Protalix Pharmaceuticals announces positive results in phase 2 trial treating patients with Ulcerative colitis.
Protalix BioTherapeutics Announces Positive Data For Phase 2 Ulcerative Colitis Trial
: On Monday, Protalix BioTherapeutics (PLX) announced positive results in patients with ulcerative colitis. These results stemmed from the company's phase 2 trial which recruited a total of 24 patients. The positive data was from 14 evaluable patients as an interim analysis. One thing to note is that this trial was done using clinical measures, and not a comparison to a placebo. Still, the results were quite impressive. Patients were either given 2 mg or 8 mg of OPRX-106 orally once daily over an 8-week treatment period. It was observed that out of the 14 patients who finished the study, 57% achieved a complete response. At least 36% achieved clinical remission of ulcerative colitis. Clinical remission being when symptoms are no longer present. In addition, there was a high score using the Mayo score for rectal bleeding. At least 79% of participants showed an improvement in this metric.
Analysis: The results were good despite not having a placebo in the study. It was still shown that OPRX-106 was effective in patients with ulcerative colitis. Why I believe the stock didn't close higher is because of a few reasons. For starters, 14 patients is a small sample size. It could be possible that investors were looking for a larger patient population. Secondly, the results are an interim look. It appears as though investors want to wait to see all the data before coming to any final conclusions. What I like about the results is that not only was it good but it was all achieved by using an oral version of OPRX-106 (anti-TNF drug). That's because other current standard of care therapies require patients to be injected or infused with treatment. Being able to give patients an oral drug compared to an injection is a huge advantage. It provides for better patient compliance. Not only that, but the current treatment options have more side effects because they affect the immune system. I would be inclined to say that affecting the immune system is not ideal as a side effect. OPRX-106 on the other hand has fewer side effects compared to current standard therapies. Protalix expects to release the full data set later in this quarter. If the results hold up then it will have a good drug on its hands, with the potential for blockbuster status. Protalix BioTherapeutics remains a good buy because it is highly undervalued with a market cap of only $96 million.
