Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Co-ArgI-PEG, Pegzilarginase, Co-ArgI-PEG modified human arginase I
AEB1102 · 6 trials · 6 indications
The primary analysis will test the change in the level of plasma arginine between baseline and completion of week 24 assessments. It will compare the change from baseline in plasma arginine between participants treated with pegzilarginase and those treated with placebo.
The dose level at which no more than 1/6 patients experiences dose-limiting toxicity
Includes significant changes in hematology, chemistry and coagulation laboratory studies as well as in physical exam and vital signs
the dose level at which no more than 1/6 patients experiences dose-limiting toxicity
1\. Number of participants experiencing treatment-related adverse events as assessed by CTCAE v4.0.
1\. Objective Response Rate (ORR:) per RECIST 1.1 • The Objective Response Rate (ORR) is defined as the percentage of subjects whose best objective response (BOR) is either complete response (CR) or partial response (PR). The ORR will be derived from the BOR according to response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by the Investigator.
| Arm | Type | Description |
|---|---|---|
| Pegzilarginase | EXPERIMENTAL | Weekly IV infusions of pegzilarginase plus individualized disease management for 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Weekly IV infusions of placebo plus individualized disease management for 24 weeks |
| Pegzilarginase Long Term Extension | EXPERIMENTAL | After completion of 24 weeks DB treatment, weekly IV infusions of pegzilarginase plus individualized disease management for an additional 150 weeks, with the option to receive treatment by SC after 8 weeks of the LTE study. |
| AEB1102 | EXPERIMENTAL | Each patient may receive AEB1102 administered IV for up to approximately 4 years. |
| AEB1102 (Co-ArgI-PEG) administered via IV weekly. | EXPERIMENTAL | Co-ArgI-PEG modified human arginase I |
| AEB1102 Dose Escalation Cohort 1 | EXPERIMENTAL | 3 patients dosed at 0.01 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 2 | EXPERIMENTAL | 4 patients dosed at 0.02 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 3 | EXPERIMENTAL | 4 patients dosed at 0.04 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 4 | EXPERIMENTAL | 4 patients dosed at 0.08 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 5 | EXPERIMENTAL | 3 patients dosed at 0.12 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 6 | EXPERIMENTAL | 4 patients dosed at 0.18 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 7 | EXPERIMENTAL | 5 patients dosed at 0.27 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 8 | EXPERIMENTAL | 7 patients dosed at 0.40 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 9 | EXPERIMENTAL | 7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg |
| AEB1102 Expansion | EXPERIMENTAL | Uveal: 11 patients dosed at 0.33 mg/kg Cutaneous Melanoma: 11 dosed at 0.33 mg/kg SCLC: 13 patients dosed at 0.33 mg/kg |
| Pegzilarginase plus Pembrolizumab | EXPERIMENTAL | Phase 1 \& 2 |
| Name | Type | Description |
|---|---|---|
| Pegzilarginase | DRUG | Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated |
| Placebo | DRUG | Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated |
| AEB1102 | DRUG | modified human arginase I |
| Co-ArgI-PEG modified human arginase I | DRUG | - |
| Co-ArgI-PEG | DRUG | Administered IV |
| Pembrolizumab | DRUG | Administered IV |
Inclusion Criteria: Subjects are eligible to be included in the study only if all the following criteria apply: 1. The subject and/or parent/guardian provides written informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
AEB1102 is an investigational small molecule developed by Spyre Therapeutics, Inc. (ticker: SYRE) for the treatment of Arginase I Deficiency, a rare metabolic disorder also associated with hyperargininemia. It is designed to target the enzyme arginase. AEB1102 is in Phase 2 clinical development and has been studied in two completed clinical trials.
AEB1102 is being developed for the treatment of Arginase I Deficiency, a rare inherited metabolic condition that leads to hyperargininemia. It is an investigational therapy and has been evaluated in two completed clinical trials. The trials enrolled patients with Arginase I Deficiency and hyperargininemia, including pediatric patients aged 2 years and older.
AEB1102 targets arginase, an enzyme involved in the urea cycle. By targeting this enzyme, the drug aims to address the metabolic consequences of Arginase I Deficiency. AEB1102 is a small molecule and is being developed by Spyre Therapeutics, Inc. (ticker: SYRE).
AEB1102 is being developed by Spyre Therapeutics, Inc., which trades under the ticker SYRE. The company is responsible for the clinical development of the drug, including the completed Phase 1/2 and Phase 2 trials in patients with Arginase I Deficiency.
AEB1102 is in Phase 2 clinical development. It has not been approved by the FDA and remains an investigational therapy. Two clinical trials have been completed: a Phase 1/2 study and a Phase 2 study. Both trials enrolled patients with Arginase I Deficiency and hyperargininemia.
AEB1102 has been studied in two completed clinical trials: NCT03378531, a Phase 2 study in patients with Arginase I Deficiency, and NCT02488044, a Phase 1/2 study in the same condition. Both trials enrolled patients aged 2 years and older across the United States, Canada, Portugal, and the United Kingdom. No active trials are currently listed.