Significant effect! Serious gout new drug announced excellent 2 data

Significant effect! Serious gout new drug announced excellent 2 data

June 19, 2018 Source: WuXi PharmaTech

Recently, Selecta Biosciences announced its ongoing expansion of phase 2 clinical trials of SEL-212 at the European Union of European Rheumatology (EULAR) Annual European Rheumatology Congress in 2018. In this study, patients received 0.15 mg/kg SVP-rapamycin and 0.2 or 0.4 mg/kg pegiticase for the treatment of chronic severe gout.

A subgroup of gout patients experience chronic severe gout, usually manifested as a high burden of tophi (inflammatory nodules of crystalline uric acid) and does not respond to existing drugs. Patients with chronic severe gout experience recurrent and highly debilitating attacks, gouty arthritis, and a significant reduction in quality of life. They urgently need effective drugs to alleviate the disease and alleviate the pain.

SEL-212 is a monthly treatment protocol developed by Selecta, co-administered by SVP-rapamycin and pegiticase to prevent anti-drug antibodies (ADAs). There are clinical data available to show that this candidate product has the ability to significantly reduce serum uric acid to facilitate rapid dissolution of the tophi, and to reduce seizures and other symptoms.

This expanded data is based on data recently published on PANLAR, which received a 3-month dose of SEL-212 (up to 0.15 mg/kg SVP-rapamycin and 0.2 or 0.4 mg/kg pegiticase), followed by A two month dose of pegiticase was received alone. The results showed that at week 12, approximately 81% of evaluable patients (n = 27) had serum uric acid below 6 mg/dl. In another FDA-approved uric acidase study, 44% of evaluable patients had serum uric acid below 6 mg/dl at week 16. 33% of the EULAR data represented the patient population, and 27% of patients who received SEL-212 in the Phase 2 study experienced gout flares during the first month after treatment and gout attacks during the second to fifth months keep falling. This reduction is much lower than the rate of gout attacks reported in clinical trials involving current FDA-approved uricases. In addition, the study also showed that patients were well tolerated by SEL-212.

â–² Dr. Werner Cautreels, President and CEO of Selecta (Source: Selecta Biosciences official website)

“We are very pleased with the ongoing improvement in clinical activity observed in this extended patient dataset published on EULAR and believe it further demonstrates the potential of SEL-212 to change the treatment paradigm of chronic severe gout. Compared to providing better and longer-lasting serum uric acid control, reducing the frequency of seizures and dosing," said Dr. Werner Cautreels, President and CEO of Selecta, "We are now in the 5 month dose of SEL-212 combination therapy. The fourth treatment cycle, and plans to report data on these patients at the upcoming medical conference in the third quarter of this year. These data have the potential to demonstrate the extended benefits of SEL-212 in patients with chronic severe gout with high medical needs and We are able to conduct the 3 phases of the study we plan to launch later this year."

Reference materials:

[1] Selecta Unveils Expanded Positive Clinical Data for its Gout Treatment

[2] Selecta Biosciences Presents Data from Ongoing Phase 2 Trial of SEL-212, in Development for Chronic Severe Gout, at EULAR 2018

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