Results from six subjects demonstrate a large and statistically significant reduction in bullous pemphigoid activity despite aggressive prednisone tapering, with no serious adverse events.
September 27, 2017 08:00 AM Eastern Daylight Time
ENGLEWOOD CLIFFS, N.J.–(BUSINESS WIRE)–Immune Pharmaceuticals, Inc. (NASDAQ:IMNP) a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, today announced preliminary results from the first six subjects enrolled in its ongoing, open-label phase 2 study of bertilimumab in patients with moderate to severe bullous pemphigoid (BP) (study NCT02226146). In February 2017, the company reported results from the first three subjects enrolled in the study. The results from three new subjects confirm and extend previous findings.
The six subjects in the study experienced a decline in the Bullous Pemphigoid Disease Area Index (BPDAI) Total Activity Score of 85% (p=0.0096). The mean BPDAI Total Activity Score declined from a baseline of 56 to 10 by the final assessment on day 84 (except for one subject enrolled under the original protocol who had a final assessment on day 56). The improvement experienced by all six subjects was rapid, with a mean decline in the BPDAI Total Activity Score of 72% achieved by day 42 (p=0.0145). All six subjects in the study achieved a greater than 50% reduction in their BPDAI Total Activity Score by the final assessment, and four of the six patients had a greater than 90% reduction. Bertilimumab was well tolerated in all six subjects and no serious adverse events were reported.
An important goal of this study is to minimize steroid exposure, which causes significant morbidity and mortality in BP patients. Treatment guidelines for moderate-to-severe BP suggest a starting prednisone dose of 0.5-1.0 mg/kg and a slow taper. In contrast, all six subjects in the study experienced rapid improvement in their condition despite a low initial steroid dose and rapid taper. The mean initial prednisone dose was 0.3 mg/kg (equivalent to 26 mg), which was tapered to just 0.1 mg/kg (p=0.0014) by the last assessment. As of the last follow-up, five of the six subjects were receiving a prednisone dose of 10 mg or less.
The attached figure illustrates the mean BPDAI scores and mean prednisone dose observed in the study, as well as the prednisone dose that subjects would have received under the treatment regimen employed by Joly et al in their landmark study of oral and topical corticosteroids (Joly et al, New Engl J Med 2002; 347:143-145). Based on baseline disease severity, subjects in our ongoing phase 2 study would have been expected to be treated with an initial prednisone dose of 0.75 mg/kg (equivalent to a mean dose of 62 mg), tapering by day 84 to 0.4 mg/kg (equivalent to a mean dose of 27 mg). These subjects received approximately 30 mg per day less prednisone over the course of the study than they would have been expected to receive in a standard BP treatment regimen. A reduction in corticosteroid use to this extent would represent a meaningful step forward in the management of this challenging condition.
Dr. Neil Korman, Professor of Dermatology at the Case Western Reserve University School of Medicine, and Chair of Immune’s Scientific Advisory Board, stated “These results are quite impressive. Moderate-to-severe bullous pemphigoid is typically managed with 60 mg of prednisone and a very slow taper over several months. The improvement seen in these subjects despite such a low prednisone dose and a rapid taper strongly suggests bertilimumab is providing a clinically meaningful benefit. If bertilimumab can substantially reduce or perhaps even eliminate the need for systemic corticosteroids in the treatment of bullous pemphigoid and their significant toxicity in this elderly population, it will be a major step forward in the management of what is the most common blistering disease.”
Elliot Maza, President and Chief Executive Officer of Immune Pharmaceuticals, stated, “These promising preliminary results support our strategy of focusing our human capital and financial resources on our bertilimumab and NanoCyclo product candidates while streamlining our operations by divesting our unrelated oncology business. We will continue to enroll subjects into this phase 2 open label BP trial, which has a target enrollment of 12 to 15 patients, as we initiate plans for a larger clinical trial designed to prove that bertilimumab provides a significant benefit to patients suffering from this severe inflammatory disease.”
About Immune Pharmaceuticals
Immune Pharmaceuticals is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Our lead program, bertilimumab, is a first-in-class, humanized monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation. By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, thus helping to relieve associated inflammatory conditions. Currently, we are conducting two phase 2 clinical trials to test bertilimumab in patients suffering from bullous pemphigoid and ulcerative colitis, respectively. Bertilimumab may have application in other diseases, including NASH, atopic dermatitis, immune and inflammatory hepatitis, and asthma.
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The statements in this news release made by representatives of Immune Pharmaceuticals, Inc. relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Immune’s product candidates and the sufficiency of Immune’s cash and other capital resources, the continued development by Immune of bertilimumab or its determination to seek Orphan Drug designation for the pharmaceutical product of bertilimumab are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Immune’s ability to fund such efforts with or without partners. Immune undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Immune’s filings with the Securities and Exchange Commission, including those discussed in Immune’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and periodic reports filed on Form 8-K.
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