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GB2064

Phase 2

Myelofibrosis | Small molecule | Oncology |Damora Therapeutics, Inc.|Last Updated: Apr 3, 2024

Target and mechanism

Molecular targetLOXL2
Target classEnzyme
ModalitySmall molecule

Also known as PAT-1251

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

GB2064 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT04679870A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With MyelofibrosisMyelofibrosis
ACTIVE NOT_RECRUITING21 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With Myelofibrosis
MyelofibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of GB2064: AE
9 Months

Incidence and severity of adverse events as reported by investigators

Incidence of Treatment-Emergent Adverse Events
one to seven days

Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax)
one to seven days
Area Under the Plasma Concentration Versus Time Curve (AUC)
one to seven days
Time to Maximum Observed Plasma Concentration (Tmax)
one to seven days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GB2064EXPERIMENTALGB2064 will be administered orally as 4 x 250 mg tablets twice a day.
PAT-1251 Single DoseEXPERIMENTALOral solution of PAT-1251, 150 - 4000 mg administered once
Placebo Single DosePLACEBO_COMPARATORMatching placebo solution administered once
PAT-1251 Multiple DoseEXPERIMENTALOral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days
Placebo Multiple DoseEXPERIMENTALMatching placebo tablets administered daily for 7 days

Interventions

NameTypeDescription
GB2064DRUGGB2064 (formerly PAT-1251) is a high-affinity, selective, mechanism-based, small molecule inhibitor of LOXL2, administered twice a day
PAT-1251DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: Participants must satisfy all of the following criteria at the Screening visit: 1. Adult male or female participants ≥ 18 years of age at enrolment: 1. Female participants may be of non-childbearing potential defined as permanently sterile or postmenopausal, or female parti...

Countries:United StatesAustraliaGermanyItalyUnited Kingdom
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Frequently asked questions about GB2064

What is GB2064 used for?

GB2064 is an investigational small molecule being developed for the treatment of myelofibrosis. It is currently in Phase 2 clinical development and is being studied in patients with this condition.

Who is developing GB2064?

GB2064 is being developed by Galecto, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol DMRA.

What phase is GB2064 in?

GB2064 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is currently being evaluated in a Phase 2 clinical trial for myelofibrosis.

What clinical trials is GB2064 in?

GB2064 is being studied in a Phase 2 clinical trial with the identifier NCT04679870. This trial is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral GB2064 in participants with myelofibrosis. The trial is active but not recruiting participants.

How many participants are enrolled in the GB2064 trial?

The Phase 2 clinical trial of GB2064 for myelofibrosis has enrolled 21 participants. The trial is being conducted in the United States, Australia, Germany, and Italy, and includes adults aged 18 years and older.