Samenwerking versnelt de productontwikkeling voor cruciale klinische onderzoeken

FOSTER CITY, Californië & NOTTINGHAM, Engeland– (BUSINESS WIRE) – ANA Therapeutics, een in Silicon Valley gevestigde biotech-startup, en Quotient Sciences, een toonaangevende leverancier van innovatieve oplossingen voor geneesmiddelenontwikkeling en -productie, hebben vandaag een samenwerking aangekondigd ter ondersteuning van de productie van ANA Therapeutics ‘kandidaat-geneesmiddel, ANA001 (niclosamide-capsules), die ze ontwikkelen als een mogelijke behandeling voor COVID-19. Als onderdeel van de samenwerking zal Quotient de capsuleformulering opschalen, het productieproces karakteriseren en optimaliseren en de continuïteit van het geneesmiddel garanderen door middel van klinische onderzoeken.

Laboratoriumexperimenten hebben aangetoond dat niclosamide de replicatie van SARS-CoV-2 (het virus dat COVID-19 veroorzaakt) stopt, waardoor het een veelbelovende kandidaat is om de verspreiding van COVID-19 te verminderen. Niclosamide werd eerder door de FDA goedgekeurd als een behandeling voor lintworm en hoewel het momenteel niet in de VS op de markt wordt gebracht, staat het op de lijst van essentiële geneesmiddelen van de Wereldgezondheidsorganisatie en wordt het al decennia gebruikt om miljoenen mensen over de hele wereld veilig te behandelen.

ANA Therapeutics and Quotient Sciences Announce Partnership to Manufacture Niclosamide Drug Candidate as a Potential Treatment for COVID-19

Collaboration Expedites Product Development for Pivotal Clinical Trials

FOSTER CITY, Calif. & NOTTINGHAM, England–(BUSINESS WIRE)– 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.

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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.

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