The company has completed evaluation on candidates and selected a single drug candidate to move forward into clinical trials.
Akari Therapeutics announced it has completed evaluation on long-acting PAS-nomacopan candidates and has selected a version the company plans to take into clinical trials for the treatment of geographic atrophy (GA).
In a press release from the company,1 it describes the selected version as having “a product profile with characteristics important for a GA therapy, including fully active drug potency, planned small (<100µL) injection volume, viscosity enabling intravitreal injection with a fine needle, and pre-clinical half-life that supports a potential clinical dose interval of 3 months or longer.”
Akari remains on track and plans to submit an IND application to the US FDA in the first half of 2024, and plans on starting clinical trials in the second half of 2024.1 Wacker Biotech GmbH will be the manufacturing partner to support production of PAS-nomacopan for use in clinical trials.
Wacker Biotech is a contract development and manufacturing organization (CDMO) of therapeutic proteins, live biotherapeutic products (LBPs), plasmid DNA (pDNA), messenger ribonucleic acid (mRNA) and vaccines based on microbial systems.1
“We selected Wacker among competing CDMOs because their proprietary bacterial expression technology Esetec provides a significant yield of fully refolded PAS-nomacopan, and we believe working with Wacker provides the best path to GMP manufacturing of long-acting PAS-nomacopan for use in GA clinical trials,” said Miles Nunn, PhD, chief scientific officer of Akari.
Rachelle Jacques, Akari president and CEO, talked about the upcoming application and trials in a news release from the company.
“Our pre-clinical work has focused on identifying a single version of long-acting PAS-nomacopan with the strongest product profile to bring forward into clinical trials,” Jacques said.
“As we complete the final stages before anticipated submission of an IND in first half of 2024, we are confident we’ve chosen the asset that positions us to succeed in the clinical trials we expect to initiate in the second half of 2024.”
According to the company, long-acting PAS-nomacopan is being developed with the potential to address 3 areas of patient need in GA:1
The company states the dual mechanism of PAS-nomacopan may offer important advantages for patients including the benefits of intravitreally-administered complement C5 inhibition in slowing the progression of GA lesions, while also providing leukotriene B4 (LTB4) inhibition that has the potential to help prevent VEGF-A overexpression, reducing the likelihood of CNV.1