– Top-line statistical results expected mid-2020 –
– Company to meet with FDA in January 2020 regarding Phase 3 clinical development plan –
WATERTOWN, Mass., Dec. 19, 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™, today announced the completion of patient enrollment in the six-month, head-to-head, Phase 2 COMPARE clinical trial. The trial enrolled 150 patients across 49 sites trial and is evaluating the superiority of a once-monthly dose of Selecta’s lead product candidate, SEL-212 (ImmTOR + pegadricase), versus a bi-weekly dose of pegloticase, the current FDA-approved uricase therapy for adult patients with chronic refractory gout. The primary endpoint is maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months. Enrollment in the COMPARE trial commenced in May 2019. Selecta expects to report top-line statistical superiority results by mid-2020.
“There is a demonstrated need for a next-generation treatment for chronic refractory gout, and this trial may reveal important clinical insights that could help physicians best treat patients suffering from this painful, debilitating disease,” said Robert T. Keenan, MD, MBA, MPH, board certified rheumatologist at Duke University School of Medicine and Principal Investigator of the COMPARE trial. “We believe that the speed at which this trial was able to enroll speaks to the significance of the unmet medical need, as well as the need for clinically relevant comparative data to best assess future treatment options for chronic refractory gout patients.”
“Achievement of this enrollment milestone is a testament to the commitment of our clinical investigators and entire team to advancing SEL-212 to address the critical needs of patients with chronic refractory gout, and we are grateful to all of the patients participating in this trial,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta Biosciences. “We are confident that the COMPARE trial will build on the already robust body of SEL-212 data which showed its ability to achieve SUA levels below 6mg/dL, and further the clinical development program for this important therapeutic.”
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.
SEL-212 is a novel 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, Selecta’s 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.
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.
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, statements regarding the progress of the clinical development of SEL-212, the progress and timing of clinical development for ImmTOR for gene therapy, expectations surrounding the enrollment and design of the Phase 2 head-to-head (COMPARE) clinical trial comparing SEL-212 and pegloticase, 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 pegloticase will demonstrate superiority, the unique proprietary technology platform of the company and the unique proprietary platform of its partners, the potential of SEL-212 to fulfill unmet needs in chronic refractory gout patients including sustained SUA reduction, reduced flares, and once monthly dosing, the potential of ImmTOR to enable re-dosing of AAV gene therapy and the potential of ImmTOR generally, anticipated achievement of key milestones for the company’s chronic refractory gout and gene therapy programs, 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, the potential treatment applications for product candidates utilizing the ImmTOR platform in areas such as enzyme therapy and gene therapy, the company’s plan to apply its ImmTOR technology platform to a range of biologics for rare and serious diseases, the potential of the ImmTOR technology platform generally and the company’s ability to grow its strategic partnerships, the sufficiency of the company’s cash, cash equivalents and short-term investments, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, the unproven approach of the company’s ImmTOR technology, potential delays in enrollment of patients, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, changes to the company’s strategy or the inability to effectively implement the company’s strategic plan, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships and, specifically, to reach an agreement regarding an acceptable amendment of the company’s exclusive patent license agreement with the Massachusetts Institute of Technology, its inability to protect its proprietary technology and intellectual property, management’s ability to perform as expected, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the company’s recurring losses from operations and negative cash flows from operations raise substantial doubt regarding its ability to continue as a going concern, substantial fluctuation in the price of its common stock, and other important factors discussed in the “Risk Factors” section of the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, and in other filings that the company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the company’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. The company specifically disclaims any intention to update any forward-looking statements included in this press release.
Joshua R. Mansbach
Lee M. Stern
Source: Selecta Biosciences, Inc.