Selecta Biosciences Announces Partnership Advancements and Clinical Trial Updates
-Enrollment in DISSOLVE II, the Phase 3 study evaluating SEL-212 for chronic refractory gout, continues to advance with full enrollment anticipated by the end of Q2 2022. The achievement of this milestone would trigger a
-DISSOLVE I & II studies remain on track for completion in Q4 2022 with joint topline data in Q1 2023-
Extension of Sarepta’s Research License and Option Agreement
Sarepta Therapeutics (NASDAQ: SRPT) has extended the options under the Research License and Option Agreement to license the rights to develop and commercialize Selecta’s immune tolerance platform, ImmTOR®, for use in Duchenne Muscular Dystrophy (DMD) and certain Limb-Girdle Muscular Dystrophies (LGMD).
Clinical Pipeline Updates
DISSOLVE II, the second of two Phase 3 clinical studies evaluating SEL-212 for chronic refractory gout, continues to progress. SEL-212 is a combination of Selecta’s ImmTOR® immune tolerance platform and a therapeutic uricase enzyme (pegadricase).
“As a result of Selecta’s proactive addition of 11 trial sites in
Swedish Orphan Biovitrum AB, (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. The completion of enrollment in DISSOLVE I & II will result in a
DISSOLVE clinical program
The DISSOLVE Phase 3 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. In DISSOLVE I, safety and efficacy will be evaluated in 112 patients at six months and will have a six-month extension to evaluate safety. DISSOLVE II will assess safety and efficacy in approximately 140 patients 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 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 Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s and its partners’ ability to conduct its and their clinical trials and preclinical studies, the timing or making of any regulatory filings, the potential treatment applications of product candidates utilizing the ImmTOR platform in areas such as gene therapy, gout and autoimmune disease, the ability of the Company and its partners where applicable to develop gene therapy products using ImmTOR, the novelty of treatment paradigms that the Company is able to develop, whether the observations made in non-human study subjects will translate to studies performed with human beings, the potential of any therapies developed by the Company to fulfill unmet medical needs, the Company’s plan to apply its ImmTOR technology platform to a range of biologics for rare and orphan genetic diseases, the potential of the Company’s technology to enable repeat administration in gene therapy product candidates and products, the ability to re-dose patients and the potential of ImmTOR to allow for re-dosing, the potential to safely re-dose AAV, the ability to restore transgene expression, the potential of the ImmTOR technology platform generally and the Company’s ability to grow its strategic partnerships, and enrollment in the Company's clinical trials. 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 proof of concept trials, including the 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 ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, 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, 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, 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, substantial fluctuation in the price of its common stock, risks related to geopolitical conflicts and pandemics and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and in other filings that the Company makes with the Securities and Exchange Commission All information in this press release is as of the date of the release, and
Source: Selecta Biosciences, Inc.