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
***The owners and operators of this website have NOT been compensated in any way for conducting or distributing this interview. Furthermore, we do not hold any form of equity in the publicly traded company/companies mentioned above***
Privacy Policy and Disclaimer
Your Consent
By using our site, you consent to our online privacy policy and disclaimer.
Do we disclose any information to outside parties?
We do not sell your information to anyone.
What information do we collect?
We collect information from you when you subscribe to our newsletter or fill out a form on one of our social platforms. This includes your email address and or mobile phone number.
When registering on our site, as appropriate, you may be asked to enter your: e-mail address and or mobile number.
What do we use your information for?
When we collect your email or mobile number it is used for one purpose to send you the information you requested about small cap stocks. Please read our disclaimer carefully before viewing our emails.
Your information, whether public or private, will not be sold, exchanged, transferred, or given to any other company for any reason whatsoever, other than for the express purpose of delivering the information on small cap stocks that you requested.
We send periodic emails
The email address you provide may be used to send you information, the small cap stock reports you requested, respond to inquiries, and/or other requests or questions.
How do we protect your information?
We implement a variety of security measures to maintain the safety of your personal information when you enter, submit, your email address. We use secure third parties to send email and sms messages to you.
Because we value your privacy we have taken the necessary precautions to be in compliance with the California Online Privacy Protection Act.
Online Privacy Policy Policy
This online privacy policy applies to information collected through our website and social media platforms.
Contacting Us
If there are any questions regarding this privacy policy or disclaimer you may contact us using the information below.
Editor@TradersNewsSource.com
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
Please Note: TNS LLC and its employees are not a registered investment advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operators owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D. TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results.
In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.
TNS LLC is not affiliated with any exchange, electronic quotation system, the Securities Exchange Commission or FINRA. TNS LLC is not a Broker/Dealer and does not engage in high frequency trading.
