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n e w h a v e n b i z . c o m | S e p t e m b e r / O c t o b e r 2 0 1 9 | n e w h a v e n B I Z 23 INNOVATION & ENTREPRENEURSHIP body's different systems. at led Good to start thinking about non- pain indications that a drug could make a difference with. "Using it to treat the skin and itchiness made a lot of sense," she explains. "So did coughing in idiopathic pulmonary fibrosis. And also different movement disorders, specifically Parkinson's. We thought about severe conditions, things that are very debilitating to people. at was really the genesis of what got us going." e way Good explains it is this: "e human body is regulated through the central and peripheral nervous system," she says. "When you have chronic pain — whether it's from cancer, back problems, osteoarthritis — that all works centrally in the brain and it doesn't matter what the underlying disease state is. e medication goes to the brain and basically activates the reward center to say, No — you're not in pain." I n its injectable form, nalbuphine has a long history of efficacy and safety. It's been approved for more than 20 years in the U.S. and Europe for relief of moderate to severe pain in the hospital setting, and is currently the only opioid that is not classified as a controlled substance by the U.S. Food & Drug Administration (FDA). e oral, extended release version of nalbuphine that extends the plasma half-life from under two hours to nine hours, enabling twice-daily oral dosing and opening up its potential use in patients with a variety of serious symptoms caused by many chronic neurologically mediated conditions. Good believes it will be quite effective for people with idiopathic pulmonary fibrosis, a disease that affects primarily older adults. "It's a disease of aging," Good explains. "It's progressive, and eventually they die — many within three to five years." "About 85 percent of those with the disease cough," explains Good. "It's interesting, they cough all during the day, but they lay down at night and it stops, which is sort of vintage neurological thing. When the neurological signals settle down, they stop the coughing, because the coughing's serving no role," she explains. "Your lungs feel fibrotic, and they're sending the signal to the brain saying something's wrong, and you cough, trying to get air. And so when you think about that pathway, both the lungs, the peripheral nerves to the lungs, to the spinal cord, and your brain are all involved in that coughing reflex, and they're all rich in these receptors. And so we're trying to intervene all along that pathway." Nalbuphine is in the second phase of development for cough and chronic kidney disease. Its lead indication is in a severe skin condition called prurigo nodu- laris, which is in Phase III testing, the final phase. Trevi has completed clinical trials in two conditions: pruritus associated with prurigo nodularis, and uremic pruritus. More than 400 patients were treated with different doses of nalbuphine ER, generating positive results in difficult-to-treat conditions, and demonstrating a favorable long- term safety profile. "at first trial will read out first half of next year," Good says. "Assuming that's successful, then we'll need to run one more trial. e cough program's in Phase II. So if that goes well, then we'll move into Phase III. So we're getting into late-stage development around our pipeline. ere are no approved therapies in the U.S. or Europe, so this is pioneering." Aer the final phase is complete, Trevi will file a new drug application with the FDA in the U.S. as well as with regulators in Europe. Once all is approved, the drug launch would take place in 2023. "is is definitely not a short business model that we're in," Good says. "It takes time." Once development and approval is complete, Good plans to keep serving the patient groups Trevi is in. "We can either take the drug we have into different indications, we think it has broad utility, or we can look to bring in other molecules and serve some of the patient groups that we're already in." ' T h i s i s d e f i n i t e l y n o t a s h o r t b u s i n e s s m o d e l t h a t w e'r e i n . I t t a k e s t i m e . ' A long with serving as Trevi's co-founder, member of our board of directors and as president and chief executive officer, Good also serves on the board of Rhythm Pharmaceuticals Inc., a publicly traded rare disease company headquartered in Boston. She also chairs its compensation committee. Good also serves as a board member of the Friedreich's Ataxia Research Alliance, a patient advocacy group advancing treatments for the cure of Friedreich's Ataxia. And in her spare time, she likes to give back to her community and volunteers as treasurer for the Newtown Youth and Family Services, which provides mental health services and programs to support the community. "Mental health, I think, is a big issue and that's part of why I joined that board," Good says. "I thought it was a good place to reinvest back in my local community." n

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