Texas-based Moleculin is preparing to submit a request to the US FDA for Investigational New Drug for WP1122
Global CDMO, Sterling Pharma Solutions has signed an agreement with Moleculin Biotech to support the company's expanded development efforts for its potential COVID-19 treatment, WP1122.
Moleculin is a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumours and viruses. The company is preparing to submit a request to the US FDA for Investigational New Drug (IND) status for WP1122.
The agreement will see Sterling undertake final purification of the product at its site in Cary, North Carolina. It will also help ensure a reliable supply of the drug for preclinical studies and the anticipated clinical trials.
"In light of the added complexity surrounding drug production during the current COVID-19 pandemic, we wanted to make sure we had a reliable source of drug supply located here in the US," said Walter Klemp, Chairman and CEO of Moleculin. "We are expanding our planned preclinical studies for the IND, so our contract with Sterling Pharma Solutions helps us cover this increased demand in combination with our expected use in clinical trials."
Mat Minardi, President of US Operations at Sterling Pharma Solutions added: "It's a privilege to support companies at such a pivotal time for the pharma sector. The COVID-19 pandemic has brought into sharp focus the importance of innovative companies like Moleculin in the search for potential therapies."