biologics | Results GenSight Biologics Announces 1 Year Safety data and Efficacy signals from PIONEER Phase I/II Clinical Trial of GS030, an Optogenetic Treatment Candidate for Retinitis Pigmentosa gensight-biologics.com ↗
Those results for GS030 are particularly encouraging and could bring back hope for patients suffering from end-stage RP with currently no therapeutic solution. |
| 2021-10-12 | GenSight Biologics | Regulatory GenSight Biologics Announces FDA Grant of Fast Track Designation for Optogenetic Therapy GS030 as Treatment for Retinitis Pigmentosa gensight-biologics.com ↗
GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation to GS030, which combines AAV2-based gene therapy with optogenetics to treat Retinitis Pigmentosa (RP). |
| 2021-09-15 | GenSight Biologics | Results GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I/II Clinical Trial of GS030 as Optogenetic Treatment for Retinitis Pigmentosa gensight-biologics.com ↗
The DSMB found no safety issue in the third cohort of patients, who received an intravitreal injection with the highest dose (5e11 vg) among the three cohorts studied to date, followed by the use of a wearable optronic visual stimulation device. |
| 2021-05-31 | GenSight Biologics | Results GenSight Biologics to Host a Key Opinion Leader Webinar on the Nature Medicine Case Report: Visual Recovery after GS030 Optogenetic Treatment gensight-biologics.com ↗
In addition, GenSight’s management team will discuss highlights from the Nature Medicine Case Report and provide an update on their pipeline candidate, GS030. |
| 2021-05-25 | GenSight Biologics | Results GenSight Biologics Announces Nature Medicine Case Report Showing Visual Recovery after GS030 Optogenetic Treatment gensight-biologics.com ↗
Published in the May issue under the title “ Partial recovery of visual function in a blind patient after optogenetic therapy ”, the paper* is the first peer-reviewed documentation of visual recovery after a blind patient was treated with optogenetic therapy. |
| 2021-02-04 | GenSight Biologics | Results GenSight Biologics Announces the Publication in Communications Biology of the Proof-of-Concept for GS030-Drug Product in Non Human Primates gensight-biologics.com ↗
today announced that the journal Communications Biology has published results from the study of GS030- Drug Product (GS030-DP) in non-human primates (NHP). |
| 2020-04-14 | GenSight Biologics | Results GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I/II Trial of GS030 Combining Gene Therapy and Optogenetics for the Treatment of Retinitis Pigmentosa gensight-biologics.com ↗
The DSMB confirmed the absence of any safety issues for the second cohort of three subjects, who each received a single intravitreal injection of 1.5e11 vg (viral genomes) and used a wearable optronic visual stimulation device after the injection. |
| 2019-05-07 | GenSight Biologics | Results GenSight Biologics announces positive Data Safety Monitoring Board review and continuation of PIONEER Phase I/II clinical trial of GS030 combining gene therapy and Optogenetics for the treatment of Retinitis Pigmentosa gensight-biologics.com ↗
The DSMB confirmed the absence of any safety issues for the first cohort of three subjects who received a single intravitreal injection of 5e10 vg combined with a wearable optronic visual stimulation device. |
| 2018-01-10 | GenSight Biologics | Regulatory GenSight Biologics receives MHRA approval to initiate Phase I/II PIONEER clinical trial of GS030 gene therapy in Retinitis Pigmentosa gensight-biologics.com ↗ |
All press releases naming this drug 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GS030-DP | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03326336 ↗ |
| Known as | GS030-Drug Product | “GS030-Drug Product (GS030-DP) - Recombinant adeno-associated viral vector” NCT03326336 ↗ |
| Known as | rAAV2.7m8-CAG-ChrimsonR-tdTomato | “GS030-Drug Product (GS030-DP) - Recombinant adeno-associated viral vector, derived from serotype 2 (rAAV2.7m8), containing the optimized channelrhodopsin ChrimsonR-tdTomato...” NCT03326336 ↗ |
| Route | Intravitreal | “administered via a single intravitreal injection” NCT03326336 ↗ |