The Register Citizen (Torrington, CT)
State firm’s COVID-19 treatment advances
GUILFORD — A local pharmaceutical company developing a treatment for COVID-19 patients is entering Phase II of its efforts to get the drug approved by the federal Food and Drug Administration.
AI Therapeutics is working with Yale University to conduct the Phase II study on newly diagnosed COVID-19 patients. The study will evaluate the safety, tolerability and efficacy of its drug candidate, LAM-002A, also known as apilimod.
In Phase II studies, researchers administer the drug candidate to a group of patients with the disease or condition for which it is being developed.
These studies typically involve a few hundred patients, according to FDA officials, and aren’t large enough to show whether the drug will be beneficial. AI Therapeutics’ Phase II study will enroll up to 142 patients.
The drug was proven safe in previous trials involving more than 700 patients for treatment of autoimmune diseases and follicular lymphoma, according to a press release from Yale University. The FDA has given the drug fast-track status and has designated it an orphan drug for treatment of lymphoma.
LAM-002A has been shown in several studies to interfere with the entry and trafficking of the SARSCoV-2 virus in cells, according to company officials.
SARS-CoV-2 is the virus responsible for COVID-19.
AI Therapeutics develops drug candidates through a proprietary artificial intelligence algorithm for matching drugs to new indications.
Jonathan Rothberg, AI Therapeutics’ co-founder and a member of the company’s board of directors, said the company’s employees are doing all they can “to make sure our drug, LAM-002, has the best shot to help (treat the disease).”
“Working with Yale is the perfect place to start,” said Rothberg, who also is an adjunct professor of genetics at the university. He is best known in the Connecticut business community as having created nine companies, including CuraGen Corp.
“LAM-002A holds promise to be a powerful new therapy for COVID-19 patients to prevent progression of disease, hopefully avoiding the need for hospitalization,” said Murat Gunel, professor of neurosurgery and professor of genetics and neuroscience at Yale. Gunel is AI Therapeutics’ chief science adviser and has a financial interest in the company.
Gunel said if the trial is successful, it could be expanded to assess whether it would help prevent someone who is exposed to the coronavirus from coming down with COVID, particularly in high-risk populations such as the elderly in nursing homes, health care and front-line workers, or people in underserved communities, according to the Yale release.
Dr. Charles Dela Cruz, director of the Center for Pulmonary Infection Research at Yale University, said working with the university provides AI Therapeutics with an “outpatient treatment option for patients who are symptomatic in order to prevent progression of disease and hospitalization for COVID-19.” Dela Cruz is the principal investigator of the clinical trial.
As the clinical trial is progressing, AI Therapeutics is preparing to make the LAM-002 accessible: It has 70,000 doses ready to go, 70,000 on the way, and the compound is being prepared for nearly 5 million more doses.