Aridis CEO Confident Inhaled Antibody Formulation Will Play a Key Role in Controlling COVID-19
Aridis Chief Executive Officer Vu Truong pictured above. Photo courtesy of Aridis.
Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody.
California-based Aridis is developing AR-711, a neutralizing monoclonal antibody discovered from convalescent COVID-19 patients that can be delivered to patients in an inhaled formulation. That means more of the medication will make its way to the lungs, Truong told BioSpace in an interview.
Because the medication is administered straight to the lungs, Truong said the dosage is much lower than current monoclonal antibody treatments from Regeneron and Eli Lilly that are seeking Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Both of those treatments deliver an 8,000 mg dose, but only a small percentage of the medication makes its way to the lungs, Truong said.
“The drugs aren’t being delivered to the place it needs to be, that’s where the infection is, that’s the organ where SARS-Cov-2 infects,” Truong said. “An inhaled treatment will help alleviate this pandemic.”
Comparing his company’s antibody treatment to an asthma inhaler, Truong said the medication can be used by most anyone who has a mild-to-moderate COVID-19 infection, or who may have been exposed to the virus but isn’t showing symptoms, including asymptomatic patients. Approximately 90% of patients infected with COVID-19 do not require hospitalization, but while they attempt to recover at home, they pose a risk to infect others, or their condition could worsen.
“Having a convenient way to self-medicate with the simplicity of an asthma inhaler where the drug is delivered directly to the infection site can have a transformative impact on patients’ lives, expand treatment coverage and ultimately reduce global transmissibility,” Truong said.
Antibody treatments are effective in treating COVID-19 patients, Truong said. Regeneron’s REGEN-COV-2, which is currently in Phase III trials, was touted by President Donald Trump, who was given the high-dose treatment after being diagnosed with COVID-19 earlier this month. Truong said AR-711, which has yet to move to clinical trials, should be able to provide the same response in patients, but with a much smaller dosage.
“We have a more potent antibody and a better way to deliver it where it needs to go,” he said.
In animal models, AR-711 eliminated detectable SARS-CoV-2 virus at all dose levels tested, with the lowest lung deposited dose of 0.03 mg/kg, the company announced last week. Not only is the dosage much lower, Truong noted that models show the antibody should last longer in patients than the other two treatments that are developmentally ahead. AR-711 is engineered to be long-acting in blood for up to six to 12 months, he said.
Truong anticipates AR-711 will enter human testing in early 2021. He said the company will be aggressive in its developmental time frame as other companies have been in their responses to the pandemic. While Regeneron and Eli Lilly, as well as other companies, may be farther along in clinical development than Aridis’ asset, Truong said that does not worry him.
“We’re not the me-first program, we’re the me-better program,” he said. “We think we have something superior.”
While there are likely to be multiple vaccines against COVID-19 available when AR-711 completes clinical testing, Truong said a market will remain for the inhaled treatment due to the percentage of patients who may not receive a vaccine or benefit from the preventative medication.
If AR-711 does make it through clinical testing, Truong said the company will be able to scale its manufacturing to meet demands in the United States and across the globe. The company uses a proprietary formulation to stabilize the antibody as it’s converted to an aerosol formulation. From there, the treatment can be self-administered with a wide variety of commercially available nebulizers.
Although there is still a significant amount of work ahead for Aridis on AR-711, Truong said he is confident the company has a product that will be critical to controlling the COVID-19 pandemic.