New Efficacy and Biomarker Data From Rivipansel Phase 3 RESET Trial to Be Presented at Sickle Cell Meeting
- Abstracts for two of GlycoMimetics’ wholly-owned E-selectin inhibitors, rivipansel and GMI-1687, to be published at September meeting of the
The rivipansel abstract includes data from a supportive analysis of the Phase 3 RESET trial of 345 patients (ranging in age from six years to adults, with a mean age of 22 years) who were experiencing acute VOC requiring hospitalization for treatment. The analysis shows that patients treated with rivipansel early in their acute episode experienced a statistically significant improvement on the primary efficacy endpoint, time to readiness for discharge (p=0.03, median improvement was 58 hours). This endpoint reflects achievement of multiple clinical criteria assessing healthcare utilization and a patient’s medical improvement prior to leaving the hospital. Furthermore, patients treated with rivipansel showed a statistically significant reduction in soluble E-selectin, a biomarker indicating that the drug had the intended biological effect. The effect observed on soluble E-selectin in this trial provides valuable insight into the mechanism for the improvement in the clinical criteria for discharge from the hospital observed in those patients treated early in their acute VOC. Data from the RESET trial additionally demonstrate a safety profile for rivipansel comparable to the placebo.
“The important data disclosed today demonstrate that patients treated within approximately 26 hours of the start of a VOC benefited from receiving rivipansel. In addition, the biomarker data showing reductions in soluble E-selectin indicates that rivipansel is hitting its intended biological target. These two findings confirm the critical role of E-selectin in acute vaso-occlusion, as well as the importance of treating individuals early in the course of their acute painful crisis,” said
“The favorable safety profile of rivipansel observed in this trial, as evaluated in a population with pediatric, adolescent, and adult patients, is highly encouraging to us. We are actively considering options for rivipansel in this acute treatment setting, for which there are no approved drugs and, to our knowledge, no drugs currently in late-stage development. Now that Pfizer’s development and commercialization rights, including the investigational new drug (IND) application for rivipansel, have been transferred back to us, we intend to discuss these data with the
The second abstract, accepted for oral presentation, discloses data from a preclinical model of GlycoMimetics E-selectin antagonist, GMI-1687, which is even more potent than rivipansel and is formulated for subcutaneous dosing.
“The data disclosed in this second abstract support development of GMI-1687 as a possible follow-on to rivipansel, which has the potential for subcutaneous self-administration as would be used in an outpatient setting,” continued
About Sickle Cell Disease (SCD) and VOC
SCD is the most common inherited blood disorder in
Rivipansel, a glycomimetic drug candidate that binds to all three members of the selectin family (E-, P- and L-selectin), was GlycoMimetics’ first drug candidate to enter clinical development. After the Phase 3 RESET trial conducted by Pfizer, GlycoMimetics’ former collaborator, produced disappointing results in 2019, new efficacy data from a post hoc analysis of rivipansel were published in
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