Akari Therapeutics, Plc AKTX announced positive data from the part A of an early-stage study on its lead pipeline candidate, nomacopan, currently being developed for treating moderate to severe atopic keratoconjunctivitis (AKC). The phase I/II TRACKER study evaluated the safety and efficacy of topical nomacopan for addressing the given indication. AKC currently has no approved therapies.
Nomacopan is a C5 complement inhibitor that specifically inhibits leukotriene B4 (LTB4) activity. Complement component C5, the target of Nomacopan, is mostly found in the blood.
Shares of Akari inched up 2.3% following this news on Wednesday. In fact, the stock has surged 39.5% so far this year, outperforming the industry’s rise of 5.2%.
In part A of this study, three patients received nomacopan eye drops twice daily for up to 56 days in addition to the standard of care — cyclosporin. All patients afflicted with AKC had received the maximum standard of care dose for at least three months prior to treatment with nomacopan and continued with the same during the course of the study.
The secondary objective of the study was to determine the efficacy as assessed by the standard composite scoring system. Overall, the nomacopan achieved a mean composite clinical efficacy score of 55% for patients receiving treatment for 56 days.
The nomacopan eye drop was found to be comfortable and well-tolerated with no serious adverse events reported. It also reduced corneal damage.
Following this positive outcome, the independent safety committee has lent its nod for the study to proceed to the next stage of development. The Part B portion of the program has already started recruitment with data read-out expected in the fourth quarter of 2019.
Meanwhile, apart from AKC, nomacopan is being evaluated for three other indications, namely bullous pemphigoid (BP), thrombotic microangiopathy (TMA) and paroxysmal nocturnal hemoglobinuria (PNH). A successful approval of Nomacopan for any of this autoimmune disease is critical to Akari’s long-term growth.
Zacks Rank & Stocks to Consider
Akari currently carries a Zacks Rank #5 (Strong Sell).
Better-ranked stocks in the healthcare sector include Acorda Therapeutics, Inc. ACOR, Repligen Corporation RGEN and Merus N.V. MRUS, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
Repligen’s earnings estimates have been revised 12% upward for 2019 and the same for 2020 over the past 60 days. The stock has soared 53.8% year to date.
Merus’ loss per share estimates have been narrowed 22.2% for 2019 and 17.2% for 2020 over the past 60 days. The stock has risen 8.1% so far this year.
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