Immune Pharmaceuticals Announces FDA Acceptance of Investigational New Drug (IND) Application in the U.S. for Bertilimumab for the Treatment of Bullous Pemphigoid
Nov 9, 2015
NEW YORK, Nov. 9, 2015 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune" or the "Company") announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) application for its first in class, lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP). This FDA acceptance enables the Company to expand recruitment for its clinical trials.
Immune's IND application is for the treatment of BP, an orphan autoimmune skin disease known to be associated with increased eotaxin-1 levels in serum and blister fluids. The U.S./EU BP patient population is estimated at 60,000 patients and is expected to grow to 90,000 patients by 2025. Most diagnosed patients are elderly, and BP, along with other conditions, impacts daily life extensively.
"An autoimmune blistering disease, Bullous Pemphigoid, has no real treatments beyond powerful anti-inflammatory medicines called corticosteroids. Yet, for patients with suppressed immune systems, steroids may not be a long-term treatment option. We believe that regulating eotaxin-1 levels may provide patients with much needed relief," said Neil Korman, MD, PhD, Professor of Dermatology, University Hospitals, Case Medical Center, Cleveland, OH.
Immune recently initiated a Phase IIa open label clinical trial in BP in Israel at the Tel Aviv University School of Medicine. This trial is designed to recruit 10-15 patients diagnosed with moderate to severe BP in order to evaluate symptomatic improvement and reduction in the use of steroids. Immune now has the opportunity to treat BP patients in clinical trials conducted in the U.S. in three planned centers, including Mt. Sinai School of Medicine in New York under the direction of Annette Czernik, MD, Clinical Director of Dermatology.
"The IND acceptance enables Immune to include leading U.S. academic medical centers in our clinical trial program. We are ready to expand our trials in the U.S., and in Europe, subject to regulatory acceptance there. Access to a larger number of centers also allows the Company to receive feedback on Bertilimumab from key opinion leaders and we believe may allow accelerated patient recruitment," stated Dr. Daniel Teper, CEO of Immune Pharmaceuticals.
"Bullous Pemphigoid patients are generally elderly, and they suffer from blistering and often severe pain, itching, burning and stinging. This chronic illness needs treatments, and we are gratified that Immune is committed to advancing clinical understanding developing a treatment," said William J. Zrnchik II, M.B.A., M.N.M., Chief Executive Officer, International Pemphigus & Pemphigoid Foundation.
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.
For further information: Christine J. Petraglia, Director Investor Relations, Immune Pharmaceuticals, (646) 440-9332, Christine.Petraglia@immunepharma.com; Media Inquiries: Kristie Kuhl, Finn Partners, (212) 583-2791, firstname.lastname@example.org