First patient randomised in the phase 3 DISSOLVE clinical programme of SEL-212 for Chronic Refractory Gout
- Category: Proteins and Peptides
- Published on Wednesday, 23 September 2020 18:39
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STOCKHOLM, Sweden and WATERTOWN, MA, USA I September 23, 2020 I 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 DISSOLVE Clinical 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.