Selecta Biosciences and Sobi Announce Completion of Enrollment in DISSOLVE Phase 3 Study Evaluating SEL-212 for Chronic Refractory Gout
-DISSOLVE program on track with 12-month study fully enrolled-
-DISSOLVE II on track for full enrollment in early 2022-
-Top-line data from Phase 3 DISSOLVE program expected in H2 2022-
WATERTOWN, Mass. and STOCKHOLM, Sweden, Dec. 01, 2021 (GLOBE NEWSWIRE) — Selecta Biosciences, Inc. (NASDAQ: SELB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI), today announced the completion of enrollment for DISSOLVE I, the first of two clinical studies of the phase 3 DISSOLVE development program of SEL-212 for chronic refractory gout. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).
“The completion of enrollment for the DISSOLVE I study of our phase 3 DISSOLVE program is an important step forward in advancing SEL-212 as a potential new, once-monthly treatment option for people suffering from chronic refractory gout,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. “We are continuing enrollment in the DISSOLVE II study, and we remain on track to share top-line results from the DISSOLVE clinical program in 2H 2022. Our pipeline builds on the learnings from this program and shows the potential of ImmTOR to overcome unwanted immunogenicity, mitigate detrimental immune responses against enzyme or gene therapies, and provide real change for people with autoimmune diseases.”
Guido Oelkers, President and Chief Executive Officer of Sobi, added, “We are pleased that the DISSOLVE program is progressing, and we believe that the less burdensome treatment regimen of the potential new medicine SEL-212 will improve the lives of those suffering from chronic refractory gout. We are proud to collaborate with Selecta as we continue to deliver on our shared vision to advance innovative medicines and improve the lives of people with rare diseases.”
Sobi has in-licensed SEL-212 from Selecta and is 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.
DISSOLVE clinical program
The phase 3 DISSOLVE clinical program consists of two double-blind, placebo-controlled studies of SEL-212, 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 study will enroll up to 120 people (with up to 40 people at each dose level and 40 people on placebo). In DISSOLVE I, safety and efficacy will be evaluated at six months and will have a six-month extension to evaluate safety. 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 (SUA) control during month six, 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 (NCT04513366).
SEL-212
SEL-212 is a novel combination medicine designed to sustain SUA levels in people 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, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout.
Chronic refractory gout
Gout is the most common form of inflammatory arthritis with more than 8.3 million people 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 people in the United States suffer from chronic gout refractory to conventional medicines, a painful and debilitating condition in which people 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
Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage biotechnology company leveraging its 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. Selecta has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. Selecta Biosciences is headquartered in the Greater Boston area. For more information, please visit www.selectabio.com.
Sobi
Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative medicines in the areas of Haematology, Immunology and specialty indications. Sobi employs approximately 1,500 people across Europe, North America, the Middle East, Russia and Asia. In 2020, Sobi’s revenues amounted to SEK 15.3 billion. Sobi’s share (STO: SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at 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, statements regarding the unique proprietary technology platform of the Company, and the unique proprietary platform of its partners, the programs and disease indication targets anticipated under this agreement, the timing of clinical trials, including any data readouts, the ability of any drug candidate developed under the agreement to offer a therapeutic benefit, the potential of SEL-212 to treat chronic refractory gout or to be a once-monthly treatment, , the potential treatment applications of product candidates utilizing the ImmTOR platform in areas such as chronic refractory gout, the ability of the Company and its partners where applicable to develop products using ImmTOR, the novelty of treatment paradigms that the Company is able to develop, the potential of the ImmTOR technology platform generally and the Company’s ability to grow its strategic partnerships, 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 unproven approach of the Company’s ImmTOR technology, our partners’ ability to develop products under the agreement, undesirable side effects of the Company’s technology, its reliance on third parties to manufacture its product candidates and to conduct its development activities, 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, 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 most recent Annual Report on Form 10-K to be filed after this release, 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.
For more information, please contact:
Sobi
To contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.
Selecta
For investors:
Bruce Mackle
LifeSci Advisors, LLC
+1-929-469-3859
bmackle@lifesciadvisors.com
For media:
Brittany Leigh, Ph.D.
LifeSci Communications, LLC
+1-646-751-4366
bleigh@lifescicomms.com
1https://www.sec.gov/ix?doc=/Archives/edgar/data/1453687/000145368720000096/selectabiosciences10-q.htm
2 Lee, S.J., Oh, B.K. & Sung, K. Uric acid and cardiometabolic diseases. Clin Hypertens 26, 13 (2020). https://doi.org/10.1186/s40885-020-00146-y.
