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CDX-6512 is an engineered gastrointestinal-stable methionine-gamma-lyase enzyme being developed by Codexis as a potential orally administered therapy for homocystinuria. The biologic is designed to resist gastric acidity and upper intestinal proteases so it can remain active in the gastrointestinal tract and degrade dietary methionine released from protein digestion before that methionine is absorbed and converted into homocysteine. By lowering the methionine substrate load, CDX-6512 aims to reduce toxic homocysteine accumulation in patients with homocystinuria. Preclinical studies reported serum homocysteine suppression of up to about 45% in animal models, and the program had received FDA orphan drug designation and rare pediatric disease designation while remaining in pre-IND development.
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