Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LKA651 · 2 trials · 4 indications
An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation patient. The severity of the AEs (mild, moderate, severe) was based on the Common Terminology Criteria for Adverse Events (CTCAE). Number of participants in each category is reported in the table. A participant who falls multiple times in one category is counted only once.
An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation patient.
An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation patient.
Intraocular pressure was measured per the study site's regular practice.
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. BCVA in study eye was analyzed with a mixed model for repeated measures. The model included treatment, visit, and the treatment by visit interaction as independent variables. An unstructured residual covariance structure was used. Baseline BCVA value and treatment naïve and treatment experienced variable were used as covariates. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Foveal avascular zone was assessed by fluorescein angiography (FA).
Central subfield thickness was measured by spectral domain optical coherence tomography (SD-OCT). Central subfield retinal thickness was analyzed with a mixed model for repeated measures. The model included treatment, visit, and the treatment by visit interaction as independent variables. An unstructured residual covariance structure was used. Log-transformed baseline central subfield retinal thickness and treatment naïve and treatment experienced variable were used as covariates. Results were back-transformed to show results as a ratio to baseline.
To evaluate the safety and tolerability of LKA651 by reviewing any adverse events after medical or ophthalmic examinations that are possibly or probably related to study drug.
| Arm | Type | Description |
|---|---|---|
| LKA651 | EXPERIMENTAL | LKA651 Intravitreal injection |
| LKA651 + Lucentis | EXPERIMENTAL | LKA651 + Lucentis Intravitreal injection |
| Lucentis | ACTIVE_COMPARATOR | Lucentis Intravitreal injection |
| Sham Comparator | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| LKA651 | DRUG | LKA651 5 mg Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase |
| Lucentis | DRUG | Lucentis 0.3 mg (U.S. sites) or 0.5 mg (ex U.S. sites) Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase |
| Sham Comparator | OTHER | - |
Inclusion Criteria * Written informed consent must be obtained before any assessment is performed. * Male and female patients age 18 to 85 years of age inclusive at screening * Presence of type I or type II diabetes mellitus * The Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
LKA651 is an investigational small molecule being developed for diabetic macular edema and macular edema. It has been studied in patients with macular edema, diabetic macular edema, neovascular age-related macular degeneration, and retinal vein occlusions.
LKA651 is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamic activity when administered intravitreally.
LKA651 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS.
LKA651 has completed a Phase 1 trial and a Phase 2 trial. It is an investigational drug and has not been approved by regulatory authorities. Its clinical development program includes studies in diabetic macular edema and other retinal conditions.
LKA651 has been studied in two completed clinical trials. NCT02867735 was a Phase 1 study in patients with macular edema, diabetic macular edema, neovascular age-related macular degeneration, and retinal vein occlusions. NCT03927690 was a Phase 2 multiple-dose study in patients with diabetic macular edema.
LKA651 is not known to have alternative names. It is a distinct investigational compound developed by Novartis AG for the treatment of retinal conditions associated with macular edema.