Akari Therapeutics Announces Publication of Phase II Data of Investigational Nomacopan for the Treatment of Bullous Pemphigoid (BP) in JAMA Dermatology
NEW YORK and LONDON, May 10, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, plc (Nasdaq: AKTX), a late-stage biotechnology company focused on development of advanced therapies for autoimmune and inflammatory diseases, announced positive results from the Phase II study of investigational nomacopan in bullous pemphigoid (BP) were published online in the Journal of the American Medical Association (JAMA) Dermatology. https://jamanetwork.com/journals/jamadermatology/article-abstract/2791461
“These positive Phase II data advanced our understanding of the nomacopan safety profile and informed duration of treatment in the ARREST-BP Phase III clinical trial, which is open for enrollment now,” said Rachelle Jacques, President and CEO of Akari Therapeutics.
BP is the most common autoimmune blistering skin disease. It typically affects people over the age of 65.1 There are no approved therapies but superpotent topical steroids and high dose oral corticosteroids (OCS) are the current standard of care. The mortality rate in BP is ~three-fold higher than the general population due to the disease itself, and infections and cardiovascular conditions that are more common in older patients and are exacerbated by treatment with high dose OCS.2 There is significant unmet need for an effective steroid-sparing therapy.
The goal of the Phase II study was to examine the safety and therapeutic potential of bispecific recombinant nomacopan, an inhibitor of both leukotriene B4 (LTB4) and complement C5, in patients with BP. The Phase II trial was a multicenter, single-group, nonrandomized controlled study conducted in the dermatology departments of hospitals in the Netherlands and Germany. Participants were enrolled between September 2018 and April 2020. Adult patients (aged >18 years) with mild to moderate, new-onset or relapsing BP were recruited into the study. Patients received nomacopan, 90 mg, subcutaneously on day one and 30 mg subcutaneously once daily until day 42.
The primary end point was the proportion of patients with Common Terminology Criteria for Adverse Events (CTCAE) grade three (severe AE), grade four (life-threatening or disabling AE), and grade five (death related to AE) adverse events associated, or possibly associated with nomacopan. Secondary end points included mean absolute and percentage changes in the Bullous Pemphigoid Disease Area Index (BPDAI) activity score, the BPDAI pruritus score, and the patient-reported outcome measures Dermatology Life Quality Index (DLQI) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL). The BPDAIactivity score provides an objective measure of disease extent by assessing blisters and urticarial/erythematous lesions affecting particular regions of the body surface and mucous membranes.3
A total of nine BP patients with a median age of 75 and a range of 55-85 years were included in the trial. There were no serious adverse events or CTCAE grade 3, 4 or 5 associated or possibly associated with nomacopan during the trial. The mean (90% CI) BPDAI activity score decreased from 32.0 (8.7) points on day one to 19.6 (9.0) points on day 42. Seven of nine patients (77.8%) responded to nomacopan with a reduction in the BPDAI activity score of at least eight points between day one and 42; where the minimum clinically important difference (MCID) in BPDAI activity is four.4 In three responders, the reduction in BPDAI was 80% or greater. On day 42, the mean (90% CI) BPDAI pruritus score had decreased by 6.8 (4.6) points from 17.6 (4.0) points on day one. The mean (90% CI) DLQI score decreased from 11.3 (4.2) points at baseline to 6.4 (3.8) points by day 42, and the mean (90% CI) TABQOL score decreased from 14.6 (5.4) points at baseline to 10.3 (5.0) points on day 42.
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