Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APG777 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| APG777 - Long Term Extension Treatment - 12 Weeks | EXPERIMENTAL | Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201). |
| APG777 - Long Term Extension Treatment - 24 Weeks | EXPERIMENTAL | Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201). |
| APG777 - Open Label Escape Arm | EXPERIMENTAL | Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen. |
| Part A: Induction Period: APG777 | EXPERIMENTAL | Participants will receive APG777 per protocol defined dosing regimen |
| Part A: Induction Period: Placebo | PLACEBO_COMPARATOR | Participants will receive matching Placebo injections per protocol defined dosing regimen |
| Part A: Maintenance Period: APG777 | EXPERIMENTAL | Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen |
| Part B: Induction Period: APG777 | EXPERIMENTAL | Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen |
| Part B: Induction Period: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo injections per protocol defined dosing regimen |
| Part B: Maintenance Period: APG777 | EXPERIMENTAL | Participants will receive APG777 per protocol defined dosing regimen |
| APG777 + APG990 | EXPERIMENTAL | Participants will receive protocol specified combination dose of APG777 + APG990 |
| Dupilumab | ACTIVE_COMPARATOR | Participants will receive protocol specified dose of Dupilumab |
| APG777 | EXPERIMENTAL | Participants will receive protocol specified dose of APG7777 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| APG777 | DRUG | APG777 subcutaneous injection |
| Placebo | DRUG | Matching placebo subcutaneous injection |
| APG990 | DRUG | SC injection |
| Dupilumab | DRUG | SC injection |
Inclusion Criteria: * Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol * Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777 * Use the same non-pres...
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APG777 is an investigational small molecule being developed by Apogee Therapeutics, Inc. for asthma and atopic dermatitis. It is in Phase 1 clinical development and targets IL-13. It has not been approved by the FDA and remains under study in clinical trials.
APG777 is being studied for the treatment of atopic dermatitis and asthma. Clinical trials are enrolling or have enrolled adults with moderate-to-severe atopic dermatitis and adults with asthma. It is investigational and has not been approved for any indication.
APG777 targets IL-13, an inflammatory cytokine involved in type 2 immune responses. By binding IL-13, the small molecule is designed to interfere with signaling that contributes to inflammation in conditions such as atopic dermatitis and asthma.
APG777 is being developed by Apogee Therapeutics, Inc., which trades on the Nasdaq under the ticker APGE. The company is running multiple clinical studies of APG777 in atopic dermatitis and asthma.
APG777 is in Phase 1 clinical development, with additional Phase 2 studies ongoing in atopic dermatitis. It is investigational and has not received FDA approval. The program includes three active trials and no completed trials.
APG777 is being evaluated in NCT06395948 and NCT07003425 in atopic dermatitis, NCT06920901 in asthma, and NCT07027527, which studies APG777 combined with APG990 in moderate-to-severe atopic dermatitis. These trials are randomized, double-blind, and placebo-controlled, with enrollment totaling 906 participants.