Protalix Biotherapeutics Inc (NYSE:PLX) stock is riding a nearly 10% gain this morning after the Israeli biotech firm unleashed positive interim data from its Phase II clinical study in ulcerative colitis (UC). The trial is investigating the company’s oral anti-TNF drug OPRX-106, with data set loose from the first 14 patients who have completed the randomized, open label, two-arm study. Results look positive regarding OPRX-106’s efficacy and impact on treating active mild to moderate UC.
A total of 24 patients were enrolled and randomized to receive 2 mg or 8 mg of OPRX-106, administered orally, once daily, for 8 weeks. The first 14 patients have completed the study, and four patients are currently in treatment and follow-up. The trial evaluated key efficacy endpoints including clinical response and remission utilizing the Mayo score, as well as safety and pharmacokinetics.
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Data generated from the first 14 patients who completed the study demonstrates that 57% of the patients achieved clinical response and 36% achieved clinical remission at week 8.
In the rectal bleeding analysis, a sub category of the Mayo score, 79% of those patients show an improvement.
In addition, the majority of those patients show improvement in the study’s additional efficacy endpoints, with 86% of the patients achieved an improvement in calprotectin, a protein biomarker present in the feces indicating intestinal inflammation, and 64% have an improved Geboes score, a histopathological scoring for the assessment of disease activity in ulcerative colitis.
Clinical response at week 8 is defined as a decrease in the Mayo score of at least 3 points and either a decrease in the sub-score for rectal bleeding of at least 1 point from baseline, or rectal bleeding sub-score of 0 or 1. Clinical remission at week 8 is defined as clinically symptom free, a Mayo score ≤ 2, with no individual sub-score exceeding 1 point after treatment.
Treatment was well tolerated and the majority of adverse events have been mild to moderate and transient in nature, with headaches being the most common.
“These initial efficacy results for OPRX-106 are very impressive as they represent clear clinical benefits,” said Professor Yaron Ilan, Chairman of the Department of Medicine, and an expert in Gastroenterology, at The Hadassah Hebrew University Medical Center in Jerusalem. “Orally administered OPRX-106 is a tremendous step forward with the potential benefit of significantly lower side effects as it does not suppress the immune system while redirecting it in an anti-inflammatory direction, as opposed to the currently approved anti-TNF treatments, all of which are administered via injection or infusion, and carry potential short and long term side effects.”
OPRX-106 is the Company’s novel proprietary plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc). When administered orally and while passing through the digestive tract, the plant cells function as a natural delivery capsule, having the unique attribute of a cellulose cell wall, which makes them resistant to degradation compared to proteins produced via mammalian cell expression systems.
“We are very excited by these first-in-patient results, which demonstrate that novel, orally administered, OPRX-106 treatment is biologically active in the gut with clear clinical effect,” said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer.
The Company expects to report full results from this study by the end of the first quarter of 2018.
Recently, the Company has successfully expressed a plant cell based anti TNF alfa protein comparable to adalimumab (Humira®) for oral administration.
PLX has a 1-year high of $1.51 and a 1-year low of $0.38. The stock’s 50-day moving average is $0.66 and its 200-day moving average is $0.67.
On the ratings front, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on PLX, with a price target of $5, in a report issued on November 29. The current price target represents a potential upside of 658% from where the stock is currently trading.
According to TipRanks.com, Selvaraju has a yearly average loss of 16.7%, a 28% success rate, and is ranked #4675 out of 4727 analysts.
Protalix Biotherapeutics, Inc. engages in the development and commercialization of recombinant therapeutic proteins based on ProCellEx plant cell based expression system. It offers Taliglucerase alfa injections under the brand name Elelyso, an enzyme replacement therapy for Gaucher disease. The company’s drug also include Oral Glucocerebrosidase for potential treatment of Gaucher disease; therapeutic proteins for Fabry disease, and immune diseases such as rheumatoid, psoriatic and juvenile idiopathic arthritis, ankylosing, spondylitis, and plaque psoriasis; and protein for biodefense and other indications.