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  • Writer's pictureRenovion

A breathe-easier breakthrough

Renovion, a UNC-affiliated startup, advances a breakthrough therapy to restore lung health and quality of life in patients with diseases that cause chronic inflammation of the airways.

Imagine what it would feel like to breathe each and every breath through a straw. Suffocation feels like it’s always just one short breath away. Your lungs are filled with mucus that is coupled with a chronic, hacking cough that you can’t shake. You cough at the most inopportune time – in the grocery store, in class or at work. It is an outward symptom of the cycle of mucus, inflammation and potential infection in your lungs.

For healthy people, mucus and coughing are merely nuisances, especially when fighting a cold or sinus infection. They signal that your body is trying to stay healthy by fighting off germs. But, for those with chronic inflammatory airway diseases such as non-CF bronchiectasis (NCFBRE) and chronic obstructive pulmonary disease (COPD), dealing with an excess of mucus is part of everyday life and can be debilitating.

The hard work by leaders of Renovion, a startup company affiliated with the University of North Carolina at Chapel Hill, have developed a novel therapy that restores mucus clearance and reduces inflammation in the lungs that will give these patients hope for a better quality of life. ARINA-1, a first-in-class therapy, addresses deficiencies in the innate immune system that occur in chronic inflammatory airway diseases.

Life-altering treatment restores lung health

“For patients with NCFBE and COPD, excess mucus is one of the issues with the greatest impact on quality of life. Broadly speaking, there’s no great alternative out there for these patients,” says Dan Copeland, the CEO of Renovion and a UNC Kenan-Flagler Business School alumnus. “Our goal with ARINA-1 is to help with mucus clearance without harmful side effects. We can actually help patients clear more mucus and reduce the mucus component of their disease.”

A nebulized therapy, ARINA-1 has the ability to restore lung health in patients with diseases that affect their airways, including non-CF bronchiectasis, COPD, and lung transplant. Given its strong track record for safety and efficacy, as well as its unique mechanism of action, ARINA-1 can significantly improve the lives of patients with often-debilitating chronic diseases that can lead to early death.

“The ARINA-1 treatment is life-altering for patients,” says Carolyn Durham, Renovion’s Chief Scientific Officer. “Being able to clear mucus more effectively and decrease mucus hypersecretion in the long term can improve quality of life and may improve long-term mortality rates.”

In NCFBE and COPD, thick mucus accumulates in the lungs and cannot be effectively cleared out of the airways. This can lead to mucus plugging and difficulty breathing, which can exacerbate inflammation in the airways and result in a vicious cycle of mucus and inflammation that damages the airway and makes it more susceptible to infection.

“If you have more mucus in your lungs, you’re probably going to attract more bacteria, which drives infection,” says Copeland. “So, by treating that mucus and inflammation, we can break the cycle with ARINA-1 by restoring critical components of the immune system to enhance mucus clearance and decrease pathological inflammation. And that will have a huge impact on patients.”

Novel technologies and partnerships

To deliver the ARINA-1 treatment more effectively, Renovion is partnering with PARI to deliver ARINA-1 via a nebulizer developed specifically for ARINA-1.

“Most nebulizers don’t deliver enough drug to the airway, and if you have an inflamed airway full of mucus, you need to get a lot of drug down there to make an impact,” says Durham. “We have partnered with PARI to develop a specific mesh for the nebulizer that delivers high concentrations of the drug into the airway to alleviate the mucus issue. We’re very fortunate to be able to get this medication into the hands and lungs of patients.”

Renovion has built on the foundation of research performed by David Henke, MD, MPH, Associate Professor of Medicine in the UNC School of Medicine’s Division of Pulmonary Diseases and Critical Care Medicine, and Roland Arnold, PhD, Professor in the UNC School of Dentistry. Renovion has licensed a patent from UNC and continues to build intellectual property around the asset.

“Taking a 15-minute nebulizer just twice a day provides a huge benefit to patients with these debilitating chronic diseases,” says Durham. “They don’t feel like they’re suffocating all the time and can be more active, which in turn may help their disease not progress as quickly.”

To help get ARINA-1 into patient’s hands faster, Renovion recently partnered with the COPD Foundation, a national, patient-centered organization committed to preventing and treating all aspects of COPD, non-CF bronchiectasis and nontuberculous mycobacterial (NTM) lung disease. The partnership allows the Renovion clinical programs to progress with maximum efficiency. The COPD Foundation recognized the potential for ARINA-1 and how it could have a significant impact on NCFBE and COPD patients.

“The partnership with the COPD Foundation will help us get this drug into the hands of patients more quickly than we would have otherwise,” says Copeland. “They also bring a distinguished network with them for future partnership opportunities, as well as advice from key opinion leaders,” adds Durham.

Carolina connections lead to entrepreneurial insights

Since the company’s founding in 2013, Renovion has used innovation and entrepreneurial resources at Carolina, including KickStart Venture Services, startup consulting services from the Office of Technology Commercialization, and Innovate Carolina’s patent landscape and market research team. Through a $50,000 grant from KickStart, Renovion was able to launch the company and gather preliminary data in lung transplant patients. By working with Cindy Reifsnider, who leads Innovate Carolina’s market patent landscape and market research team, Renovion was able to ensure its patent strategy was on the right track. Through continued development, Renovion has demonstrated that ARINA-1 has been shown safe and effective in early trials.

“Cindy was one of the first people I met through the UNC Innovation network when Renovion was first getting off the ground,” says Durham. “She did the initial patent landscaping work for us, and it was really critical as we were developing the first patent. We needed to be able to carve out a niche for ourselves, and her expertise in that field and the way she navigates patent landscape analyses was very helpful for us, especially as a new company. She played a crucial role in those very first steps.”

Drawing from their own innovation journeys, both Copeland and Durham give back to other innovators and entrepreneurs through the UNC Kenan-Flagler Business School’s Venture Capital Investment Competition (VCIC), which is the world’s largest venture capital competition. Each year, it attracts more than 120 university and graduate school teams, giving students that chance to spend a day acting as venture capitalists who assess startup investments and startups the chance to get feedback and connections from real investors who serve as judges. Copeland and Durham appreciate the lessons they have learned throughout Renovion’s growth as a company. VCIC and other opportunities to engage with startups gives them a chance to offer guidance to others who may want to follow a similar path in launching a venture.

“Always think about what makes your company different, what makes it unique,” says Copeland. “It’s also important to be flexible. You may start at one place and then end up with some great data that comes out in a different therapeutic area, and it takes you down a different path. So just be open to really thinking about how are you different, how you can help patients in a way they’re not being helped today.”

“We’re entrepreneurial folks, but we don’t know everything,” adds Durham. “Identifying where you need expertise is really important. There can be a mentality of ‘This is my baby, and I want to do everything,’ but that mentality can lead to sleepless nights and not the best outcomes.”

Renovion hopes to have ARINA-1 approved by the FDA and available for lung transplant patients sometime in 2024. They are currently initiating Phase 2 trials in NCFBE and COPD. The company is also looking at ways the treatment can potentially be used in tracheostomy patients.

“For patients who are coughing up mucus every day and just don’t feel well, we have seen efficacy data that shows we can help,” says Copeland. “We can change the lives of these patients for the better.”



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