Liquidia Technologies, headquartered in Research Triangle Park, North Carolina, launched a successful initial public offering on July 25, raising $50 million. The company spun out of the University of North Carolina at Chapel Hill in 2004 and has been working on developing what it calls PRINT technology. Neal Fowler, the company’s chief executive officer, and Kevin Gordon, Liquidia’s president and chief financial officer, took time out to talk with BioSpaceabout the company and where it’s headed.
The company’s PRINT technology uses a proprietary particle molding technology with a modular, roll-to-roll manufacturing process that is used for drug formulations. Fowler says, “We were the first company to uniquely engineer any aspect of a particle, whether that be size, shape or chemistry, compared to particle technologies of the past, where there is an inherent variability in some of those attributes. For example, typically you end up with a bell curve of different sizes and shapes, and when you load therapeutics into those particles, you’ll correspondingly get variability in terms of efficacy and safety.”
So what Liquidity’s PRINT tech allows for is a decrease in the variability of molecules used in drug deliverables, which allows for better efficacy and safety. In other words, it makes drugs better.
It has two compounds in its pipeline. The first is LIQ861, which is a dry-powder inhaler for pulmonary arterial hypertension (PAH). It is being developed under the U.S. Food and Drug Administration (FDA)’s 505(b)(2) pathway, which allowed the company to move from a successful Phase I clinical trial to its current Phase III clinical trial.
Liquidia’s LIQ861 is an inhaled dry-powder formulation of treprostinil designed using PRINT. What makes this an improvement over standard formulations are particularly important when considering PAH. PAH is chronic and progressive, part of a narrowing of the arteries in the lungs. This results in the right side of the heart having to pump harder, and eventually, it has difficulties keeping up. In the earlier stages of the disease, patients typically receive oral therapies. Fowler says, “Given the fact the disease progresses, oral medicines can’t keep up because of needing higher and higher doses. There’s a need at that point to deliver higher doses of these therapies, which is where pulmonary delivery comes into play. Eventually, in the later stages, patients require parenteral delivery. Where we’re involved is the pulmonary stage.”
The two drugs approved in the U.S. for pulmonary delivery in PAH have to be delivered by nebulizers, which can be cumbersome, require assembly, cleaning and a power source. Patients need to carry the nebulizers around with them in a bag to be used several times a day.
Fowler says, “Our 861 product is unique in it gets around the nebulizer. Patients have a dry-powder inhaler they can hold in their hand. In addition to convenience, our Phase I study also showed the ability to dose treprostinil higher than current therapies that are nebulized. We think the rationale is back to our PRINT particles, which are engineered to deliver the drug optimally into the deep lung while avoiding the off-target toxicities we see with drugs going places we don’t want them to go.”
The Phase III trial, which is ongoing, will have a readout for a safety endpoint in the first half of 2019. Assuming it is successful, it will be the basis of the company’s New Drug Application (NDA) to the FDA by the end of 2019.
The company’s other product is LIQ865, an injectable, sustained-release formulation of bupivacaine to manage local post-operative pain. It is formulated using PRINT. One of the interesting things about it is that it provides pain relief for 3 to 5 days. Fowler says, “The key is duration of effect—the drug has been around for years—and with our PRINT technology we’re able to create a release of the drug that provides benefit for the patient over 3 to 5 days. We have completed both Phase Ia and Ib studies. Not only is there a need for post-operative pain relief for that time, but with the opioid crisis, what we’re enabling is heading off the need for opioid use upstream. There is a subset of surgical patients that will, unfortunately, become addicted to opioids post-op, and by providing pain relief for 3 to 5 days post-operatively, it could stem the tide of that addiction.”
Liquidia expects to complete enabling toxicology work and to have a Phase II-ready application in 2019.
When asked about whether the PRINT process was only used to reformulate existing drugs, Fowler says no, and points out that Liquidia has a number of big pharma collaborators that are using it for new molecular entities. And, one of those most noteworthy collaborations is with GlaxoSmithKline.
“We entered into a research collaboration with GSK in 2012,” Fowler says. GSK took an exclusive license for the use of PRINT for pulmonary delivery in 2015. “The carve-out rights to pulmonary hypertension were maintained by us because we had done some preliminary work there and wanted to retain those right in that field.”
Furthermore, GSK is an equity holder in Liquidia and was a participant in the IPO. “That’s been a very good relationship for us and one we look forward to continuing in the future,” Fowler says.
And understandably, there’s quite a bit of excitement within the company over the way the IPO and its products are coming together. Kevin Gordon notes, “Right now the shares are trading very much in line with the opening prices, right around $11. We did succeed on the offering, which had a target of $50 million. It was expected to go out from $10 to $12 per share. We set the price at the midpoint of the range.”
The funds raised will be used to continue with the 861 and 865 programs. Fowler says, “It’s a clear validation about what we’ve been working on with our PRINT technology over the last few years and lays the groundwork for us to continue forward with our programs. But we’re most excited about what it does for patients. We are very poised and excited about the months ahead.”
