DAVIS, Calif.—Biopharmaceutical startup InVixa Inc. has announced an exclusive licensing deal with the University of California, Davis (UC Davis) centered on COVID-19. InVixa is developing inhaled statins for the treatment of COVID-19, and the agreement grants the company rights to intellectual property developed at UC Davis to commercialize inhaled statins for the treatment of COVID-19 and other viral respiratory diseases. No financial details were released.
Statins are widely prescribed for lowering cholesterol, but InVixa believes they also have a future in respiratory disease. Statins inhibit the mevalonate pathway, which is a metabolic cascade that plays a role in a variety of pathological processes in the body, and partially blocking this pathway is expected to help decrease lung inflammation and reduce disease severity in COVID-19 patients.
“InVixa is developing inhaled statin therapies that could treat severe lung disease caused by COVID-19. Our initial focus will be to treat hospitalized patients to prevent progression to respiratory failure using our novel inhaled statin formulation,” said InVixa’s scienti?c co-founder and chief medical officer Dr. Amir A. Zeki. “There is also longer-term potential to develop treatments for those with mild symptoms in the outpatient setting, as we currently do for influenza. We’re delighted to have a license with UC Davis given their commitment to fostering new discoveries and innovation, their ongoing support as a leading academic institution, and their dedication to improving health in our society particularly in the wake of this global pandemic.”
This work began with Zeki, who is also an associate professor in the Division of Pulmonary and Critical Care Medicine at UC Davis. He started looking into the use of statins to treat asthma and chronic obstructive pulmonary disease back in 2007. Orally administered statins had mixed results, so Zeki began looking into inhaled formulations instead.
“Depending on the statin tested, we found we could give appropriate statin doses via the airways which were well-tolerated and with beneficial effects,” Zeki explained in a press release. “That is when we pivoted to seeing this as a large opportunity to develop better treatments for our patients.”
He added, “The inhaled delivery approach allows for statin doses with a potentially greater local airway therapeutic effect. Given what we know of statin pharmacokinetics, their physiochemical properties, and generally low oral bioavailability—as well as prior negative, or equivocal, clinical trials using oral statins to treat other respiratory conditions—we believe our approach has a strong chance of achieving a beneficial clinical effect in COVID-19.”
Prior research of patients taking oral statins regularly prior to and during illness saw faster recovery times from the flu and lower mortality rates. A study by a UC San Diego Health team found that patients taking oral statins saw a reduced risk of developing severe COVID-19 and saw faster recovery times, and a retrospective clinical in China looked at nearly 14,000 patients and found that statin use led to a significant drop in mortality among COVID-19 patients.
Zeki's team, in collaboration with UC Davis virologists, worked on cell culture studies in 2020, and will advance to rodent models of COVID-19 this year to evaluate the use of inhaled statins against the virus. As noted in a UC Davis press release, Zeki's lab is working with “primary human airway epithelial cells grown in air-liquid interface to elucidate governing mechanisms,” and is collaborating with Prof. Stefan Rothenburg in the Department of Medical Microbiology and Immunology. Zeki is also preparing for animals studies of inhaled statins along with Prof. Lark Coffey in the Department of Pathology, Microbiology, and Immunology at the School of Veterinary Medicine.
“This is another excellent example of leveraging UC Davis Health’s scientific resources and entrepreneurial spirit to explore solutions for crucial health care needs. I applaud Dr. Zeki and his team for pursuing novel approaches based on their direct clinical experiences and research. There is a tremendous need to help patients facing respiratory failure, which has been the leading cause of mortality for patients with COVID-19,” stated David Lubarsky, vice chancellor for Human Health Sciences and CEO of UC Davis Health.
InVixa is finalizing preclinical testing to prepare for advancing a lead candidate into human clinical testing, with preclinical results expected early in 2021.