A Long-Lasting Drug Against Flu: Jeff Stein on The Long Run

Jeff Stein is today’s guest on The Long Run. He’s the CEO of San Diego-based Cidara Therapeutics.

Jeff Stein, CEO, Cidara Therapeutics

Jeff has led teams that have successfully developed a novel antibiotic, and a novel antifungal, all the way through FDA approval. This latest project with an antiviral could be the most important of his career.

Cidara has a platform for making drug-Fc conjugate therapies, which can be engineered to treat a variety of diseases in a long-lasting injection.

The company’s current top priority – one with global health and pandemic preparedness implications — is called CD-388.

Cidara’s looked all the small molecule antivirals for influenza that have been developed and thought of a way to come up with what hopefully will be a compound with high efficacy, a clean safety profile, and a chance to be given in a single shot that will last an entire flu season.

For the scientists out there, it’s a small molecule neuraminidase inhibitor conjugated to an Fc fragment of a human antibody. That conjugation part makes the drug last longer in the bloodstream. Cidara thinks its small molecule can be injected once every six months, either via intramuscular or subcutaneous routes. For more on the science, see a recent preprint article on BioRxiv.

Based on cell-based assays, animal and human Phase I and II studies to date, Cidara believes it will provide universal protection against all circulating strains of influenza – the A and B types. That would include the H5N1 bird flu strains that have created some concern by leaping to cattle, and in a few cases, to humans who work in close proximity to cattle.

This treatment will be tested this fall in a 5,000-subject study, in a variety of doses and against placebo. If CD-388 can reproduce the broad-spectrum and long-lasting antiflu activity that it has shown in previous studies, it could have a very important drug to help governments around the world prepare for future flu pandemics. Because of its biological way of working, it should be effective for many more people than the current generation of flu vaccines, should have several years of shelf life for government stockpiles, and should be helpful for even the immunocompromised vulnerable populations who aren’t likely to gain protection from vaccines.

There’s also a somewhat circuitous business story here with CD-388, as Cidara developed it, worked on it with Johnson & Johnson for a while, had to buy it back at one point, and recently secured $240 million in funding to take it through a big 5,000-subject study on its own.

There’s a lesson in here for scientific entrepreneurs about resilience and staying power.

Now please join me and Jeff Stein on The Long Run.

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