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Selecta Biosciences stock flies after it kicks off head-to-head clinical trial of SEL-212 versus Krystexxa in chronic refractory gout patients

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Selecta Biosciences Inc (NASDAQ:SELB) rocketed Monday after it kicked off a six-month clinical trial ubiquitously titled COMPARE, to prove the superiority of its drug SEL-212 to the US Food and Drug Administration-approved Krytexxa treatment for patients suffering chronic refractory gout.

Selecta’s SEL-212 lead candidate in Phase 2, is being developed to treat severe gout and resolve debilitating symptoms, which include flares and gouty arthritis. Clearly, SEL-212 will compete head-to-head with Savient Pharmaceutical’s Krytexxa, which is administered intravenously.

Shares in Selecta Biosciences shot up 14.8% to 2.71 before the opening bell.

Potential to meet several unmet medical needs​

SEL-212 is being developed as a monthly treatment consisting of pegadricase, a potent uric acid-lowering enzyme, co-administered with SVP-Rapamycin to prevent anti-drug antibodies. Selecta has generated clinical data indicating SEL-212 can lower serum uric acid to levels conducive to a rapid reduction of painful flares.

“We are excited about the opportunity to demonstrate the superiority of SEL-212 compared to the current FDA-approved uricase therapy, as we continue to believe that our product candidate has the potential to fulfill several unmet needs in chronic refractory gout patients, including sustained serum uric acid reduction, reduced painful flares and once monthly dosing,” said Selecta Biosciences CEO Dr Carsten Brunn.  

The CEO said the Watertown, Massachusetts-based clinical-stage biopharmaceutical company, will report interim six-month data in the fourth quarter of 2019.

READ: CytoDyn to share data on flagship drug leronlimab at the American Association of Cancer Research

On a separate note, the company also strengthened its management and clinical development teams with the appointments of Elona Kogan as general counsel and corporate secretary, and Horacio Plotkin as head of clinical development. 

“This is a pivotal time for the company as we kick off the COMPARE trial with the aim of making significant therapeutic advances in chronic refractory gout and continue advancing Selecta’s promising ImmTOR gene therapy platform,” said Kogan.

The COMPARE trial is expected to enrol between 100 and 150 patients and is designed to compare the potential and safety of SEL-212 to Krystexxa in adults with chronic refractory gout.

The primary endpoint is expected to be the maintenance of serum uric acid levels of <6mg>

The results of the COMPARE trial are expected to inspire the design of the planned Phase 3 clinical trial of SEL-212, which the company plans to initiate in the fourth quarter of 2019.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter@UttaraProactive 

Story by ProactiveInvestors


Source: https://www.proactiveinvestors.com/companies/news/217657/selecta-biosciences-stock-flies-after-it-kicks-off-head-to-head-clinical-trial-of-sel-212-versus-krystexxa-in-chronic-refractory-gout-patients-217657.html


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