Date: 2015-08-03
Type of information: Results
phase: 1
Announcement: results
Company: Protalix BioTherapeutics (Israel)
Product: PRX-106 (biosimilar version of etanercept)
Action
mechanism: fusion protein/biosimilar
Disease: immune mediated disorders
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details: The Phase I trial is a randomized, parallel-design, open-label study designed to evaluate the safety and pharmacokinetics of PRX-106 in healthy volunteers. The trial enrolled 14 subjects that were randomized to one of three dosing cohorts receiving PRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects received once daily oral administrations for 5 consecutive days.
Latest
news: * On August 3, 2015, Protalix BioTherapeutics announced positive clinical study results from the Company's Phase I trial of PRX-106, an orally administered plant cell-expressed recombinant anti-TNF fusion protein. PRX-106 demonstrated a favorable safety and tolerability profile and biological activity in the gut. The trial enrolled 14 subjects that were randomized to one of three dosing cohorts receiving PRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects received once daily oral administrations for 5 consecutive days. The results demonstrated that oral administration of PRX-106 is safe and well tolerated. No major side effects were noted, and no suppression of the immune system was observed. Regulatory T cell activation showing biological activity in the gut was observed. Fluorescence-activated cell sorting analysis (FACS) was performed using various antibodies for surface markers, and it was observed that all three dosages of PRX-106 promoted the induction of various subsets of T cells, some of which are correlated with anti-inflammatory response. In preclinical studies evaluating oral PRX-106 the compound alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A immune mediated hepatitis mouse model. Additionally, oral administration of PRX-106 alleviated immune mediated colitis in a well-established mouse model, promoting serum levels of anti-inflammatory IL-10 and regulatory T-cells. Protalix is currently evaluating the best indication to take forward with PRX-106. The Company anticipates identifying this shortly and initiating a proof of concept trial in patients around year end. * On June 20, 2013, Protalix BioTherapeutics has held an Analyst Event in which included the disclosure of new data regarding new compounds in development. One of this compound, oral PRX-106 for immune mediated disorders, is the Company's proprietary plant cell recombinant Anti-TNF fusion protein being developed as an orally-administered treatment for immune mediated disorders.
In preclinical studies, oral PRX-106 alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A (ConA) mouse model. Additionally, oral administration of PRX-106 alleviated immune mediated colitis, a well established model for Crohn's disease, promoting serum levels of anti-inflammatory IL-10 and regulatory T-cells. The Company is conducting additional preclinical studies for oral PRX-106 in additional attractive indications.
