FDA grants Insilico Orphan Drug Designation for the treatment of Idiopathic Pulmonary Fibrosis
Insilico Medicine ("Insilico"), a clinical-stage end-to-end AI-driven drug discovery company, announced that they have received Orphan Drug Designation to INS018_055 from the U.S. Food and Drug Administration (FDA) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
IPF, a chronic lung disease, can lead to an irreversible decline in lung function and there is a huge demand for medicine needs globally.
In early 2022, the first phase clinical trial of INS018_055 started in New Zealand and China and was completed successfully. The result showed that the drug was safe to be used. Insilico already decided to start the second phase clinical trial in early 2023.
Feng Ren, PhD, Co-CEO and Chief Scientific Officer of Insilico Medicine said: “ INS018_055 is a potential first-in-class drug candidate discovered by Insilico's generative AI platform, Pharma.AI.
“The FDA’s orphan drug designation for the IPF indication is an important milestone in the development of INS018_055. Insilico scientists are now further advancing clinical validation and accelerating the project to meet clinical needs and benefit patients worldwide.”
The FDA's Orphan Drug Designation program supports the development of drugs for rare diseases which affect less than 200,000 people in the United States.
After receiving orphan drug designation from the FDA, Insilico can benefit from a series of government support to continue developing the INS018_055. This includes federal grants, tax credits for qualified clinical trials, prescription drug user fee exemptions, and a seven-year marketing exclusivity period upon FDA approval.
In addition, filmmakers and students are welcome to contribute to the Documentary Hackathon (“Docuthon”). Throughout the progress of AI-powered drug discovery during the previous years, Insilico and its partners worldwide have collected a large amount of video footage and content. They are now available to be used creatively.
Potential participants can submit their applications through the Docuthon page.