This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

Start Date30 Nov 2020

Sponsor / Collaborator

Swedish Orphan Biovitrum AB

NCT04513366

/ CompletedPhase 3

A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy was performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

Start Date18 Aug 2020

Sponsor / Collaborator

Swedish Orphan Biovitrum AB

NCT03905512

/ CompletedPhase 2

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.

Start Date07 May 2019

Sponsor / Collaborator

Selecta Biosciences, Inc.

100 Clinical Results associated with SEL-212

100 Translational Medicine associated with SEL-212

100 Patents (Medical) associated with SEL-212

Literatures (Medical) associated with SEL-212

02 Apr 2024·Rheumatology (Oxford, England)

The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout

Article

Author: DeHaan, Wesley ; Azeem, Rehan ; Kivitz, Alan J ; Traber, Peter G ; Choi, Hyon K ; Baraf, Herbert S B ; Strand, Vibeke ; Terkeltaub, Robert ; Keenan, Robert T ; Dalbeth, Nicola ; Khanna, Puja P

Abstract:

Objectives:

Serum urate (SU) lowering with PEGylated uricases in gout can reduce flares and tophi. However, treatment-emergent anti-drug antibodies adversely affect safety and efficacy and the currently approved PEGylated uricase pegloticase requires twice-monthly infusions. Investigational SEL-212 therapy aims to promote uricase-specific tolerance via monthly sequential infusions of a proprietary rapamycin-containing nanoparticle (ImmTOR) and pegadricase.

Methods:

COMPARE was a randomized, phase 2, open-label trial of SEL-212 vs pegloticase in adults with refractory gout. SEL-212 [ImmTOR (0.15 mg/kg) and pegadricase (0.2 mg/kg)] was infused monthly or pegloticase (8 mg) twice monthly for 6 months. The primary endpoint was the proportion of participants with SU <6 mg/dl for ≥80% of the time during 3 and 6 months. Secondary outcomes were mean SU, gout flares, number of tender and/or swollen joints and safety.

Results:

During months 3 and 6 combined, numerically more participants achieved and maintained a SU <6 mg/dl for ≥80% of the time with SEL-212 vs pegloticase (53.0% vs 46.0%, P = 0.181). The percentage reductions in SU levels were statistically greater during months 3 and 6 with SEL-212 vs pegloticase (−73.79% and −47.96%, P = 0.0161). Reductions in gout flare incidence and number of tender and/or swollen joints were comparable between treatments. There were numerical differences between the most common treatment-related adverse events of interest with SEL-212 and pegloticase: gout flares (60.2% vs 50.6%), infections (25.3% vs 18.4%) and infusion-related reactions (15.7% vs 11.5%), respectively. Stomatitis (and related terms) was experienced by eight participants (9.6%) with SEL-212 and none with pegloticase. Stomatitis, a known event for rapamycin, was associated with ImmTOR only.

Conclusions:

SEL-212 efficacy and tolerability were comparable to pegloticase in refractory gout. This was associated with a substantial reduction in treatment burden with SEL-212 due to decreased infusion frequency vs pegloticase.

Clinical trial registration:

NCT03905512.

01 Jan 2024·Journal of molecular graphics & modelling

Theoretical investigation of asphaltene molecules in crude oil viscoelasticity enhancement

Article

Author: Cui, Peng ; Yuan, Shideng ; Zhang, Heng ; Yuan, Shiling

Understanding the mechanisms of viscosity enhancement in crude oil phases is crucial for optimizing extraction and transportation processes. The enhanced viscosity mechanism of crude oil phase can be attributed to the intricate intermolecular interactions between asphaltene molecules. However, the molecular mechanism of the viscosification of asphaltene molecules in crude oil is not yet to be fully understood. In this work, molecular dynamics simulations were employed to investigate the dynamic behavior and viscosification mechanism of asphaltene molecules in complex oil phases. Research suggests that the neutral surface of asphaltenes features abundant positive and negative electrostatic potential regions, facilitating complementary pairing between these areas. This significantly augments electrostatic interactions among asphaltene molecules. Besides, the expansive nonpolar expanse on the normal asphaltene surface facilitates interactions between asphaltenes and crude oil molecules. This leads the crude oil viscosity of the system containing normal asphaltene is higher than that of the system containing acidic asphaltene under the same mass fraction (382 μ Pa·s for AAsp and 416 μ Pa·s for NAsp). This work provides insight into the viscosity enhancement mechanisms in crude oil phases and is helpful in improving the efficiency of crude oil extraction and transportation.

01 Aug 2023·Rheumatology and therapy

Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110)

Article

Author: Choi, Hyon ; Kishimoto, Takashi K ; Kivitz, Alan ; Rhodes, Sheri ; Leung, Sheldon S ; DeHaan, Wesley ; Johnston, Lloyd ; Traber, Peter G ; Azeem, Rehan ; Nicolaou, Savvas ; Park, Justin ; Inshaw, Jamie ; Sands, Earl

INTRODUCTION:

SEL-212 is a developmental treatment for uncontrolled gout characterized by serum uric acid (sUA) levels ≥ 6 mg/dl despite treatment. It comprises a novel PEGylated uricase (SEL-037; also called pegadricase) co-administered with tolerogenic nanoparticles containing sirolimus (rapamycin) (SEL-110; also called ImmTOR^®), which mitigates the formation of anti-drug antibodies (ADAs) against uricase and SEL-037 (PEGylated uricase), thereby enabling sustained sUA control (sUA < 6 mg/dl). The aim of this study was to identify appropriate dosing for SEL-037 and SEL-110 for use in phase 3 clinical trials.

METHODS:

This open-label phase 2 study was conducted in adults with symptomatic gout and sUA ≥ 6 mg/dl. Participants received five monthly infusions of SEL-037 (0.2 or 0.4 mg/kg) alone or in combination with three or five monthly infusions of SEL-110 (0.05-0.15 mg/kg). Safety, tolerability, sUA, ADAs, and tophi were monitored for 6 months.

RESULTS:

A total of 152 adults completed the study. SEL-037 alone resulted in rapid sUA reductions that were not sustained beyond 30 days in most participants due to ADA formation and loss of uricase activity. Levels of ADAs decreased with increasing doses of SEL-110 up to 0.1 mg/kg, with anti-uricase titers < 1080 correlating with sustained sUA control and reductions in tophi. Overall, 66% of evaluable participants achieved sUA control at week 20 following five monthly doses of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg, whereas only 26% achieved sUA control at week 20 when SEL-110 was withdrawn after week 12. Compared to other dose combinations, SEL-037 0.2 mg/kg + SEL-110 0.15 mg/kg achieved the greatest sUA control at week 12 and was well-tolerated with no safety concerns.

CONCLUSION:

Results provide continued support for the use of multiple monthly administrations of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg in clinical trials for SEL-212.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT02959918.

News (Medical) associated with SEL-212

18 Feb 2026

·www.prnewswire.com

Sobi Capital Markets Day 2026: Bringing brilliant ideas to life and building the next chapter with ambition to deliver SEK 55bn by 2030

STOCKHOLM, Feb. 18, 2026 /PRNewswire/ -- Sobi® (STO: SOBI) today hosts its Capital Markets Day, where senior management will provide an update on the company's strategy and outline its new mid-term outlook, aiming to achieve SEK 55bn revenue by 2030, while building a resilient platform for sustained growth beyond 2030. Sobi aims to have an adjusted EBITA margin in the upper 30s percentage of revenue by 2030. Sobi has delivered strong and profitable growth in recent years, transforming and diversifying its portfolio and positioning the company to deliver on six major launches. Additionally, Sobi is advancing priority development programs enabling longer term growth and continuing its international expansion. "Sobi today is a stronger, more global and more scientifically driven company," says Guido Oelkers, CEO of Sobi. "We have delivered on our commitments, built a diversified, robust foundation for future growth, and are entering the next phase of expansion with multiple launches and compelling opportunities to unlock growth well beyond 2030." Highlights of the Capital Markets Day Sobi shares its ambition to reach SEK 55bn in revenues by 2030, effectively doubling the company revenue driven by six major launches, continued strong performance of strategic products, and international expansion. Sobi outlines major launches either ongoing or in preparation, expected to drive the majority of growth to 2030, including Altuvoct®, Gamifant®, Aspaveli®, Tryngolza®, NASP, and pozdeutinurad, across haematology, immunology, and specialty care. Deep dives demonstrate Sobi's scientific leadership in: Uncontrolled and progressive gout and two potentially transformative treatment innovations in an area of high unmet patient needs. Severe hypertriglyceridemia, where acute pancreatitis is a major risk and a severe medical emergency, and ApoC-III inhibition with olezarsen has shown significant and meaningful reductions in acute pancreatitis risk. Precision medicine in sepsis: In biomarker-selected patients with interferon gamma-driven sepsis (the proof-of-concept EMBRACE study), Sobi will share topline data for empalumab demonstrating improvement in SOFA-based organ function (achieving primary endpoint at end of treatment in 60% patients receiving high dose emapalumab vs 40% in the standard of care plus placebo arm). High dose emapalumab additionally showed a 12-percentage point absolute mortality reduction after 28-days (40% mortality in the high dose emapalumab arm vs 52% in the standard of care plus placebo arm). Additional information provided New peak sales expectations for the following products: Haemophilia A franchise (Altuvoct and Elocta) greater than SEK 10bn, Aspaveli between SEK 7-10bn, Gamifant in HLH between SEK 5-7bn, NASP between SEK 4-6bn, Tryngolza greater than SEK 10bn, pozdeutinurad greater than SEK 10bn and Gamifant in IDS greater than SEK 10bn. R&D expenses to remain between 11-14 per cent of sales on a given year between now and 2030. Agenda in brief The Capital Markets Day includes presentations from Sobi's executive leadership on strategy, pipeline and innovation, commercial opportunities and financial outlook as well as disease deep dives with experts and leaders in their respective fields, and a concluding Q&A session. Pre-registration for online attendance: click here A recording of the presentations and supporting materials will be made available on . Sobi Sobi® is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2025 revenue amounted to SEK 28 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:00 CET on 18 February 2026. Gerard Tobin Head of Investor Relations This information was brought to you by Cision The following files are available for download: SOURCE Swedish Orphan Biovitrum AB 21% more press release views with Request a Demo

Clinical Result

15 Dec 2025

·firstwordpharma.com

Sobi snaps up Arthrosi in $1.5B deal to deepen gout franchise

Swedish Orphan Biovitrum (Sobi) on Saturday announced it will acquire Arthrosi Therapeutics in a deal potentially worth up to $1.5 billion — gaining rights to the latter’s investigational once-daily oral URAT1 inhibitor in late-stage development for gout.The buyout adds pozdeutinurad (AR882) to Sobi’s gout franchise, which already includes Selecta Biosciences-partnered nanoencapsulated sirolimus plus pegadricase (formerly SEL-212) currently under FDA review for uncontrolled gout. Pozdeutinurad is currently being explored in two global Phase III trials — REDUCE 1 and REDUCE 2 — evaluating serum uric acid lowering, alongside tophi and flare reductions in patients with progressive and tophaceous gout; pivotal readouts for both studies are due next year."The acquisition…allows us to expand our gout pipeline with a highly differentiated new asset," remarked Guido Oelkers, chief executive officer of Sobi, adding that "pozdeutinurad has the potential to become the therapy of choice for patients…with persistent and unresolved symptoms despite first-line therapy."Under terms of the deal expected to close in the first half of next year, Sobi will pay Arthrosi $950 million upfront in cash, with an additional $550 million contingent upon achieving clinical, regulatory and sales milestones.In October, Arthrosi wrapped up a $153-million series E to pursue clinical development of pozdeutinurad. ApicHope holds rights to the drug in the Greater China region.

AcquisitionPhase 3Drug Approval

15 Dec 2025

·endpoints.news

Sobi to buy gout biotech Arthrosi for $950M upfront

Sobi plans to buy Arthrosi Therapeutics, a Phase 3 gout biotech, for $950 million upfront and as much as $550 million in additional milestones, the Swedish drugmaker said Saturday. The Arthrosi acquisition arrives just two months after the seven-year-old biotech disclosed a $153 million Series E to complete two late-stage tests of pozdeutinurad, its experimental URAT1 inhibitor. At the time, Arthrosi said it expected the trials to read out in the second quarter of 2026. After a bleak few years, the biopharma industry has been enjoying a surge in M&A over the past few quarters, including deals for Bluejay , Halda and Cidara announced in recent weeks. With the deal, Sobi will buy into a brewing competition in the URAT1 space. Sobi CEO Guido Oelkers said the drug “has the potential to materially accelerate our growth until the mid 2030s, and beyond.” The URAT1 field heated up this fall, with Arthrosi’s raise and another megaround from fellow San Diego biotech Crystalys Therapeutics. Crystalys unveiled with a $205 million Series A and two Phase 3 trials of dotinurad, which is approved in Japan, China and a few other countries in Asia. Both companies are working on URAT1 medicines that, in people with gout, aim to tamp down on serum urate levels. Urate crystals can form in joints, especially the big toe, when too much uric acid builds up in the blood. Patients experience intense pain and inflammation. “We believe that Sobi’s global expertise in commercialisation will accelerate our shared mission to deliver pozdeutinurad’s potentially transformative benefits for individuals living with gout,” Arthrosi CEO and founder Litain Yeh said in a statement. Also for gout, Sobi has a drug before the FDA with a June 27 action date. That drug is called nanoecapsulated sirolimus plus pegadricase (NASP), formerly known as SEL-212 . Sobi anticipates the Arthrosi deal will close in the first half of 2026.

AcquisitionPhase 3Drug ApprovalPhase 2

100 Deals associated with SEL-212

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic tophaceous gout	NDA/BLA	United States	Swedish Orphan Biovitrum AB	02 Jul 2024
Gout	Phase 3	United States	Selecta Biosciences, Inc.	-
Arthritis, Gouty	Phase 2	United States	Selecta Biosciences, Inc.	07 May 2019
Hyperuricemia	Phase 2	United States	Selecta Biosciences, Inc.	01 Oct 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04596540 (DISSOLVE II, CTgov)	Phase 3	Chronic tophaceous gout	153	Placebo	dsacykvsna = mjtpgpuhio mpwrpzuyvr (anzvuwbebz, wpgzehbijy - rcyemzjeqq) View more	-	03 Dec 2025
NCT04513366 (DISSOLVE I, ACR2025)	Phase 3	Gout	229	NASP (high-dose)	hidzpmosad(bqdlsjgcru) = vwyynzbpux ktoiwizriy (kiouqodlhe ) View more	Positive	24 Oct 2025
				NASP (low-dose)	hidzpmosad(bqdlsjgcru) = nfvhrpromr ktoiwizriy (kiouqodlhe ) View more
NCT04513366 (DISSOLVE I, CTgov)	Phase 3	Chronic tophaceous gout	112	normal saline	uwkfwiqmod = ulfqqfdnkt vyzsswkaqt (wnlmdiqjcz, hhheoukvog - ptbokfcdat) View more	-	11 Sep 2025
NCT04513366 (DISSOLVE I, ACR2024)	Phase 3	Chronic tophaceous gout	265	SEL-212 High-Dose (US)	gkgnngttct(jjsfqdzqxj) = lzvrbrsesb nyoihpyggc (fyccwmaupv )	Positive	10 Nov 2024
				SEL-212 Low-Dose (US)	gkgnngttct(jjsfqdzqxj) = imumpuxxjy nyoihpyggc (fyccwmaupv )
NCT04596540 \| NCT04513366 (DISSOLVE II, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Gout	265	SEL-212 0.15 mg/kg (high-dose)	pcrprluazt(wnqgkfileg) = pvwbvxblnt vqdcigjzjx (fispmntprh, 9.5) View more	Positive	14 Jun 2024
				SEL-212 0.1 mg/kg (low-dose)	pcrprluazt(wnqgkfileg) = qczpsygvui vqdcigjzjx (fispmntprh, 9.4) View more
NCT04513366 (DISSOLVE I, EULAR2024)	Phase 3	Gout	38	SEL-110 at 0.15 mg/kg + SEL-037 at 0.2 mg/kg	kvsftgzdve(grvzwtjlfq) = The most common adverse event of special interest across all three treatment arms was gout flare imhvgkazxd (igmwqxlqqv ) View more	Positive	05 Jun 2024
				SEL-110 at 0.1 mg/kg + SEL-037 at 0.2 mg/kg
NCT03905512 (COMPARE, CTgov)	Phase 2	Gout \| Chronic tophaceous gout \| Arthritis, Gouty	170	SEL-212 (SEL-212)	inkymbtxrw = ovvuivbnea suzkalnhlp (apvmdwhohk, ginoiqvejw - mgjfqvefeq) View more	-	17 Oct 2023
				KRYSTEXXA® (KRYSTEXXA)	inkymbtxrw = ojpfyxurrb suzkalnhlp (apvmdwhohk, mwlotkwagy - wknzhtllep) View more
NCT03905512 (COMPARE, Corporate Publications) Manual	Phase 2	Chronic tophaceous gout	170	SEL-212	uuhvkolwao(efhypmrhop) = lwrgsficax xcwuiigedt (eypmsisvuj ) View more	Positive	30 Sep 2020
				Pegloticase	uuhvkolwao(efhypmrhop) = njpoibfxyo xcwuiigedt (eypmsisvuj ) View more
NCT02959918 (ACR2019) Manual	Phase 2	Gout	152	SEL-212	jnpdibfllb(yrimlljemk) = kqwqkfwxgx feurhsiodv (dlboasdvmg ) View more	Positive	11 Nov 2019
				Pegadricase	-
SEL-212 (EULAR2019)	Phase 2	Gout	152	SEL-212 (0.1 mg/kg ImmTOR + 0.2 mg/kg pegadricase)	didwhrakpu(kovjyxjbwx) = All evaluable patients receiving 0.1 or 0.15 mg/kg ImmTOR administered with 0.2 mg/kg pegadricase who achieved three months of SUA control maintained SUA control in months four and five of combination treatment asgkvmkirf (gkjylrvclx ) View more	-	12 Jun 2019
				SEL-212 (0.15 mg/kg ImmTOR + 0.2 mg/kg pegadricase)

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