Immune Pharmaceuticals Reports Encouraging Preliminary Data with Bertilimumab in an Open Label Phase 2 Study in the Rare Dermatological Auto-Immune Disease, Bullous Pemphigoid
- Category: Antibodies
- Published on Thursday, 02 March 2017 11:47
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NEW YORK, NY, USA I February 28, 2017 I 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.
SOURCE: Immune Pharmaceuticals