Immune Pharmaceuticals Reports Encouraging Preliminary Data with Bertilimumab in an Open Label Phase 2 Study in the Rare Dermatological Auto-Immune Disease, Bullous Pemphigoid
Broadens Eligibility Criteria to Include Steroid Tapering Resistant Patients
Company Files for Orphan Drug Designation
Feb 28, 2017
NEW YORK, Feb. 28, 2017 /PRNewswire/ -- Immune Pharmaceuticals Inc. (Nasdaq: IMNP) ("Immune" or the "Company") today announced that it has broadened enrollment eligibility criteria based on the data reported from three patients that have completed treatment to date in its ten-patient open label study of Bertilimumab in the treatment of Bullous Pemphigoid ("BP"). In those patients, the Bullous Pemphigoid Disease Activity Index ("BPDAI") was reduced by an average of 84% and oral prednisone was tapered down to 10mg or less. No significant adverse events were reported. Based on these preliminary results, the Company has also submitted a request for orphan drug designation for Bertilimumab in BP. BP is a rare autoimmune blistering disease of the skin, which is painful and itchy, and occurs predominantly in patients more than 60 years of age.
The study has been initially focused on patients who have been recently diagnosed with BP. Investigators involved in the study have voiced a desire to permit entry of patients who are not newly diagnosed, but are having difficulty being tapered off of chronic steroids, so-called taper resistant patients. As is often the case in rare diseases, there is little prior information to guide study design, and we believe that early studies such as this one have the potential to inform future efforts. The initial data in the ongoing study support the ability to now include such taper resistant patients, and test whether the ability to taper would improve when treated with the study drug, Bertilimumab.
"BP patients suffer extremely uncomfortable symptoms and must be treated. High dose steroids help control the symptoms, however they expose patients of any age, and particularly older populations, to significant medical risks. Dermatologists have limited treatment options other than steroids at this time. Bertilimumab may offer new hope for patients," said Neil Korman, MD, Professor of Dermatology, Case Western University, Cleveland, Ohio. "The early data from the study's subjects have been very encouraging in terms of safety, control of symptoms measured by the BPDAI, a clinically validated disease index, and tapering of steroids to 10 mg daily or less. The ability to now include BP patients who have previously been diagnosed but cannot be successfully tapered off of steroids together with newly diagnosed patients, will provide further insight into which BP patients might potentially benefit from this treatment, and better inform the design of a future study in this disease."
Immune continues to support the associated patient group, the International Bullous Pemphigus and Pemphigoid Foundation ("IPPF"). "The promise of a therapy directed towards patients with BP is very exciting, and we are eagerly anticipating further information on Immune's progress with Bertilimumab," said Mark Yale, the Executive Director of the IPPF.
"It is particularly gratifying to share this news on Rare Disease Day and bring hope to patients with BP. We are pleased that we filed an Orphan Drug Designation application for Bertilimumab in BP." commented Immune Chief Medical Officer, Monica Luchi, MD. "We believe that personalized therapies have the potential to help provide an optimized safety-to-efficacy ratio by selecting patients with higher response rates based on specific biomarkers. We look forward to evaluating the opportunities for Bertilimumab moving ahead in BP and other immuno-inflammatory diseases including Severe Atopic Dermatitis."
Bertilimumab targets eotaxin-1, a specific chemokine that plays a role in both innate and adaptive immune responses and modulates the cross-talk between key cells involved in inflammation. Bertilimumab is a first-in-class monoclonal antibody that blocks eotaxin-1 and is designed for targeted therapy in inflammatory conditions mediated by high eotaxin-1 levels, among which are Severe Atopic Dermatitis, Crohn's Disease and Ulcerative Colitis, Non-Alcoholic Steato-Hepatitis ("NASH"), and severe eosinophilic asthma. A phase 2 study in patients with ulcerative colitis is ongoing, and a study in patients with severe atopic dermatitis is planned.
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. 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 Phase II clinical development for moderate-to-severe ulcerative colitis as well as for BP, an orphan autoimmune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and NASH, an 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 oncology pipeline includes Ceplene®, which is in late stage clinical development for maintenance remission in Acute Myeloid Leukemia in combination with IL-2. Additional oncology pipeline includes Azixa® and crolibulin, Phase II clinical stage vascular disrupting agents, and novel technology platforms; bispecific antibodies and NanomAbs™. Maxim Pharmaceuticals Inc., Immune's pain and neurology subsidiary is developing AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharma.com, the content of which is not a part of this press release.
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. Examples of forward-looking statements contained in this press release include, among others, statements regarding our interpretation of preliminary clinical trial results, assessment of positive nature and notability of preliminary data, development plans for our product candidate, the ability to complete clinical trials, the safety, potential efficacy and therapeutic potential of our product candidate, quotes from management regarding the expectations for our industry and our business, and our application for Orphan Drug Designation.
Forward-looking 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. The preliminary results described in this press release are based on observations of a limited number of patients and may not be predictive of the results that would be observed among a larger patient population. In addition, these preliminary results may not be predictive of results to be obtained in the additional evaluations and studies that would be necessary to demonstrate the effectiveness of Bertilimumab. Full analysis of the existing and future data may not support any or all of the statements in this press release. Full analysis of the existing and future data, if any, may not support any or all of the statements in this press release. We cannot assure you that we will have sufficient working capital to complete such trials, or that the outcome of any such trials will support our efforts to commercialize Bertilimumab. Other factors that may cause actual results or developments to differ materially from those in this press release 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, Ceplene, Azixa, AmiKet, AmiKet Nano, LidoPain or NanoCyclo 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.immunepharma.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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