Akari Therapeutics PLC (ADR)(NASDAQ:AKTX) Reports Regulatory Progress


Akari Therapeutics PLC (ADR)(NASDAQ:AKTX) reported that following advice from a latest FDA Type B End of Phase 2 Meeting, it intends to progress its lead investigational product, Coversin™, towards Phase 3 clinical trials in Paroxysmal Nocturnal Hemoglobinuria in Q1 2018.

Dr. David Horn Solomon, the CEO, expressed that following their recent FDA meeting, they are working to commence a Phase 3 clinical study of Coversin in PNH in Q1 2018. They will continue to work with the FDA, gaining from their Fast Track status in the EMA, and with the United States towards filing of a MAA and BLA, respectively, for Coversin in PNH.

The details

Akari intends to carry out two Phase 3 clinical trials: CAPSTONE, in naïve Paroxysmal Nocturnal Hemoglobinuria patients where eculizumab is not the standard treatment, with co-primary clinical objectives based on transfusion and hemoglobin data, and ASSET, a Phase 3 clinical trial switching Paroxysmal Nocturnal Hemoglobinuria patients from eculizumab, the prevailing standard of care treatment in Paroxysmal Nocturnal Hemoglobinuria in the U.S., to cure with Coversin.

The U.S. FDA indicated that providing efficacy and safety data from the firm’s clinical studies for the planned count of unique PNH patients on Coversin for over one year appears reasonable, subject to assessment of the actual data upon filing. The count proposed comprises patients having C5 polymorphisms discussing eculizumab resistance.

Dr. Solomon expressed that Akari continues to gain momentum in its complement focused treatment by advancing Coversin towards Phase 3 in Paroxysmal Nocturnal Hemoglobinuria and Phase 2 in aHUS. With Coversin administered subcutaneously, patients may show greater independence following self-administration.

Phase 3 trials are also planned for numerous other indications where Coversin’s impact on both the leukotriene and complement pathways play a role. Its two major targets in this segment are atopic keratoconjunctivitis and severe bullous pemphigoid. Akari is a biopharmaceutical firm focused on the commercialization and development of innovative therapeutics to cure inflammatory and orphan autoimmune diseases.

This report is for information purposes only, and is neither a solicitation or recommendation to buy nor an offer to sell securities. Financials Trend is not-a-registered-investment-advisor. Financials Trend is not a broker-dealer. Information, opinions and analysis contained herein are based on sources believed to be reliable, but no representation, expressed or implied, is made as to its accuracy, completeness or correctness. The opinions contained herein reflect our current judgment and are subject to change without notice. Financials Trend accepts no liability for any losses arising from an investor's reliance on the use of this material. Financials Trend sometimes gets compensated up to one hundred and fifty thousand dollars per month for featuring particular stocks. See site disclaimer for complete compensation. Financials Trend and its affiliates or officers currently hold no shares of these stocks. Financials Trend and its affiliates or officers will purchase and sell shares of common stock of these stocks, in the open market at any time without notice. Financials Trend will not update its purchases and sales of these stocks in any future postings on Financials Trend's websites. Certain information included herein is forward-looking within the context of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning manufacturing, marketing, growth, and expansion. The words "may", "would," "will," "expect," "estimate," "anticipate," "believe," "intend," " project," and similar expressions and variations thereof are intended to identify for ward-looking statements. Such forward- looking information involves important risks and uncertainties that could affect actual results and cause them to differ materially from expectations expressed herein. *Financials Trend does not set price targets on securities. Never invest into a stock discussed on this web site or in this email alert unless you can afford to lose your entire investment.