Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CPK850 · 1 trial · 1 indication
Safety events
A patient is considered a responder if sensitivity recovery values at 1 hour post-bleach are observed to be outside of the patient's prediction interval at ≥2 consecutive post-treatment visits within one year after treatment.
| Arm | Type | Description |
|---|---|---|
| CPK Dose 1 (lowest dose) | EXPERIMENTAL | CPK850, one subretinal injection to the study eye |
| CPK Dose 2 (next lowest dose) | EXPERIMENTAL | CPK850, one subretinal injection to the study eye |
| CPK Dose 3 (third lowest dose) | EXPERIMENTAL | CPK850, one subretinal injection to the study eye |
| CPK Dose 4 (highest dose) | EXPERIMENTAL | CPK850, one subretinal injection to the study eye |
| Name | Type | Description |
|---|---|---|
| CPK850 | BIOLOGICAL | In one of 4 dose levels administered via subretinal injection under anesthesia |
Inclusion Criteria: * Male and female patients aged 18 to 70 years inclusive. * The visual acuity in the study eye at the screening 1 visit should be no better than 60 ETDRS letters. * Clinical diagnosis of Bothnia dystrophy, Newfoundland rod-cone dystrophy or other progressive retinitis pigmentosa...
CPK850 is an investigational monoclonal antibody being developed for retinitis pigmentosa, a group of inherited eye disorders that cause progressive vision loss. It is being studied in patients with RLBP1 retinitis pigmentosa, a specific genetic form of the condition. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
CPK850 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research on this investigational therapy for retinitis pigmentosa.
CPK850 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for retinitis pigmentosa.
CPK850 has one completed clinical trial registered under NCT03374657, titled "A First-in-human, Proof of Concept Study of CPK850 in Patients With RLBP1 Retinitis Pigmentosa." This Phase 1 study enrolled 12 participants in Sweden and included adults aged 18 years and older of all sexes.
CPK850 is a monoclonal antibody, a type of protein designed to bind to a specific target in the body. The exact molecular target of CPK850 has not been disclosed in available information. The drug is being investigated for its potential role in treating retinitis pigmentosa, though its precise mechanism of action remains under study.
No alternative names for CPK850 have been reported. The drug is identified solely by its code name CPK850 in clinical trial registrations and available information. It is a distinct investigational monoclonal antibody being developed by Novartis for retinitis pigmentosa.