(Información remitida por la empresa firmante)
–Response rate of 56% in patients treated monthly with high dose SEL-212 in DISSOLVE I and 47% in DISSOLVE II
–In patients 50 years and older, response rate with high dose SEL-212 was 65% in DISSOLVE I and 48% in DISSOLVE II
–75% of subjects in the DISSOLVE I extension phase on active treatment were responders through 12 months of therapy with no infusion reactions or new safety signals
–Favorable safety profile with 3.4% of patients with infusion reactions at high dose
WATERTOWN, Mass. and STOCKHOLM, March 21, 2023 /PRNewswire/ — Selecta Biosciences, Inc. (NASDAQ: SELB) and Sobi®, today announced positive topline results from the Phase 3 DISSOLVE I & II placebo controlled randomized clinical trials to determine safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout. The DISSOLVE I (the “US Study”) met its primary endpoint, with 56% of patients receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response (defined as achievement and maintenance of reduction in serum urate (SU) 6mg/dL for at least 80% of the time during month six). The DISSOLVE II (the “Global Study”) also met its primary endpoint, with 47% receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).
Herbert S. B. Baraf, MD, FACP, MACR, Clinical Professor of Medicine, George Washington University School of Medicine and Health Sciences; Principal Investigator of the DISSOLVE Program said, “Based on these data, I believe SEL-212 has the potential to provide an important new uricase-based treatment option for patients with chronic refractory gout. These patients suffer from chronic pain and endure debilitating functional impairment. The demonstrated profound lowering of the serum uric acid in the DISSOLVE program should meaningfully impact the quality of the lives of these severely afflicted patients. SEL-212’s favorable safety profile, coupled with the convenient once monthly treatment regimen, will be welcomed by patients with this challenging form of gout and the physicians who treat them.”
Topline results from the Phase 3 DISSOLVE program are as follows:
DISSOLVE I had a statistically significant higher response rate of SEL-212 during month six: 56% and 48% of patients randomized to receive SEL-212 at the high dose of 0.15 mg/kg (p0.0001) and the low dose of 0.1 mg/kg (p0.0001) of ImmTOR, respectively, versus 4% of patients randomized to receive the placebo reached the primary endpoint
DISSOLVE II also had a statistically significant higher response rate of SEL-212 during month six: 47% and 41% of patients randomized to receive SEL-212 at high dose (p=0.0002) and low dose (p=0.0015) of ImmTOR, respectively, versus 12% of patients randomized to receive the placebo reached the primary endpoint
Statistically significant higher response rate in patients 50 years and older at the high dose in DISSOLVE I and II: 65% and 47% of DISSOLVE I patients randomized to receive SEL-212 at the high dose (p0.0001) and the low dose (p0.0001) of ImmTOR, respectively, versus 5% of patients randomized to receive the placebo reached the primary endpoint; 48% and 45% of DISSOLVE II patients randomized to receive SEL-212 the high dose (p=0.0017) and low dose (p=0.0044) of ImmTOR, respectively, versus 14% of patients randomized to receive the placebo reached the primary endpoint
Significant and clinically meaningful overall reduction of 69% in mean SU levels in patients randomized to receive SEL-212 at 0.15mg/kg in DISSOLVE I, as compared with placebo: Serum urate levels were reduced by an average of 5.3 mg/dL (computed by subtracting baseline SU from mean SU during the treatment period 6) for patients treated with both doses of SEL-212 (p0.001) compared to 0.3 mg/dL increase in patients receiving placebo
SEL–212was observed to have a favorable safety profile and was well-tolerated across both doses of ImmTOR: The adverse events (AEs) identified in the trials were expected, including mild to moderate stomatitis which was seen in 3.4% of the low dose group and 9.2% of the high dose group versus 0% in placebo and a greater number of infusion reactions at 24 hours and 1 hour after drug administration in both treatment groups versus placebo. Treatment-related serious AEs were observed in six patients, including two cases of anaphylaxis and one gout flare in both the high and low dose treatment groups. Only 4.5% of patients receiving the low dose of SEL-212 and 3.4% at the high dose of SEL-212 had infusion reactions, evaluated 1 h post dose. All infusion reactions occurred within the first three infusions, and each occurred during infusions and completely resolved with infusion halt and symptomatic treatment. There was one death in the six-month extension phase of the trial, which was caused by a motor vehicle accident unrelated to the study drug. There was no difference in gout flares when both treatment groups were compared to placebo.
The six-month extension period in the DISSOLVE I trial, showed that the majority (75%) of patients who completed 6 months of SEL-212 treatment as a responder, continued to be successfully treated through 12 months with no infusion reactions or safety signals.
Peter Traber, M.D., Chief Medical Officer of Selecta, said, “We are very pleased by the robust response rate in the high dose group of SEL-212, especially across older patients (=50 years) and the observed durability of response with no infusion reactions or new safety signals through the extension period. We believe the results of SEL-212 observed in these two Phase 3 trials suggest the potential to provide a new treatment solution with convenient once monthly dosing.”
Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta, commented, “The positive readout of the DISSOLVE program is a pivotal milestone for SEL-212, a novel once-monthly treatment option, and for the many patients suffering from chronic refractory gout. We believe the strong efficacy and favorable safety data observed across both doses of ImmTOR in this program positions ImmTOR as the only immune tolerance platform with positive Phase 3 data. We have dosed over 400 patients to date, and plan to continue to leverage our growing safety database to drive forward our clinical pipeline powered by our ImmTOR technology.”
Guido Oelkers, Ph.D., President and Chief Executive Officer of Sobi, added, “We are thrilled with the positive results of the DISSOLVE program and the potential to bring this new treatment option to improve the lives of patients with chronic refractory gout. We are poised to move SEL-212 forward towards commercialization and intend to file marketing authorization applications in the U.S. in the first half of 2024.”
Anders Ullman, M.D., Ph.D., Head of Research & Development and Medical Affairs, Chief Medical Officer of Sobi, commented, “Altogether, the DISSOLVE program data instils confidence in SEL-212, and we look forward to further exploring its therapeutic potential as we drive forward development on a potential commercial path forward. We remain committed to bringing our therapies to the global patient community as quickly as possible.”
Detailed results from the DISSOLVE I and DISSOLVE II trials are expected to be presented at an upcoming medical meeting. Regulatory submission in the U.S. is anticipated in the first half of 2024.
(CONTINUA)