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-
“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
Sobi has in-licensed SEL-212 from
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 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
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
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.
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.
Source: Selecta Biosciences, Inc.