WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of four abstracts that highlights data from its immunology portfolio at the ACR Convergence 2024 taking place in Washington, D.C. from November 14-19, 2024.
Sobi's commitment to delivering innovative treatments for people living with immunological diseases is seen in global studies spanning multiple disorders:
- Results from two Phase 3 trials evaluating the effect on patient-reported outcomes in patients with chronic refractory gout treated with SEL-212.
- Initial data on the effect of anti-drug antibodies on serum uric acid (sUA) reduction and safety in response to treatment with SEL-212.
- DISSOLVE 1 Phase 3 study: Results of a post hoc analysis of sustained sUA reduction and safety of SEL-212 in patients with chronic refractory gout living in the United States.
- Results from a Phase 3 Study and a pooled analysis of two prospective trials evaluating efficacy and safety of emapalumab in patients with Macrophage Activation Syndrome in Still's disease.
| Chronic Refractory Gout | ||
| SEL-212 | Improvements in Patient-Reported Outcomes After Treatment with SEL-212 in Adults with Refractory Gout: Results from Two Randomized Phase 3 Trials | Session: Patient Outcomes, Preferences, & Attitudes Poster I Saturday, November 16; 10:30 AM - 12:30 PM |
| Impact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional Therapy
Safety and Efficacy of SEL-212 in the US and ex-US Subgroups: Results from the Phase 3 DISSOLVE Studies | Session: Metabolic & Crystal Arthropathies - Basic & Clinical Science Poster III
Monday, November 18; 10:30 AM - 12:30 PM | |
| Macrophage Activation Syndrome | ||
| Emapalumab | Efficacy and Safety of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's disease: Results from a Phase 3 Study and a Pooled Analysis of Two Prospective Trials
| Late-Breaking Abstracts November 19; Session Time: 8:00 AM - 9:30 AM; Presentation Time: 9:00 AM - 9:15 AM |
All abstracts can be accessed via the official ACR Convergence website.
Contacts
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About SEL-212
SEL-212 is being developed as a novel once-monthly combination medicine that integrates targeted immunomodulation with uricase-based therapy and is being investigated for the treatment of chronic refractory gout . SEL-212 consists of pegadricase, a proprietary pegylated uricase, co-administered with nanoencapsulated sirolimus.
About 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 refractory gout (CRG), where patients are resistant to conventional medicines and symptoms are more persistent. CRG is a painful and debilitating condition in people with persistent raised serum uric acid (sUA) levels, which may result in several flares per year and the development of nodular masses of uric acid crystals known as tophi.
About emapalumab-lzsg
Emapalumab-lzsg is a fully human, anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. In the US, emapalumab-lzsg is indicated for pediatric (newborn and older) and adult primary hemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab-lzsg is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval in 2018 was based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).For the treatment of HLH, Emapalumab is indicated for administration through twice per week until hematopoietic stem cell transplantation (HSCT). The efficacy and safety of emapalumab are currently being evaluated. Emapalumab is currently under investigation (phase 3) in patients with MAS in Still's disease or systemic lupus erythematosus (SLE) (EMERALD; NCT05001737).
U.S. Indication for Gamifant® (emapalumab-lzsg)
Gamifant® (emapalumab-lzsg) is an interferon gamma (IFNγ)-blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy.
Important Safety Information
Infections
Before initiating Gamifant, patients should be evaluated for infection, including latent tuberculosis (TB). Prophylaxis for TB should be administered to patients who are at risk for TB or known to have a positive purified protein derivative (PPD) test result or positive IFNγ release assay.
During Gamifant treatment, patients should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated.
Patients should be administered prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to Gamifant administration.
Increased Risk of Infection With Use of Live Vaccines
Do not administer live or live attenuated vaccines to patients receiving Gamifant and for at least 4 weeks after the last dose of Gamifant. The safety of immunization with live vaccines during or following Gamifant therapy has not been studied.
Infusion-Related Reactions
Infusion-related reactions, including drug eruption, pyrexia, rash, erythema, and hyperhidrosis, were reported with Gamifant treatment in 27% of patients. In one-third of these patients, the infusion-related reaction occurred during the first infusion.
Adverse Reactions
In the pivotal trial, the most commonly reported adverse reactions (≥10%) for Gamifant included infection (56%), hypertension (41%), infusion-related reactions (27%), pyrexia (24%), hypokalemia (15%), constipation (15%), rash (12%), abdominal pain (12%), CMV infection (12%), diarrhea (12%), lymphocytosis (12%), cough (12%), irritability (12%), tachycardia (12%), and tachypnea (12%).
Additional selected adverse reactions (all grades) that were reported in less than 10% of patients treated with Gamifant included vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema.
Please see the full Prescribing Information for Gamifant.
About Sobi North America
As the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi's vision of being a leader in providing innovative treatments that transform lives for individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and specialty care. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at https://www.sobi.com/usa or at www.sobi.com.
About Sobi®
Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube.
Brian Castelli
brian.castelli@sobi.com