Traders News Source Senior Editor Mark Roberts Interviews Jennifer Good CEO at Trevi Therapeutics, Inc. (NASDAQ: TRVI)

Traders News Source Senior Editor Mark Roberts Interviews Jennifer Good CEO at Trevi Therapeutics, Inc. (NASDAQ: TRVI)

Traders News Source Senior Editor Mark Roberts Interviews Jennifer Good CEO at Trevi Therapeutics (NASDAQ: TRVI)

Thank you giving us your time to answer our questions.

Jennifer Good CEO and co-founder of Trevi Therapeutics 

Ms Good has served as a member of the Trevi board of directors and as the President and Chief Executive Officer since inception in March 2011. Previously, Ms. Good served at Penwest Pharmaceuticals Co., or Penwest, from 1997 to 2010, where she held various positions including President and Chief Executive Officer, Chief Operating Officer and Chief Financial Officer. Ms. Good has served on the board of Rhythm Pharmaceuticals, a publicly-traded biopharmaceutical company, since June 2019. Previously, Ms. Good served on the board of Juniper Pharmaceuticals, Inc., a publicly traded healthcare company, from September 2017 until it was acquired by Catalent, Inc. in August 2018. Ms. Good has also served as a board member of the Friedreich’s Ataxia Research Alliance (FARA), a patient advocacy group advancing treatments for the cure of Friedreich’s Ataxia, since 2011. Ms. Good received a Bachelor of Business Administration degree with a concentration in accounting from Pacific Lutheran University in 1987 and is a Certified Public Accountant licensed by the State of Washington, although her license is currently inactive.


Full Interview with Mark Roberts and Jennifer Good


For our readers who are not PhDs, what is nalbuphine ER?

Haduvio™, an investigational therapy, is an oral extended-release (ER) formulation of nalbuphine. Nalbuphine ER has a dual acting mechanism of action (MOA). This means it does two things to the body at the same time. It agonizes (or activates) ĸ-opioid receptors while also antagonizing (or blocking) the µ-opioid receptors.  The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough, and certain movement disorders. It has been approved and marketed as an injectable for short-term moderate to severe pain indications for more than 20 years in the United States and Europe.

TRVI recently announced encouraging data from its PRISM trial for Haduvio. What is PN and can you describe the remainder of that study with timelines?

Prurigo nodularis is a serious, potentially debilitating, chronic dermatologic skin condition that currently has no approved therapies. There are ~300k patients in the US and ~730k worldwide. This disease is characterized by intense itching with raised nodular lesions, plaques, and papules that are usually distributed symmetrically on the body.

We are thrilled to have recently announced the positive data from our Ph2b/3 Pruritus Relief through Itch Scratch Modulation (PRISM) trial which demonstrated that 25% of Haduvio-treated subjects achieved a 4-point reduction in worst itch NRS after 14 weeks of treatment compared to 14% of placebo-treated subjects (p=0.0157). We are the only oral therapy to have seen positive results in this indication and look forward to analyzing this data further as patients complete the open-label extension portion of the study and determining the next steps for the program.

Would you briefly describe the CANAL study Haduvio was involved in and describe IPF?

The Ph2 Cough And NALbuphine (CANAL) trial studied the treatment of cough in those suffering from idiopathic pulmonary fibrosis (IPF). Up to 85% of IPF patients experience chronic cough and ~130k IPF patients are in the US. This cough can impact patients both physically (causing breathlessness, fatigue, and air hunger) as well as mentally (anxiety and feelings of isolation by limiting acts that might cause a coughing fit like walking or talking). This cough can occur up to 1,500 times a day and may contribute to disease worsening. As IPF is an end-of-life disease, there is a high priority to improve the quality of life for these patients.

We were very happy to achieve such a positive and significant result from the CANAL trial during our interim efficacy analysis. After 22 days of treatment, Nalbuphine ER was found to reduce daytime cough frequency by 77%, that’s 52% more than placebo (p<0.0001). In addition, 42% of the nalbuphine ER treated subjects achieved a ≥ 75% reduction from the study baseline in daytime cough frequency, as compared to 0% of subjects in the placebo arm.  Due to the very compelling data in this interim analysis, we ended the study early and have accelerated into the next phase of development for this indication.

What other indications is Trevi studying using Haduvio as a treatment?

We are not currently investigating the use of Haduvio in other indications as we focus on reading out data from the full set of subjects in the CANAL trial this quarter and further analyzing the remainder of the PN data.  Once we get all the data and meet with regulatory authorities, we will make decisions about other indications.

What is your perspective on the potential market(s) for Haduvio and what might the total addressable market be?

What is exciting about our current trials is that positive results from both these indications demonstrate the potential to help patients experiencing chronic itch and cough. Since our MOA is targeting the signaling in the body to respond with an itch and/or cough respectively, we feel we have the potential to work across a broad array of indications that suffer from these ailments with high unmet needs. The global chronic cough market is estimated at ~$10B and the global pruritus market is estimated at ~$20B so there is a lot of potential.

What were your company’s biggest accomplishments in the last year?

We have had an incredible last few months with both of our lead trials reading out statistically significant results. Both chronic cough in IPF and prurigo nodularis are unmet needs and we are happy that we could see potential relief for these patients based on our results.

Trevi seems to have a strong cash position. How far into the future will your current cash level fund the company?

We closed $55 million equity financing in April of this year on the heels of our positive CANAL interim analysis. This financing was done at market with good long-term shareholders in a tough financing environment for biotech.  This allows us to continue to aggressively develop our indications.  The last cash runway guidance we provided at the end of the first quarter is that we expect our current cash to get us to the first quarter of 2024.

What do you think is the biggest strength of TVRI? What does your company do well?

Our company has made meaningful progress this year and I think it can be attributed to some of our strengths:  1) Our company is focused on one asset which has now read out two positive trials in both of our indications and validates the hypothesis of the potentially broad utility of the drug 2) Haduvio is an oral extended-release formulation which has the potential to be a first in class oral therapy for both of these indications and an ability to expand to other cough and pruritus indications 3) We have a strong team at Trevi which has a history of success and has been instrumental in moving us forward 4) We have a strong balance sheet and a clear path ahead which allows us to stay focused on what we do well and not worry about the state of the capital markets.

We appreciate your time Jennifer.

The Traders News Group


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