3SBio & Selecta To Develop Non-Immunogenic Gout Drug

By combining pegsiticase with Selecta’s synthetic vaccine particle platform, 3SBio hopes to develop an anti-gout drug that will not be affected by drug resistance.

AsianScientist (Jun 27, 2014) – 3SBio Inc., a China-based biotechnology company, has entered into an exclusive license with Selecta Biosciences for pegsiticase (Uricase PEG-20), a treatment for gout.

Phase I clinical test showed that pegsiticase is able to efficiently reduce plasma uric acid levels in gout patients. The exclusive license enables Selecta to develop pegsiticase in patients with refractory and tophaceous gout and apply its immunomodulatory synthetic vaccine particle (SVP) platform to optimize the safety and efficacy profile for patients at risk of immunogenicity. SEL-212 is a novel product that combines Selecta’s proprietary SVP with 3SBio’s pegsiticase and is designed to be the first non-immunogenic version of uricase.

“Patients with refractory and tophaceous gout have currently very limited treatment options. Indeed, these patients generally cannot be successfully treated by conventional oral gout drugs,” said Dr. Jing Lou, CEO of 3SBio.

A painful inflammatory disease caused by elevated plasma uric acid levels, gout affects more than ten million patients worldwide. Chronic refractory gout represents approximately two percent of patients, who cannot be effectively treated with available oral therapies. Tophaceous gout is a debilitating condition resulting from painful deposits of uric acid crystals in joints, tendons and surrounding tissue that affects seven to ten percent of gout patients.

Oral therapies are not indicated because their mechanism of action interferes with the synthesis of uric acid but is ineffective in the breakdown of existing uric acid deposits. Approved uricase enzymes are highly effective for a short course of treatment, but can rapidly lose efficacy due to the formation of anti-drug antibodies. Their clinical use is further restricted due to high risks of allergic reactions.

“Pegsiticase has already shown significant efficacy signals in gout patients and we have the opportunity to develop a novel therapeutic approach with the goal of preventing the inhibitory antibodies and other complications of immunogenicity that have been a significant barrier to the widespread use of uricase-based drugs. With the combination of SVP and pegsiticase, we believe we can dramatically improve treatment for patients with refractory and tophaceous gout,” said Dr. Werner Cautreels, President and CEO of Selecta.

“Working with 3SBio, we have the potential to fulfill a key medical need expressed by physicians—the first non-immunogenic uricase. 3SBio’s strength of enzyme manufacturing combined with Selecta’s proprietary antigen-specific tolerance platform will ensure fast progress towards human proof of concept. If successful, Selecta’s SVP platform may unlock the full therapeutic potential of many other biologic therapies adversely affected by immunogenicity.”

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Source: 3SBio.
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