First Patient Randomized in the Phase 3 DISSOLVE Clinical Program of SEL-212 for Chronic Refractory Gout
STOCKHOLM, Sweden and WATERTOWN, Mass., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Selecta Biosciences, Inc. (Nasdaq: SELB) today announced the commencement of the phase 3 clinical program of SEL-212 for chronic refractory gout, with the randomization of the first patient in the study.
“We are pleased to have commenced the phase 3 DISSOLVE program evaluating SEL-212 in two phase 3 double-blind, placebo-controlled studies,” said Carsten Brunn, Ph.D., President and CEO of Selecta. “SEL-212 serves as an important validation of Selecta’s ImmTORTM platform, and we are proud to have advanced it into late-stage clinical studies. In partnership with Sobi, we look forward to enrolling patients in the studies and continuing to evaluate SEL-212 as a new, once-monthly treatment option for patients with chronic refractory gout.”
Guido Oelkers, President and CEO of Sobi, added, “SEL-212 has the potential to significantly improve outcomes for patients with chronic refractory gout, and we are proud to have taken the next step towards making this therapy accessible to patients unable to maintain treatment with the currently available options.”
Sobi has in-licensed SEL-212 from Selecta and will be responsible for development, regulatory and commercial activities in all markets outside of China. The phase 3 program for SEL-212 is being run by Selecta and funded by Sobi. Topline data from the Phase 3 clinical program is expected in the second half of 2022. Biologics license application (BLA) filing to the US FDA for SEL-212 is expected in Q1, 2023.
On commencement of this phase 3 program, Sobi will pay a milestone of 5M USD to Selecta.
About the DISSOLVEClinical Program
The phase 3 DISSOLVE clinical program consists of two double-blind, placebo-controlled trials of SEL-212 (NCT04513366), titled “A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy,” in which SEL-212 will be evaluated at two doses of ImmTOR (0.1 mg/kg and 0.15 mg/kg), and one dose of pegadricase (0.2 mg/kg) in both studies. Each trial will aim to enroll 105 patients (35 at each dose level and 35 on placebo). In DISSOLVE I, safety and efficacy will be evaluated at six months and will have a six-month extension. DISSOLVE II will assess safety and efficacy at only the six-month time point, with no extension. The primary endpoint in both studies is serum uric acid levels (SUA) at six months, a well-validated measure of disease severity in chronic refractory gout. Secondary endpoints include tender and swollen joint counts, tophus burden, patient reported outcomes of activity limitation and quality of life and gout flare incidence. For more details about the study, visit clinicaltrials.gov.
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.1 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, may reduce their efficacy and tolerability, 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.1 Elevated SUA levels have been associated with diseases of the heart, vascular system, metabolism, kidney and joints.2
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. The company’s first program aimed at addressing immunogenicity to AAV gene therapies is expected to enter clinical trials in early 2021 in partnership with AskBio for the treatment of methylmalonic acidemia (MMA), a rare metabolic disorder. A wholly-owned program focused on addressing IgA nephropathy driven by ImmTOR and a therapeutic enzyme is also in development among additional product candidates. Selecta recently licensed its Phase 3 clinical program in chronic refractory gout to Sobi. For more information, please visit www.selectabio.com.
Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of hematology, immunology and specialty care indications. Today, Sobi employs approximately 1,400 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi's revenue amounted to SEK 14.2 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.
Selecta Forward-Looking Statements
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, the company’s actions regarding the monitoring and assessment of COVID-19 on the company’s operations, clinical trials and manufacturing, the ability of the company’s ImmTOR platform to unlock the full potential of biologic therapies, the potential treatment applications for product candidates utilizing the ImmTOR platform in areas such as enzyme therapy and gene therapy, the novelty of treatment paradigms that Sarepta is able to develop in combination with the company’s ImmTOR technology, the potential of any therapies developed by Sarepta in combination with the company’s ImmTOR technology to fulfill unmet medical needs, the company’s plan to apply its ImmTOR technology platform to a range of biologics for rare and serious diseases, the clinical development, commercialization, and regulatory activities related to SEL-212 by either the company or Sobi, including with respect to anticipated geographic markets, the anticipated timing of the planned Phase 3 clinical trial, the potential market opportunity for SEL-212, the potential of SEL-212 to fulfill unmet needs in chronic refractory gout patients including sustained SUA reduction, reduced flares, and repeated once monthly dosing, as well as the ability to dose longer than the current standard of care, the company’s and Sobi’s commercial plans, 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 effect of the COVID-19 outbreak on any of the company’s planned or ongoing clinical trials, manufacturing activities, supply chain and operations, 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, 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 as well as the impact of the COVID-19 outbreak on those third parties and their ability to continue their operations, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, 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 including stock market fluctuations that occur as a result of the COVID-19 outbreak, and other important factors discussed in the “Risk Factors” section of the company’s most recent Quarterly Report on Form 10-Q, 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.
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2 Kishimoto TK. Development of ImmTOR Tolerogenic Nanoparticles for the Mitigation of Anti-drug Antibodies. Front Immunol. 2020 May 20;11:969. doi: 10.3389/fimmu.2020.00969.