A March 14 H.C. Wainwright & Co. research note indicated that Protalix Biotherapeutics Inc. (PLX:NYSE) released topline data from its Phase 2 study of OPRX-106 in ulcerative colitis, and according to analyst Ram Selvaraju, those data were "positive."
In this randomized, open-label trial, 24 patients with active mild to moderate ulcerative colitis received either 2 or 8 milligrams of OPRX-106 once daily for eight weeks, Selvaraju explained. OPRX-106 is Protalix's oral anti-tumor necrosis factor (anti-TNF) therapeutic. Eighteen patients completed the study.
A Mayo score was used to evaluate how the patients responded. The average Mayo score at the start of the study for those who finished it was 7.1. Of those 18 participants, 89% originally had a Mayo score between 6 and 9, a range that denotes moderate disease activity.
The analyst highlighted that "the key efficacy endpoints of the study were met," which correlates with the previously reported findings from the interim data analysis. After the eight weeks of treatment, 67% percent of patients achieved a clinical response. This was indicated by drop in the Mayo score of three or more points plus either a rectal bleeding subscore of 0 or 1 or a one point decrease in it.
Also after the eight weeks, 28% of patients experienced a clinical remission. Their final Mayo score was 0, 1 or 2 and their subscores no greater than 1.
Selvaraju concluded, "The positive trend in efficacy was consistent in substantially all patients." Specifically, 89% of patients showed an improvement in Mayo score, with an average three-point or 45% decrease. In other words, their score dropped to 4.1 at the end of the eight weeks from 7.1 at the outset. Further, most patients showed improvement in one or more of the other efficacy measures.
They included improved rectal bleeding scores and improved rectal calprotectin; 72% of patients experienced both of those. A third was an improved Geboes score, a commonly used index for ulcerative colitis; 61% of patients showed that.
The study data also revealed that OPRX-106 was safe and well tolerated, with only mild to moderate, short-duration adverse events, most commonly headache. Antibodies against OPRX-106 were not seen.
The anti-TNF market, into which OPRX-106 would fall, could be as sizable as $30 billion, the analyst noted. This estimate is based on total sales of Humira (adalimumab) and Enbrel (etanercept).
H.C. Wainwright has a Buy rating and $5 per share target price on Protalix, whose stock is currently trading at around $0.60 per share. The target price does not assume any contribution from OPRX-106, Selvaraju pointed out. "Therefore, the data from this recently reported study may position this program as a substantial value driver going forward."
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Disclosures from H.C. Wainwright & Co., Protalix BioTherapeutics Inc., Company Update, March 14, 2018
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Protalix BioTherapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of February 28, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Protalix BioTherapeutics, Inc.
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The Firm or its affiliates did not receive compensation from Protalix BioTherapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in Protalix BioTherapeutics, Inc. as of the date of this research report.