Approval Probability
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Also known as Povetacicept
ALPN-303 · 7 trials · 11 indications
Type, incidence, and severity of TEAE as assessed by CTCAE
| Arm | Type | Description |
|---|---|---|
| Povetacicept | EXPERIMENTAL | Participants will receive Povetacicept every 4 weeks (Q4W) for 104 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to Povetacicept. |
| Phase 2b: Povetacicept | EXPERIMENTAL | Participants will be randomized to receive one of the two doses of Povetacicept. |
| Phase 3: Povetacicept | EXPERIMENTAL | Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b). |
| Phase 3: Calcineurin Inhibitor (CNI) | ACTIVE_COMPARATOR | Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus. |
| Part 1: Povetacicept 240mg | EXPERIMENTAL | Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept. |
| Part 2: Povetacicept Dose A | EXPERIMENTAL | Based on the findings of Part 1, one or two dose levels may be assessed in Part 2; if two dose levels are assessed participants will be randomized to receive one of the two dose levels of Povetacicept. |
| ALPN-303 Regimen A | EXPERIMENTAL | - |
| Placebo Regimen A | PLACEBO_COMPARATOR | - |
| ALPN-303 Regimen B | EXPERIMENTAL | - |
| Placebo Regimen B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Povetacicept | DRUG | Subcutaneous injection administration. |
| Placebo (matched to Povetacicept) | DRUG | Placebo matched to Povetacicept subcutaneous injection administration. |
| Placebo | DRUG | Solution for Subcutaneous Injection. |
| Tacrolimus | DRUG | Capsules for Oral Administration. |
| ALPN-303 | DRUG | Multiple dose levels will be evaluated. |
Key Inclusion Criteria: * Completed the Week 104 visit in the parent study VX24-AIS-D08 (NCT06564142) and has not permanently discontinued study drug * Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 15 milliliters per minute (mL/min)/1.73 square meter (m\^2) within 45 days...
ALPN-303 is an investigational small molecule therapeutic being developed by Vertex Pharmaceuticals Incorporated. It has been studied in a Phase 1 clinical trial in adult healthy volunteers. Its specific disease indications have not been publicly disclosed, and it remains in clinical development rather than approved for any use.
ALPN-303 is being developed by Vertex Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker VRTX. Vertex is the sponsor of the clinical program evaluating ALPN-303, including the Phase 1 study conducted in adult healthy volunteers.
ALPN-303 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational, meaning ALPN-303 has not been approved by the FDA or any other regulatory agency for commercial use.
ALPN-303 has been evaluated in one completed Phase 1 trial, NCT05034484, titled A Study of ALPN-303 in Adult Healthy Volunteers. The trial enrolled 72 participants in Australia, was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older of all sexes.
No, ALPN-303 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development, with one completed Phase 1 trial in adult healthy volunteers. Approval would require successful completion of later-stage clinical trials and regulatory review.