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Co-ArgI-PEG modified human arginase I

Phase 2

Acute Myeloid Leukemia | Small molecule | Oncology |Spyre Therapeutics, Inc.|Trials Updated: Jul 27, 2023

Co-ArgI-PEG modified human arginase I development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Apr 2001

Co-ArgI-PEG modified human arginase I target and mechanism

ModalitySmall molecule

Also known as AEB1102

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment59

FDA Designations

No designations recorded

Co-ArgI-PEG modified human arginase I clinical trials

Co-ArgI-PEG modified human arginase I · 3 trials · 4 indications

Phase 2 2Phase 1 1
NCT03378531A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I DeficiencyArginase I Deficiency
COMPLETED14 Analytics
NCT02732184A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDSAcute Myeloid Leukemia
COMPLETED29 Analytics
PHASE2COMPLETED
A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency
Arginase I DeficiencyUnlock trial analytics
PHASE2COMPLETED
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-related adverse events
up to 4 years
Maximum Tolerated Dose and Recommended Phase 2 Dose
4 weeks

The dose level at which no more than 1/6 patients experiences dose-limiting toxicity

Number of subjects with adverse events
weekly throughout the study, up to 14 weeks

Includes significant changes in hematology, chemistry and coagulation laboratory studies as well as in physical exam and vital signs

Secondary Endpoints

Cmax Cmin
up to 4 years
Safety profile (changes in physical exam, laboratory measures, reported adverse events)
4 Weeks
Number of subjects with a decrease from baseline in plasma arginine level
Baseline to 2, 4, 6, 8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEB1102EXPERIMENTALEach patient may receive AEB1102 administered IV for up to approximately 4 years.
AEB1102 (Co-ArgI-PEG) administered via IV weekly.EXPERIMENTALCo-ArgI-PEG modified human arginase I

Interventions

NameTypeDescription
AEB1102DRUGmodified human arginase I
Co-ArgI-PEG modified human arginase IDRUG -
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Complete treatment in Study CAEB1102-101A without experiencing any clinically significant adverse event or other unmanageable drug toxicity that would preclude continued dosing 2. Confirmation by the Investigator and the Sponsor determine that it is acceptable for the patient...

Countries:United StatesCanadaPortugalUnited Kingdom
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Frequently asked questions about Co-ArgI-PEG modified human arginase I

What is Co-ArgI-PEG modified human arginase I used for?

Co-ArgI-PEG modified human arginase I is an investigational small molecule being developed for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 2 clinical development and has been studied in patients with AML or Myelodysplastic Syndrome.

Who makes Co-ArgI-PEG modified human arginase I?

Co-ArgI-PEG modified human arginase I is being developed by Spyre Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SYRE.

What phase is Co-ArgI-PEG modified human arginase I in?

Co-ArgI-PEG modified human arginase I is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is Co-ArgI-PEG modified human arginase I in?

Co-ArgI-PEG modified human arginase I has been studied in a completed Phase 2 trial with the identifier NCT02732184. This trial was a multiple dose, dose escalation study in patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome, enrolling 29 participants in the United States and Canada.

Is Co-ArgI-PEG modified human arginase I the same as AEB1102?

Yes, Co-ArgI-PEG modified human arginase I is also known as AEB1102. The clinical trial NCT02732184, which evaluated this drug, was titled 'A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS'.