RedHill gets added backwind for drug to treat Crohn’s disease

Israeli biopharmaceutical firm is also awaiting results of critical study on its drug to combat H. pylory, the bacteria that can cause peptic ulcer and gastric cancer

Shoshanna Solomon was The Times of Israel's Startups and Business reporter

Illustrative. (Bet_Noire; iStock by Getty Images)
Illustrative. (Bet_Noire; iStock by Getty Images)

RedHill Biopharma Ltd., an Israeli biopharmaceutical firm that focuses on gastrointestinal diseases, has presented additional clinical data regarding a late stage clinical trial of what is potentially a “groundbreaking” drug to treat Crohn’s disease, a severe inflammatory disease of the gastrointestinal tract that affects millions and has no known cure.

The study has shown that approximately 40 percent of patients taking the drug, together with other standard medication, have gone into remission at week 26.

The potentially groundbreaking orally administered drug, called RB-104, combines three kinds of antibiotics, and is based on the hypothesis that Crohn’s disease is caused by a bacterial infection called the mycobacterium avium subspecies paratuberculosis (MAP) bacteria, which has been found in patients suffering from Crohn’s.

The latest results were presented at the United European Gastroenterology Week (UEG Week 2018) by Dr. David Graham, Professor of Medicine, Molecular Virology and Microbiology at Baylor College of Medicine, Houston, who was the lead investigator of the study.

Dror Ben-Asher, the CEO of RedHill Biopharma Ltd. (Courtesy)

The new data presented at the conference “showed that patients receiving RHB-104 on-top of other approved therapies did better than those on placebo, regardless of the therapy they were receiving, and demonstrated the potential broad benefit of RHB-104 as add-on therapy to standard-of-care in Crohn’s disease,” said Dror Ben-Asher, the CEO of Redhill in a phone interview.

Results of the Phase III clinical study were presented first in July, indicating that the MAP US study, as it is called, met its main and secondary targets, demonstrating the “superiority of RHB-104 over a placebo in achieving remission at week 26,” the company said in a statement at the time.

“Continued analysis of data collected during the MAP US study has further bolstered” the positive results in Crohn’s disease initially reported a few months ago, Dr Ira Kalfus, RedHill’s medical director, said in a statement released by Redhill on Monday, after the presentation of the latest data. The “presentation demonstrates RHB-104’s potential as a therapy that can improve the outcomes seen with the current standard-of-care treatments across a broad spectrum of Crohn’s disease patients.”

Crohn’s disease can lead to abdominal pain, severe diarrhea, fatigue, and weight loss. The ailment’s prevalence among Jews is among the highest in the world. The company acquired the drug combination from an Australian company run by Professor Thomas Borody, who was using three antibiotics that are used to treat patients with leprosy and tuberculosis.

“These are very important results because for the first time a big international study with hundreds of patients has shown that a drug that is targeting an infection” has attained “strong efficacy” results in driving a high percentage of Crohn patients into remission, Ben-Asher said.

He added that company officials plan to meet with the FDA “in early 2019 to discuss the development plan towards approval and the next clinical study” that he expects will be needed, “given the groundbreaking treatment” the company proposes.

Indeed, he explained, unlike current standard of care treatments for the disease, that deal the symptoms of Crohn’s and not the disease, RHB-104 aims to treat the disease itself, by tackling bacteria that the researchers believe could be at the root of the illness.

The number of diagnosed prevalent Crohn’s disease cases worldwide is estimated to reach over 1.59 million in 2018, with sales of Crohn’s disease therapies estimated to exceed $10 billion, according to data compiled by GlobalData.

Awaiting study results of another potentially revolutionary drug

RedHill was founded by Ben-Asher and Ori Shilo, two kibbutz dwellers turned investment bankers and now entrepreneurs, who named their company after a soothing earth-red hill that overlooks their Givat Brenner Kibbutz.

RedHill’s RHB-105 drug for H.pylori (Courtesy)

The company is also expecting to get by year-end the results of a late-stage clinical study for an additional drug, TALICIA or RHB-105, for the eradication of Helicobacter pylori, the bacterial infection that has been proven to cause peptic ulcer disease and gastric cancer, Ben-Asher said.

“This is a confirmatory Phase III study which follows the first successful study with TALICIA which demonstrated 89.4% eradication rate,” he said. “To put this in context, current standard-of-care therapies are estimated to have efficacy rates of only 70%,” because the bacteria are growing increasingly resistant to the antibiotics used in the standard of care therapies, he said.

“The results from the confirmatory Phase III study are expected by the end of this year and we are very excited towards this major milestone. If the results are positive, we could file for marketing approval early next year, and potentially gain approval by the second half of 2019,” he said, adding that the drug has the potential to become a “blockbuster” selling medication.

“Given that more than half of the world’s population is estimated to be infected, and given that it is causing most of the gastric cancer cases – (there are an) estimated 1 million death cases a year from gastric cancer alone — and stomach ulcer cases, as well as other diseases, H. pylori is an infection that is a major public health concern and is listed very high on the priority list” of the US government, the World Health Organization and governments, he said.

The company, whose shares are traded on the Nasdaq and in Tel Aviv, has a market capitalization of some $210 million, and some $43 million in cash, without debt, that will enable it to complete its trials, Ben-Asher said. The firm may also look for a strategic partner for the Crohn drug, he said.

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