- Source : Globenewswire
- Date : 2019-06-12
- Event type : Phase 2
- Companies : Selecta Biosciences, Inc.
Selecta Biosciences Presents Full Data from Phase 2 Trial of SEL-212 for Chronic Refractory Gout at EULAR 2019
WATERTOWN, Mass., June 12, 2019 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR™, will present full data from the company’s Phase 2 study of SEL-212 for the treatment of chronic refractory gout at the 2019 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, Spain. The poster will be presented on Saturday, June 15, 2019 at 10:30 a.m. CEST (4:30 a.m. EDT).
“We continue to believe SEL-212 has the potential to change the treatment paradigm in chronic refractory gout by fulfilling several unmet needs, including sustained serum uric acid reduction, reduced painful flares and once monthly dosing. These data further position us to execute on our Phase 3 program, which we plan to start later this year,” said Carsten Brunn, CEO of Selecta Biosciences. “With the COMPARE trial now actively enrolling patients, we are excited about the opportunity to demonstrate the superiority of SEL-212 compared to the current FDA-approved uricase therapy.”
SEL-212 is a combination product candidate designed to sustain control of serum uric acid (SUA) levels in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. SEL-212 consists of pegadricase, our proprietary pegylated uricase, co-administered with ImmTOR™, designed to mitigate the formation of anti-drug antibodies (ADAs). ADAs develop due to unwanted immune responses to biologic medicines, rendering these therapies less potent, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout. The data to be presented will show that 66% of evaluable patients (21/32), maintained serum uric acid (SUA) levels of less than 6mg/dL after five once-monthly treatments of SEL-212 at doses of 0.1 or 0.15 mg/kg of ImmTOR in combination with 0.2 mg/kg of pegadricase. The sustained reduction of SUA correlated with inhibition of ADA formation. Furthermore, reduced tissue urate burden, low gout flare rates and severity of flares were observed in the Phase 2 clinical trial. Only 35% of patients treated with five doses of 0.1-0.15 mg/kg of ImmTOR experienced gout flares after initiation during the first month of treatment with continued reduction of gout flare rates over months two through five. No additional patients reported flares after the second month. SEL-212 has been generally well tolerated at clinically active doses following repeated administrations in the trial.
About Chronic Refractory Gout
Gout is the most common form of inflammatory arthritis with more than 8.3 million patients in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues, and can result in flares that cause intense pain. Approximately 160,000 patients in the United States suffer from chronic refractory gout, a painful and debilitating condition in which patients are not able to get their SUA levels below 6 mg/dL and therefore have several flares per year and can develop nodular masses of uric acid crystals known as tophi. Elevated SUA levels have been associated with diseases of the heart, vascular system, metabolism, kidney and joints.
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance technology (ImmTOR) platform. Selecta plans to combine ImmTOR with a range of biologic therapies for rare and serious diseases that require new treatment options due to high immunogenicity. The company’s current proprietary pipeline includes ImmTOR-powered therapeutic enzyme and gene therapy product candidates. SEL-212, the company’s lead product candidate, is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s proprietary gene therapy product candidates are in preclinical development for certain rare inborn errors of metabolism and incorporate ImmTOR with the goal of addressing barriers to repeat administration. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the Company’s plans to present at the EULAR Annual European Congress of Rheumatology, the progress of the clinical development of SEL-212, expectations surrounding the enrollment and design of the Phase 2 head-to-head (COMPARE) clinical trial comparing SEL-212 and Krystexxa®, timing of related data readouts and the ability of the COMPARE results to inform the planned Phase 3 clinical trial of SEL-212, the anticipated timing of the planned Phase 3 clinical trial, whether the head-to-head trial with Krystexxa® will demonstrate superiority, the potential of SEL-212 to fulfill unmet needs in chronic refractory gout patients including sustained SUA reduction, reduced painful flares, and once monthly dosing, the company’s commercial plans, the ability of the company’s ImmTOR platform, including SEL-212, to unlock the full potential of biologic therapies, the potential of SEL-212 to treat chronic refractory gout patients and resolve their debilitating symptoms . All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Such risks and uncertainties include but are not limited to those set forth in the “Risk Factors” section of Selecta’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on May 9, 2019 and in other filings that Selecta makes with the SEC. In addition, any forward-looking statements included in this press release represent Selecta’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. Selecta specifically disclaims any obligation to update any forward-looking statements included in this press release.
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