ANA Therapeutics and Quotient Sciences today 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 will scale up the capsule formulation, characterize and optimize the manufacturing process and ensure continuity of drug product through clinical trials.
Collaboration Expedites Product Development for Pivotal Clinical
Trials
ANA Therapeutics, a Silicon Valley-based biotech startup, and Quotient Sciences, a leading provider of innovative drug development and
manufacturing solutions, today 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 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 and
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’s 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’s 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’s facility in Garnet Valley,
Pennsylvania.
About ANA Therapeutics
ANA Therapeutics is a Silicon Valley-based
biotech startup working to develop niclosamide as a safe, widely accessible
antiviral treatment for patients with COVID-19. A low-cost, scalable, and
well-tolerated compound, niclosamide has the potential to be a needed treatment
to help individuals who contract the novel coronavirus to beat it.
About Quotient Sciences
Quotient Sciences is an innovative global
pharmaceutical development, clinical and commercial manufacturing organization
providing services to the pharmaceutical and biotech industries. A combination
of specialized skills and agile integrated processes enables Quotient Sciences
to develop customized solutions which dramatically reduce the time and cost of
getting drugs to market. Everything we do is driven by a deeply held belief,
shared across the entire organization, that molecules need to become cures – fast.