Immune Pharmaceuticals Announces Enrollment of the First Patient into the Phase 2 Clinical Trial with Bertilimumab in Ulcerative Colitis
Phase 2 Clinical Trials Expanding to U.S. and Europe
Nov 17, 2015
NEW YORK, Nov. 17, 2015 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune" or the "Company") announced today that the first patient has been enrolled into the Phase 2 clinical trial evaluating the safety and efficacy of its first in class fully human monoclonal antibody, bertilimumab in Ulcerative Colitis (UC).
"We recently announced U.S. IND acceptance by the FDA for bertilimumab in bullous pemphigoid, and today, with our first patient enrollment in ulcerative colitis, this represents an important development for our lead product, bertilimumab. We intend to include leading academic medical centers globally, to support the timely completion of our two Phase 2 clinical trials," said Dr. Daniel Teper, CEO of Immune.
This double blind placebo-controlled randomized Phase 2 clinical trial is planned to enroll 42 patients, with moderate to severe UC. Eligible patients will be randomly assigned in a 2:1 ratio to one of two treatment groups, bertilimumab 10 mg/kg or matching placebo, respectively. Patients will receive three IV infusions over 30 minutes, at two-week intervals and will be evaluated for safety as well as efficacy measured by a reduction in the Mayo Clinic Ulcerative Colitis Disease Index at week 8.
Secondary end points include assessment of mucosal injury and clinical remission. Patients will be selected based on Mayo score and high levels of tissue eotaxin-1, as well as other standardized clinical criteria.
Brian Feagan, M.D., Professor of Medicine, University of Western Ontario, CEO of Robarts Research Institute stated, "We expect this trial to be an important proof of concept study in moderate to severe UC patients with elevated eotaxin-1. In addition to the Mayo Clinic Score of Disease activity, we expect the quantitative measurement of mucosal injury by centrally read endoscopy will provide an objective initial assessment of bertilimumab efficacy."
To date, in previously conducted Phase 1 single dose clinical trials, bertilimumab demonstrated initial safety and tolerability as well as dose dependent biological activity.
A Vanderbilt study, supported by a grant from the National Institute of Health (NIH), and published in PlosOne (PLoS One. 2013 Dec 18;8(12)) showed a positive correlation (p=0.006, r=0.318) between tissue eotaxin-1 levels and disease activity index in UC patients. The authors concluded that their data implicates eotaxin-1 in the etiology of UC, and that eotaxin-1 measurement may be useful to select patients for therapy with bertilimumab.
Eran Goldin, M.D., Chairman, Digestive Disease Institute and Head of Gastroenterology at Shaare Zedek Medical Center in Jerusalem, Israel, commented, "It is really exciting for me as a clinical researcher in Inflammatory Bowel Disease, that for the first time, a patient from Israel with active UC has received a new treatment, bertilimumab, within the frame of a Phase 2 clinical trial. Bertilimumab is a new and, I believe, promising biological medicine, targeting eotaxin-1 and is known to have potent anti-inflammatory effects in UC and other diseases. In research that we conducted at our institute, eotaxin-1 was shown to be elevated in over 50% of patients with moderate to severe UC or Crohn's disease. Additionally, we demonstrated in animal studies that neutralizing eotaxin-1 leads to a reduction in the symptoms of ulcerative colitis."
About Immune Pharmaceuticals
Immune Pharmaceuticals applies a personalized approach to treating and developing novel, highly-targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, bertilimumab, is in clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan auto-immune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and NASH (inflammatory liver disease). Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated Cyclosporine A for the treatment of psoriasis and atopic dermatitis. Immune's pipeline also includes NanomAbs®, antibody nano-conjugates, for the targeted delivery of chemotherapeutics. Immune's non-core pipeline includes AmiKet™, a late clinical stage drug candidate for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharmaceuticals.com
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal" or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include, but not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that clinical trials for Bertilimumab or AmiKet will not be successful; the risk that Bertilimumab, AmiKet or compounds arising from our NanomAbs program will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet on attractive terms, on a timely basis or at all; the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger- scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings, which are available at www.sec.gov or at www.immunepharmaceuticals.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Immune Pharmaceuticals, Inc.
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