Selecta Biosciences Announces Fourth Quarter and Year End 2016
Financial Results and Provides Corporate Update
New Data from Ongoing SEL-212 Phase 2 Trial Show Persistent Clinical Activity After Repeat Administration in Symptomatic Gout Patients
Emerging Clinical and Preclinical Data Confirm the Broad Potential of Selecta’s Immune Tolerance Platform to Enable Biologics that Avoid Unwanted Immunogenicity
Company to Host Conference Call Today at 5:00 p.m. ET
Watertown, Mass., March 27, 2017 - Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biopharmaceutical company focused on developing biologic therapies for rare and serious diseases that avoid unwanted immunogenicity, today reported financial results for the fourth quarter and full year ended December 31, 2016 and provided a corporate update.
“After a pivotal 2016, we believe that 2017 will be a year of great and lasting importance for Selecta Biosciences and for patients with rare and serious diseases,” said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. “While we are still in the early stages of our Phase 2 trial of SEL-212 that was initiated in the fourth quarter of 2016, we are emboldened by its progress and the patient data that have been generated thus far. Patient enrollment has been faster than we expected, and SEL-212 has been generally well tolerated at clinically active doses. We are particularly pleased that we have already reached a dose level of SEL-212 that has thus far enabled all patients that had received a repeat administration to maintain persistent clinical activity. We are eager to collect additional patient data that we believe should be the basis for the development of a major new treatment for severe gout patients.”
“In recent months, we and various collaborators have also presented preclinical data demonstrating the transformative potential of our immune tolerance SVP technology to create novel and differentiated therapies in a number of additional strategic areas such as gene therapy, oncology and enzyme replacement therapy,” continued Cautreels. “We believe SVP has uniquely demonstrated the potential to avoid the immunogenicity that hampers today’s biologic treatments, which is garnering increasing interest throughout the industry.”
SEL-212 Phase 2 Trial Update
Published data show that uricases, exogenous biologic enzymes that metabolize uric acid, have the ability to significantly reduce serum uric acid levels and eliminate uric acid crystal deposits in severe gout patients. However, the efficacy and safety of currently marketed uricases have been compromised by the formation of anti-drug antibodies (ADAs) that are induced in most patients early in their treatment and prevent further administrations. Leveraging the immune tolerance application of Selecta’s SVP platform, SEL-212 (SVP-Rapamycin in combination with pegsiticase) is designed to be the first non-immunogenic version of uricase, which would allow for the effective and safe administration of multiple doses.
A prolonged elevation of serum uric acid levels can lead to the formation of uric acid crystal deposits in joints and tissue. These deposits have been shown to cause severe gout symptoms such as pain, inflammation of joints and debilitating flares, which can potentially exacerbate kidney and cardiovascular disease if untreated. Multi-dose treatment with SEL-212 has the potential to drastically and durably lower serum uric acid levels, enabling the
The following information was filed by Selecta Biosciences Inc (SELB) on Monday, March 27, 2017 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Form Type: 10-K Annual Report Accession Number: 0001453687-17-000014 Submitted to the SEC: Mon Mar 27 2017 9:50:11 PM EST Accepted by the SEC: Tue Mar 28 2017 Period: Saturday, December 31, 2016 Industry: Pharmaceutical Preparations