ANA Therapeutics, a Silicon Valley-based biotech startup, and Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, announced a partnership to support the manufacturing of ANA Therapeutics’ drug candidate, ANA001 (niclosamide capsules), which they are developing as a potential treatment for COVID-19. As part of the collaboration, Quotient Sciences will scale up the capsule formulation, characterize and optimize the manufacturing process and ensure continuity of drug product through clinical trials.
Laboratory experiments have shown niclosamide stops SARS-CoV-2, the virus that causes COVID-19, from replicating, making it a promising candidate for reducing the spread of COVID-19. Niclosamide was previously approved by the FDA as a treatment for tapeworm. Although not currently marketed in the U.S., it is on the World Health Organization’s List of Essential Medicines and has been used for decades to safely treat millions of people around the world.
“We have selected Quotient Sciences as our development and manufacturing partner and our plan is simple,” said Andrew Bartynski, COO, ANA Therapeutics. “Niclosamide has the potential to be an effective antiviral agent to combat COVID-19, and our top goal is to complete a clinical trial to determine its efficacy in treating patients with COVID-19. Quotient Sciences' speed and agility will play a key role in reaching that important milestone.”
Mark Egerton, Ph.D., CEO of Quotient Sciences, said, “We are proud to partner with ANA Therapeutics in their pursuit of a treatment to fight this coronavirus pandemic. Our experience and flexible manufacturing approaches will enable ANA Therapeutics to initiate clinical testing in an accelerated timeframe.”
Under the scope of the agreement, ANA Therapeutics will access Quotient Sciences' formulation and manufacturing expertise to develop and rapidly supply drug product for pivotal clinical trials in Q3 2020. The program will be conducted at Quotient Sciences' facility in Garnet Valley, Pennsylvania.
As of January 2021, ANA Therapeutics has been acquired by NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company.