Akari announces pre-clinical development progress toward IND for GA treatment

Akari Therapeutics announced updates on progress in the pre-clinical development program for long-acting PAS-nomacopan as a potential treatment for geographic atrophy, GA, secondary to dry age-related macular degeneration, dAMD."Our pre-clinical development work has been focused on engineering, evaluating and selecting the version of long-acting PAS-nomacopan that will achieve the maximum dose interval, while not sacrificing manufacturability, as well as securing our intellectual property," said Rachelle Jacques, President and CEO of Akari. "We have made significant development progress and I am pleased we are on track for an IND application submission next year to enable clinical trials for this potentially important treatment option for patients with geographic atrophy." Long-acting PAS-nomacopan is in pre-clinical development as a treatment for GA that addresses areas of significant unmet patient need including a long dose interval and reduction in the risk of choroidal neovascularization. The new PAS-nomacopan versions are fully active, with binding kinetics to complement C5 equivalent to the parent drug nomacopan and earlier PAS-nomacopan versions. New versions show high expression levels in recombinant protein manufacturing. Development of PAS-nomacopan has progressed from lab scale to pre-GMP optimization. With these advances, Akari is on track to select the version that will advance to GMP manufacturing and non-clinical safety studies in preparation for an investigational new drug application and the start of clinical trials in GA. Importantly, the new versions of PAS-nomacopan have significantly increased hydrodynamic radii compared to previous versions, increasing the PAS-nomacopan target dosing interval beyond 3 months with the potential for only 3 or 4 intravitreal injections a year.