We Aim to Bring Much-Needed Medicines to Patients as Quickly and Efficiently as Possible

We are advancing a growing pipeline of investigational medicines with the goal of treating a range of cancers and genetic diseases that have largely eluded other targeted approaches. We currently have one investigational medicine in a Phase 2 clinical trial.

SY-1425 for Genomically Defined Subsets of AML Patients

SY-1425 is an oral, first-in-class selective retinoid acid receptor alpha (RARĪ±) agonist that is currently in a Phase 2 clinical trial in combination with a standard-of-care therapy known as azacitidine in patients with acute myeloid leukemia (AML).

Initial data from the ongoing Phase 2 trial showed that SY-1425 in combination with azacitidine had high response rates and rapid onset of responses in AML patients who are positive for our RARA or IRF8 biomarkers. The initial data also showed that SY-1425 in combination with azacitidine was generally well-tolerated with no increase in toxicities beyond what has been previously seen with either agent alone. These initial clinical data, coupled with preclinical data showing the tumor-killing activity of SY-1425 in combination with azacitidine, lead us to believe that SY-1425 may have broad potential as a combination agent for biomarker-positive AML patients. We estimate that about one-third of AML patients have one or both of these biomarkers.

The ongoing Phase 2 clinical trial is a multi-center, open-label trial exploring safety and efficacy of SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy regardless of their biomarker status, as well as in RARA or IRF8 biomarker-positive relapsed or refractory AML patients. The primary endpoint of the trial is overall response rate. The trial will also assess duration of response, safety and tolerability, and survival.


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Interested in Learning More about How Clinical Trials Work?

Clinical trials are an important part of helping bring safe and effective medicines to patients. For patients who lack effective treatments, clinical trials are also an opportunity to be a part of testing a new drug. By taking part in clinical trials, patients can make an important contribution to ongoing research and better understanding of a disease.

Learn more about participating in clinical trials

Access to Investigational Products Outside of a Clinical Trial

Syros has adopted a policy that describes the guidelines by which it will consider requests for access to one of its investigational products outside of a clinical trial.

You can review that policy here