Protalix BioTherapeutics Announces Positive Results from Phase II Clinical Trial of OPRX-106 for the Treatment of Ulcerative Colitis
Clinical Responses Observed in 67% of Patients and Clinical Remission Observed in 28% of Patients
No Anti-Drug Antibodies Detected
CARMIEL,
The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106. A total of 24 patients with active mild to moderate ulcerative colitis were enrolled in the study. Patients were randomized to receive 2 mg or 8 mg of OPRX-106, administered orally, once daily, for 8 weeks. The average base line Mayo score was 7.1 for the 18 patients who completed the study with 89% of those patients having a Mayo score of between 6 and 9, which meets the criteria of moderate disease activity.
The key efficacy endpoints of the study were met:
- 67% of patients experienced a clinical response; and
- 28% of patients experienced a clinical remission.
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.
In addition, other key efficacy endpoints were also achieved:
- 72% of patients showed an improvement in rectal bleeding scores;
- 72% of patients demonstrated an improvement in fecal calprotectin; and
- 61% of patients showed improved Geboes score (a histopathological scoring for the assessment of disease activity in ulcerative colitis).
The positive trend in efficacy was consistent in substantially all patients. This trend is demonstrated by 89% of the patients having showed an improvement in Mayo score, with an average decrease in Mayo score of 45%, or 3 points, or from 7.1 at baseline to 4.1, at week 8. In addition, the vast majority of patients also showed an improvement in at least one of the other efficacy parameters.
No anti-drug antibodies were detected. OPRX-106 was safe and well tolerated with only mild to moderate adverse events, which were transient in nature. Headaches were the most common adverse event reported.
“We are very excited by these results,” commented
“The data is very encouraging, suggesting that OPRX-106 could potentially address a large unmet medical need in the treatment of ulcerative colitis. OPRX-106 is delivered orally and is biologically active in the gut without triggering the formation of anti-drug antibodies. OPRX-106 has the potential to address the partial loss of response seen in anti-TNF alpha treatment, which is driven by the high presence of neutralizing antibodies,” said Professor
The Company intends to release full results at a medical conference later in the year.
About
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (
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Investor Contact
Marcy Nanus
Solebury Trout Group
646-378-2927
mnanus@troutgroup.com
Source: Protalix BioTherapeutics, Inc.