Peter Vozzo Westwicke +1 (443) 213-0505peter.vozzo@westwicke.com, Sukaina Virji / Lizzie SeeleyConsilium Strategic Communications +44 (0)20 3709 5700Akari@consilium-comms.com, T: +44 (0)20.8004.0261 We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Clive Richardson, interim CEO of Akari Therapeutics, said, “Fast Track designation provides our HSCT-TMA clinical program a pathway for an expedited approval for nomacopan, and we plan to commence a pivotal trial in the fourth quarter of 2019. In the U.S., a proposed multi-center randomized clinical program is in regulatory submission following the current treatment of patients via expanded access programs. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. A comfort score measured after each eye drop installation showed the drug was comfortable and well tolerated. Second Quarter 2020 Financial Results Akari recently received FDA approval for an IND for treatment with topical nomacopan which opens up the potential to broaden our topical ophthalmological program. Fast Track designation is intended to facilitate the development and expedite the review of new drugs which show promise in treating serious or life-threatening conditions and address unmet medical needs. Patients will only have their OCS tapered if their disease continues to respond to treatment as the OCS dose is decreased. You should not place undue reliance upon the Company’s forward looking statements. As a consequence, the Company’s ongoing trials have been halted or disrupted. CONDENSED CONSOLIDATED BALANCE SHEETSAs of June 30, 2020 and December 31, 2019 (in U.S.
In all four efficacy categories (signs, symptoms, visual acuity and tear film break up) the four nomacopan treated AKC patients achieved a higher improved mean score than the four placebo AKC patients, however, the patient numbers are too small to show statistical significance on efficacy measures between the two treatment groups. F: 646.843.9352 Nomacopan has been shown in clinical trials to inhibit both complement C5 activation and leukotriene B4 (LTB4), and has significant potential to simultaneously inhibit both microthrombi as well as block multiple cytokines (the cytokine storm) which together drive COVID-19 pneumonia and associated organ damage.
“Akari continues to make good clinical progress, and since the beginning of the year has successfully completed its Phase II BP program and now has a clear pathway towards U.S. regulatory approval from the FDA. During the first quarter of 2020, Akari initiated a pivotal Phase III trial for HSCT-TMA with nomacopan following the opening of an Investigational New Drug (IND) application by the FDA.
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