Nanoscope Therapeutics announces WHO selection of ‘sonpiretigene isteparvovec’ as international nonproprietary name for MCO-010
MCO-010 has been granted orphan drug designation by the FDA for both diseases and multiple mid- to late-stage clinical trials are ongoing.
The name "sonpiretigene isteparvovec" for MCO-010 was selected by the WHO Expert Advisory Panel of the International Pharmacopoeia and Pharmaceutical Preparations. (Adobe Stock image)
Nanoscope Therapeutics Inc. today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) has selected "sonpiretigene isteparvovec" for the nonproprietary name of the Company's MCO-010, an ambient-light activatable multi-characteristic opsin (MCO) optogenetic monotherapy to restore vision in patients with retinitis pigmentosa (RP) and Stargardt disease.
According to the company, MCO-010 has been granted orphan drug designation by the FDA for both diseases and multiple mid- to late-stage clinical trials are ongoing, including the company's Phase 2b multicenter, randomized, double-masked, sham-controlled RESTORE clinical trial for RP. Top line data from RESTORE are expected during the first quarter 2023.
The name "sonpiretigene isteparvovec" for MCO-010 was selected by the WHO Expert Advisory Panel of the International Pharmacopoeia and Pharmaceutical Preparations. MCO-010 reached the status of recommended INN after a period of public consultation and was included in the INN Recommended List 128, published in the No. 4 issue of the WHO Drug Information, Volume 36 in January.
“The WHO's INN system has facilitated the name of sonpiretigene isteparvovec for the active pharmaceutical ingredient, which is the foundation of our clinical development in several retinal degenerative diseases with high unmet need,” Samarendra Mohanty, PhD, president of Nanoscope, said in the news release. “We believe that finalizing this name is an important step towards potential future commercialization of MCO-010."
