Protalix Biotherapeutics Inc (NYSEAMERICAN: PLX) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced overwhelmingly positive interim data from a key clinical trial. Today, we’ll talk about the data that was released, what we’re seeing from the stock as a result, and what we’ll be watching for with regard to PLX ahead.
PLX Announces Positive Data
As mentioned above, Protalix BioTherpeutics is having an overwhelmingly strong start to the trading session in the pre-market hours after announcing solid interim clinical data. The data that was released came from the first 14 patients that completed the Phase 2 clinical trial of OPRX-106 to date. OPRX-106 is designed for the treatment of patients with ulcerative colitis.
The clinical trial is a 2-arm study OPRX-106 in patients with active mild-to-moderate ulcerative colitis. 24 patients have been enrolled in the trial and randomized to receive either 2 mg or 8 mg of OPRX-106 administered orally on a once daily basis for 8 weeks.
According to the press release issued by the company, the first 14 patients have completed the study. Also, PLX said that 4 patients are currently in treatment and follow up. During the trial, PLX is evaluating key efficacy endpoints including clinical response and remission. This is based on what’s known as the Mayo score. The company is also assessing safety and pharmacokinetics associated with the treatment.
In the press release issued this morning, Protalix announced that the first 14 patients that have completed the study generated data demonstrating that 57% of patients achieved a clinical response and 36% of patients achieved clinical remission at week 8.
Also, PLX said that the majority of the patients have shown improvement in the study’s additional efficacy endpoints. In fact, 86% of patients achieved an improvement in calprotectin and 64% showed an improved Geboes score, a score designed for the assessment of disease activity in ulcerative colitis. In astatement, Professor Yaron Ilan, Chairman of the Department of Medicine, and an expert in Gastroenterology at The Hadassah Hebrew University Medical Center in Jerusalem, had the following to offer with regard to the PLX study:
“These initial efficacy results for OPRX-106 are very impressive as they represent clear clinical benefits… 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.”
How The Stock Reacted To The News
As investors, one of the first things that we learn is that the news moves the market. So, with overwhelmingly strong results from a key clinical trial, it’s no surprise that we’re seeing strong gains out of Protalix Biotherapeutics this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:26), PLX is trading at $0.725 per share after a gain of $0.064 per share (9.65%) thus far this morning.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on PLX. In particular, we’re interested in following the ongoing development of OPRX-106, and we’re excited to see the treatment move forward through the development phase. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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