Rhinovirus and COPD

The Overlooked Connection Fueling a Public Health Crisis

First-in-class rhinovirus treatment vapendavir nears critical 2026 Phase 2b clinical trial

With millions of Americans living with chronic obstructive pulmonary disease (COPD)—one of the top five causes of death in the United States—preventing and treating viral respiratory infections must become a public-health priority.

Rhinoviruses are the leading cause of acute COPD exacerbations, driving hospitalizations, accelerated lung decline, and mortality. With more than 170 distinct rhinovirus strains, development of a vaccine or monoclonal antibody is not feasible. As a result, direct-acting antiviral therapy represents the most viable pharmaceutical strategy for addressing rhinovirus infections in COPD patients.

Altesa BioSciences’ Chief Medical Officer (CMO) Kate Knobil, M.D. recently noted:

Vapendavir is currently the only direct-acting antiviral in development for rhinovirus, is Phase 2b-ready, supported by a substantial safety database for its stage of development, and well-positioned as a promising next-generation therapeutic approach.

[ European Respiratory Society (ERS) annual symposium]

Vapendavir: The only direct-acting antiviral currently in development for rhinovirus

Transcript

Rhinovirus is the most common cause of acute exacerbations of COPD. And maybe what I don’t think anyone else did bring up today, that is that there are over 170 distinct strains, and so development of a vaccine or a monoclonal antibody is just not feasible. And so antiviral therapy is really the main foreseeable pharmaceutical approach for the treatment of rhinovirus infections, and you already heard that the vapendavir is currently the only direct acting antiviral that’s currently in development for rhinovirus, and it is phase 2b- ready, and you’ve heard that it already has a pretty sizable safety database for the stage of development that we’re in right now.

Kate Knobil Bio

2026 Phase 2b Clinical Trial

The CARDINAL clinical trial is a Phase 2b multinational randomized placebo-controlled study in COPD patients experiencing rhinovirus infections that will enroll 900 people with COPD in the US and UK. The trial was designed to reflect real-world care models, proactively identifying and supporting those at greatest risk.

Karen Fusaro, Altesa BioSciences’ Senior V.P. of Clinical Development details several aspects of the Phase 2b clinical trial:

Partnering with COPD Foundation on Clinical Trial Design
Transcript
First, we need to design the right study that’s important in every possible way. We need to answer questions about safety and efficacy and how the drug works and all sorts of really important scientific questions. But in the meantime, we also have to make it feasible for the physicians who are running the study as well as for the patients. So we reached out to the COPD foundation. We’ve been excellent partners, or they’ve been excellent partners for us and helped us with study design. So they’ve reviewed our protocol and then they also helped us engage patients.

So we’ve conducted a round table review with COPD patients of the protocol. The operational aspects of the protocol, what we’re asking of the patients, which is a lot, and to try and help understand their needs, their wants, what we can do to make the experience better for them, because at the end of the day, they are our main partner.

Patient Navigators to Offer Support, Facilitate Needs
Transcript
The other thing that we are doing, which is the first time I’m doing this in a study is we’re hiring patient navigators. ultimately they are hired part of the study team, but their goal is to support the patients. So, they’re available for the patients to call if they have concerns about their diary or they’re testing or they’re not feeling well, or they wanna go to the hospital.

Anything that they need during the course of the study, they can call the patient navigator and in return the patient navigator’s gonna reach out to them too.

Trial Duration and Locations — U.S and U.K.
Transcript
The study’s gonna start in the beginning of next year. We’ll go on for about a year where we’ll be following COPD patients over time. like I mentioned before, the rate of patients getting sick is gonna be variable. And so we don’t know who’s gonna get sick or when they’re gonna get infected with rhinovirus, but ultimately, when they do, we will treat them, we’ll, randomize them to treatment. And so the study will be ongoing. The conduct of the study, probably about a year and a half once it gets started and it is ongoing, across the United States. We’re also gonna be, working with some of our partner sites in the uk where we have great relationships with physicians there as well.
Karen Fusaro Bio