Approval Probability
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4D-110 · 1 trial · 1 indication
Frequency and severity of ocular and systemic AEs including clinically significant changes in ocular evaluations, systemic examinations and laboratory testing.
| Arm | Type | Description |
|---|---|---|
| 4D-110 Dose 1 | EXPERIMENTAL | 4D-110 IVT injection |
| 4D-110 Dose 2 | EXPERIMENTAL | 4D-110 IVT injection |
| 4D-110 Dose 3 | EXPERIMENTAL | 4D-110 IVT injection |
| Name | Type | Description |
|---|---|---|
| 4D-110 | BIOLOGICAL | 4D-110 drug product developed for gene therapy which comprises an AAV capsid variant (4D-R100) carrying a transgene encoding a codon-optimized human CHM gene. |
Key Inclusion Criteria: * Diagnosis of CHM defined as a pathogenic mutation in the CHM gene, confirmed by genetic testing * Both eyes must have ≥ 34 ETDRS letters (\~20/200) Key Exclusion Criteria: * Clinically significant, active ocular or peri-ocular infection or inflammation in the study eye *...
4D-110 is an investigational therapy being developed for the treatment of choroideremia, a rare inherited retinal disease that primarily affects males. It is administered via intravitreal injection and is currently in clinical development for this condition.
4D-110 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat choroideremia, a condition caused by mutations in the CHM gene, though the exact mechanism of action for 4D-110 is not specified.
4D-110 is being developed by 4D Molecular Therapeutics, Inc., a biopharmaceutical company publicly traded under the ticker symbol FDMT. The company is conducting clinical trials to evaluate the safety and efficacy of 4D-110 in patients with choroideremia.
4D-110 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is a dose escalation study designed to assess the safety and tolerability of the drug in patients with choroideremia.
4D-110 is being evaluated in a Phase 1 clinical trial with the identifier NCT04483440, titled "Dose Escalation Study of Intravitreal 4D-110 in Patients With Choroideremia." The trial is active but not recruiting, with an enrollment of 13 male participants aged 18 years and older in the United States.