The founding idea of a startup isn’t always the one that sticks. In the case of Madison-based Plumb Pharmaceuticals, the original intent was to develop a long-term pain management treatment for animals.
About 10 years later, Plumb is now looking at federal Food and Drug Administration approval for a drug delivery method that will help humans battling opioid addiction.
Founders Timothy Heath and Lisa Krugner-Higby have created a formula of liposomes that, when loaded with medication and injected under the skin, slowly releases medications. Plumb is currently loading the liposomes with naltrexone or buprenorphine — which curb cravings and block opioid receptors — but Heath and Krugner-Higby believe other medications, such as those for mental health conditions, can also be delivered through this process.
CEO Jacqueline Hind, who previously worked at startup Swallow Solutions and was brought on to manage timelines and fundraising for Plumb, said the growing opioid crisis in the U.S. was a central reason for the shift to a human-application of the method. Opioid addicts are most likely to relapse at the end of their medication cycle, she said, just before they go back for another injection.
“When they are kind of at that crossroads, they’re having to make that decision, ‘Should I take my medication or should I take an opiate?’” Hind said. “What our technology would do is put people effectively at that crossroads — instead of everyday or every month — just three to four times a year.”
Liposomes have been used for extended-release drugs for years, Heath said, but the release span for those currently on the market is typically a month. Plumb’s patented method, called Advanced Quantload Technology, has been shown in animal tests to extend that release time to three months.
“What we’re doing, nobody is able to do,” Hind said.
Plumb Pharmaceuticals was founded in 2011 under the name Comfort Care for Animals, but through the course of research and development and with guidance from some area business leaders, the founders shifted to creating a human application for their innovation in 2016.
Founders Heath and Krugner-Higby have decades of experience in liposomal technology and veterinary science respectively.
Heath earned a doctorate in 1976 and was a researcher at the UW-Madison School of Pharmacy from 1985 until his retirement in 2007.
Krugner-Higby earned her doctorate of veterinary medicine in 1986 and a Ph.D. in cellular and molecular pathobiology in 1992. She began working at the UW-Madison Research Animal Resource and Compliance center in 1995 and is still a researcher there.
“In the academic sector, there’s a certain point where research has a practical application,” Heath said. “I suppose you could say we just followed our work from its infancy as a kind of conceptual idea to something that may actually do something in the everyday world.”
Heath said his retirement in 2007 was a catalyst for Plumb’s research, in part because he had time to “stare at the wall for a few years” and think about what could be possible.
“There are things you don’t have time to do when you have a faculty member’s responsibility,” Heath said. “When you can really get away from that and start teasing through the ideas — and it takes years to do that kind of creative part of the process — it’s very powerful.”
Until now, Plumb has been raising money through friends, family and research grants, such as grants from the National Institutes of Health and the Small Business Innovation Research program. Hind said the company is now hoping to raise upwards of $8 million from angel and venture capital investors to help fund the FDA trials.
Plumb doesn’t intend to manufacture the drug delivery method, Hind said. Instead, the plan is to license the technology to a pharmaceutical company that would then bring it to market.
Plumb is on track to conduct human trials for Food and Drug Administration approval in 2021 with the possibility of licensing the method to a manufacturer in 2023, Hind said.
Because Plumb is developing a delivery method rather than a new drug in and of itself, Hind said the FDA approval process will likely be quicker.
“Hopefully we have the best of both worlds,” Krugner-Higby said. “We have a drug delivery system with an FDA approval history, and novel technology to use with that delivery system.”
Fave 5: Business reporter Shelley K. Mesch shares top stories from 2019
We are sharing Wisconsin State Journal staffers' favorite work from 2019. From business reporter Shelley Mesch: I spent the first half of 2019 covering Dane County government and rounded out the second half by joining the business desk, where I focus on technology and start-ups.
Exact Sciences -- one of the major Madison companies I get to keep an eye on -- has hundreds of job openings, and I learned about how the biotech company is teaming up with Urban League of Greater Madison to train potential employees.
Another business story that caught my interest came from area business leaders touting the region as a prime location for new startups. It made me wonder how well Wisconsin is stacking up to its Midwestern neighbors in venture capital investments.
Yet another question I found myself asking -- do you see a trend here in how I find my stories? -- was about the rising popularity of e-bikes, particularly after BCycle converted its fleet of short-term rentals to the pedal-assisted bikes. The story was an interesting one to report, and I’m not just saying that because it got me back on a bike for the first time in about 10 years.
A reporting excursion earlier in the year, when I was still reporting on Dane County, took me out to a landfill, where the county had just turned on a giant processing plant to clean the methane and other gases emitted from the mountains of trash. Those emissions are then sold as natural gas, which can even be used as a more environmentally friendly vehicle fuel. Luckily, when I toured the facility, the garbage didn’t even smell that bad.
One of the more challenging stories I wrote this year involved the county-owned Vilas Zoo, which decided in March that it could not reach an agreement with the Henry Vilas Zoological Society, the zoo’s fundraising arm for more than 100 years. My initial reporting led to more than a dozen more articles on the conflict and sparked county-wide conversations about what could have, would have and should have been done differently.
If you want to read my other stories, you can find them here.
Urban League's training program is designed specifically to prepare trainees for entry-level jobs at Exact Sciences, the biomedical powerhouse behind the at-home colon cancer screening test Cologuard.
“If we want to create the kinds of high-growth companies with high-paying employment, we need to have venture capital,” the head of one venture capital firm said.
"It was just like, 'Woo, that was cool,'" Jane Prell said of the first time she rode an e-bike. "You just want to scream with joy."
The county had long been trapping the methane and other gases emitted from the heaps of garbage at the landfill to be used for electricity, but the county is now using that resource to create and sell compressed natural gas (CNG), a more eco-friendly vehicle fuel than gasoline and diesel.
The Henry Vilas Zoological Society currently operates all of the zoo's concessions, the carousel and the train ride while managing fundraisers for the zoo, but all that will end March 31.
Starting Up features young area companies as they try to bring their big ideas to the world. Contact reporter Shelley K. Mesch at firstname.lastname@example.org or 608-252-6143 with suggestions.