NGM Biopharmaceuticals Inc. (NASDAQ: NGM) has announced that the US FDA has granted its monoclonal antibody products designed to inhibit complement C3, NGM621, a Fast Track designation for the treatment of people with geographic atrophy secondary to age-related macular degeneration. The company is currently evaluating NGM621 in a second phase CATALINA trial, and it expects top-line results to be released in Q4 2022.
NGM621 granted Fast Track designation
Head of Ophthalmology at NGM Bio, Erin Henry, said, “The FDA’s decision to grant Fast Track designation to NGM621 is an important milestone underscoring the high unmet medical need for patients with geographic atrophy as well as the potential of NGM621 to alter the course of this disease for those underserved patients.”
Geographic atrophy patients lose about one vision line on the eye chart every year, limiting their ability to accomplish routine chores like reading and reading and the quality of life and independence. The designation, along with the possibility of more regular interaction with the FDA, could help NGM Bio bring NGM621 to patients.
Fast Track designation helps in the development of new therapies for serious illnesses
The FDA created the Fast Track program to help develop and review new therapies designed to treat serious illnesses or meet unmet medical needs. Fast Track-designation programs have the chance to discuss with the FDA early and frequently during the development and evaluation process, and if applicable criteria are met, they may be qualified for priority review and speedy clearance.
GM621 is a humanized Immunoglobulin 1 monoclonal antibody candidate intended to adhere to complement C3 action and suppress it for a long time. The drug is administered through an intravitreal (IVT) injection and is currently under evaluation at four and eight-week intervals. M Single and multiple and single IVT injections seemed to be well tolerated and safe in the NGM621 first phase research. NGM621’s great affinity adsorption to C3 has shown the possibility for strong C3 suppression in preclinical studies, and NGM Bio’s pharmacodynamics/ pharmacokinetics modelling has indicated significant drug coverage for every-eight-week dosage.
