Akari Therapeutics(US:AKTX)2019-09-16 17:45Nomacopan (Coversin) Overview - Nomacopan is a bifunctional inhibitor of C5 & LTB4, targeting orphan inflammatory & autoimmune diseases with limited treatment options[4] - The company is focused on four orphan conditions currently in Phase II and Phase III studies, utilizing subcutaneous and topical delivery methods[4] - The company projects peak sales targets of $500 million, including follow-on indications, highlighting the market potential of Nomacopan[6] Clinical Development and Upcoming Milestones - Positive initial clinical readouts have been observed across clinical studies, demonstrating the potential of Nomacopan[6] - Multiple mid-stage clinical study readouts are expected in 2019-2020 from TMA, BP, and AKC, representing potential value inflection points[8] - A pivotal trial for pediatric HSCT-TMA is anticipated to commence in Q4 2019, with potential expedited approval based on a single pivotal study[26] Clinical Data and Efficacy - In a Phase II PNH study, six patients were transfusion-dependent prior to the study, and two-thirds became transfusion independent[18] - Initial data from a Bullous Pemphigoid study showed blisters/erosions dropped by a mean of 45% by Day 7, 75% by Day 21, and 87% by Day 42 in the first three patients[42] - Initial AKC clinical data showed rapid improvement in composite clinical scores in the first two patients to Day 56, with the study expanding to additional clinical centers[52] Financial Information - The company has a $20 million financing facility with Aspire Capital, with approximately $5.5 million drawn down to date[69][70]