Drugs / THR-149
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03511898 | May 2018 → May 2019 | diabetes mellitus, diabetic macular edema | ThromboGenics | Completed | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT04527107 | Jul 2020 → Sep 2023 | diabetes mellitus, diabetic macular edema | Oxurion | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2023-11-20 | ThromboGenics | Results Oxurion Discloses Topline Data from KALAHARI Phase 2, Part B Trial of Novel PKal Inhibitor THR-149 in Diabetic Macular Edema oxurion.com ↗
The mean change in best corrected visual acuity (BCVA) from baseline at Month 3 was -0.2 letters for the THR-149 arm and +3.5 letters for the aflibercept arm. |
| 2022-06-13 | ThromboGenics | Results Oxurion Announces Two Presentations at The Macula Society 45th Annual Meeting oxurion.com ↗
A mean BCVA gain of 6.1 letters was seen at Month 3, with gains observed up to Month 6 as well as CST stabilization over the 6-month study period compared to Baseline |
| 2022-06-07 | ThromboGenics | Results Oxurion Announces Preclinical Presentation on THR-149 at KININ2022 oxurion.com ↗
IVT-PK and IV-PK data were analyzed based on a mono-compartmental pharmacokinetic model, leading to ocular and systemic half-lives of 36 h and 1.1 h, respectively. |
| 2022-02-14 | ThromboGenics | Results Oxurion Announces New Data on THR-149 Phase 2 Clinical Trial (“KALAHARI”) in DME at the Angiogenesis, Exudation, and Degeneration 2022 Conference oxurion.com ↗
Post-hoc analysis reveals >9 letter gain in mean BCVA that was maintained for the remaining four months of the trial after the last THR-149 injection with no rescue treatment required |
| 2021-10-11 | ThromboGenics | Results Positive Phase 2 Part A THR-149 data shared at the America Society of Retina Specialists (ASRS) Annual Scientific Meeting oxurion.com ↗
The highest dose delivered a mean 6.1 letter improvement at Month 3 with no patients requiring rescue medications. |
| 2021-09-30 | ThromboGenics | Results OXURION Announces Positive Results from Part A of Phase 2 Study Evaluating THR-149 for Treatment of Diabetic Macular Edema (DME) oxurion.com ↗
Based on these data the Company has decided to move the highest dose of THR-149 (0.13mg) into Part B of the study, which is expected to begin shortly. |
| 2021-08-16 | ThromboGenics | Results Oxurion NV – Journal of Pharmacokinetics and Pharmacodynamics highlights desirable PK/PD profiles of THR-687 and THR-149 oxurion.com ↗
THR-149 and THR-687 show targeted activity in the eye following intravitreal injection with low systemic exposure |
| 2019-10-09 | ThromboGenics | Results Oxurion NV to Provide Business and Clinical Update at Upcoming American Academy of Ophthalmology annual meeting (AAO) and Ophthalmology Innovation Summit (OIS @AAO) in San Francisco oxurion.com ↗ |
| 2019-09-09 | ThromboGenics | Results Oxurion NV Reports Additional Positive Topline Data from Phase 1 with THR-149, a novel, potent plasma kallikrein inhibitor for DME oxurion.com ↗
No dose-limiting toxicities nor drug-related serious adverse events were reported at any of the dosages evaluated in the study. |
| 2019-09-02 | ThromboGenics | Results Oxurion to make a late-breaker presentation of topline THR-149 (Plasma Kallikrein inhibitor) Phase 1 clinical data at EURETINA 2019 oxurion.com ↗
Oxurion to make a late-breaker presentation of topline THR-149 (Plasma Kallikrein inhibitor) Phase 1 clinical data at EURETINA 2019 |
| 2019-07-01 | ThromboGenics | Results Oxurion NV Reports Positive Topline Phase 1 Results with THR-149, a novel, potent plasma kallikrein inhibitor for the treatment of DME oxurion.com ↗ |
| 2019-07-01 | BicycleTx Limited | Results Bicycle Therapeutics Announces Positive Topline Results from Oxurion’s Phase I Trial Using a Novel Bicycle-based Plasma Kallikrein Inhibitor for the Treatment of Diabetic Macular Edema bicycletherapeutics.com ↗
A rapid onset of action was observed from Day 1, with an increasing average improvement in BCVA of up to 7.5 letters at Day 14. |
| 2019-02-28 | ThromboGenics | Results Oxurion NV to Present Preclinical Evaluation of Plasma Kallikrein Inhibition for DME at 2019 EURETINA Winter Meeting oxurion.com ↗
These positive results highlight THR-149’s potential as a treatment option for diabetic macular edema (DME). |
| 2018-04-06 | ThromboGenics | Results ThromboGenics announces publication in The Journal of Medicinal Chemistry of preclinical data supporting therapeutic potential of THR-149 oxurion.com ↗
The preclinical study confirmed that the bicyclic peptides have nano molar to picomolar potencies, are stable in biological matrices and reported prolonged retention in the eye together with in vivo efficacy in diabetic models of retinal vascular permeability. |
All press releases naming this drug 27 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | THR-149 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03511898 ↗ |
| Route | Intravitreal | “single intravitreal injection” NCT03511898 ↗ |