RedHill Biopharma Ltd. (Nasdaq: RDHL); (TASE: RDHL) today reported positive results in its trial of a product for treatment of Crohn's Disease. RedHill said that after 26 weeks of treatment with its product, 27% of the sample patients went into remission from the disease, compared with 23% of the control group. The p-value for the test was 0.013. The company's share price responded by surging and is now up 67% in preliminary trading on Nasdaq.
The trial was conducted on 325 patients, a fairly small sample for a Phase III trial. A statistically significant result is more impressive with a small sample. At the same time, another trial is needed after a small trial because the effect of a small number of patients with an exceptional result is greater in a small trial. The company must therefore conduct a Phase III confirmatory study before submitting its product for marketing approval. RedHill said today, as it has in the past, that it would try to find a partner to continue the development process so that it would not have to finance the trial by itself. RedHill had $36 million in cash as of the end of the first quarter of 2018. The company has an open shelf prospectus.
The trial also met a number of secondary targets. Remission among patients was achieved sooner and more patients from the treatment group were in remission during the entire treatment year. These two differences were also significant. After 52 weeks of treatment, the number of patients in remission was still higher in the treatment group than in the control group but the results were not significant (a p-value of 0.155). The product was in the range for use.
RedHill will continue to assess the trial results and will publish additional figures in the coming months.
The product for treatment of Crohn's Disease is RedHill's leading product, but the company also has another important product - an improved antibiotic for treatment of H. pylori, which is in confirmatory Phase III trials scheduled for completion in last 2018.
RedHill's CEO is Dror Ben-Asher.
Published by Globes [online], Israel business news - www.globes-online.com - on July 30, 2018
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