PROTALIX BIOTHERAPEUTICS, INC. (PLX)

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Protalix BioTherapeutics Announces First Patient Dosed in First in Human Phase I Clinical Trial of PRX-115 for the Treatment of Severe Gout

https://finance.yahoo.com/news/protalix-biotherapeutics-announces-first-patient-105000063.html

PRX-115 is a PEGylated recombinant uricase produced from the proprietary ProCellEx® platform as a potential treatment of severe gout

CARMIEL, Israel, March 21, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that the first patient has been dosed in the Company's phase I First in Human (FIH) clinical trial of PRX-115, the Company's recombinant PEGylated uricase product candidate under development as a potential treatment of severe gout.

The phase I FIH trial is a double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, pharmacodynamics (reduction of uric acid) and immunogenicity of PRX-115 in patients with elevated uric acid levels (>6.0 mg/dL). The trial is a single ascending dose (SAD) study with up to seven cohorts, and patients are to be randomized 3:1 to receive a single intravenous (IV) dose of PRX-115 or a placebo. The study is being conducted at New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines, and is expected to enroll approximately 56 patients with no previous exposure to PEGylated uricase.

"We are pleased to initiate this first in human trial of PRX-115," said Dror Bashan, Protalix's President and Chief Executive Officer. "This milestone highlights our commitment to building and strengthening our pipeline. Given our corporate mission to deliver new medicines to patients with high, unmet needs, we look forward to continued enrollment and dosing of patients in this trial."