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Patient enrollment ongoing in COMPARE trial evaluating efficacy and safety of SEL-212 vs. KRYSTEXXA® in patients with chronic refractory gout; interim data expected in 4Q19
Preclinical data showing potential for re-dosing of AAV-based vectors when administered in combination with ImmTOR™ (SVP-Rapamycin) presented at ASGCT 22nd Annual Meeting
Company to host conference call today at 8:30 a.m. ET
Initiated 6-Month COMPARE Clinical Trial of SEL-212 vs. Krystexxa: In March 2019, Selecta initiated a six-month head-to-head clinical trial (COMPARE) designed to evaluate the superiority of its lead product candidate, SEL-212 (ImmTOR + Pegadricase), compared to Krystexxa, the current U.S. Food and Drug Administration (FDA)-approved uricase therapy, in adult patients with chronic refractory gout. The COMPARE trial is expected to enroll 150 patients, and the primary endpoint is the maintenance of serum uric acid (sUA) levels of <6mg/dL at six months. An interim six-month data readout is projected in the fourth quarter of 2019 with a full statistical superiority data analysis readout expected in the first quarter of 2020.
Initiation of Phase 3 Clinical Trial of SEL-212 Anticipated in Q4 19: The interim results of the COMPARE trial, which are anticipated in the fourth quarter of 2019, are expected to inform the design of the Phase 3 clinical trial of SEL-212, which the company plans to initiate in the fourth quarter of 2019.
The following information was filed by Selecta Biosciences Inc (SELB) on Thursday, May 9, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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