<SEC-DOCUMENT>0000000000-18-038479.txt : 20190605
<SEC-HEADER>0000000000-18-038479.hdr.sgml : 20190605
<ACCEPTANCE-DATETIME>20181218170818
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-18-038479
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20181218

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Trevi Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001563880
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				450834299
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		195 CHURCH STREET
		STREET 2:		14TH FLOOR
		CITY:			NEW HAVEN
		STATE:			CT
		ZIP:			06510
		BUSINESS PHONE:		203-304-2499

	MAIL ADDRESS:	
		STREET 1:		195 CHURCH STREET
		STREET 2:		14TH FLOOR
		CITY:			NEW HAVEN
		STATE:			CT
		ZIP:			06510
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
                                                            December 18, 2018

Jennifer L. Good
President and Chief Executive Officer
Trevi Therapeutics, Inc.
195 Church Street, 14th Floor
New Haven, CT 06510

       Re: Trevi Therapeutics, Inc.
           Draft Registration Statement on Form S-1
           Submitted November 19, 2018
           CIK No. 0001563880

Dear Ms. Good:

       We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so we may
better
understand your disclosure.

       Please respond to this letter by providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances
or do not
believe an amendment is appropriate, please tell us why in your response.

      After reviewing the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.

Draft Registration Statement on Form S-1 submitted on November 19, 2018

Prospectus Summary
Overview, page 1

1.     We note your disclosure on page 3 and elsewhere that you will need to
conduct an
       additional Phase 3 trial to support a new drug application for
nalbuphine ER for the
       treatment of prurigo nodularis. Please remove references here and
throughout your
       registration statement, including in your pipeline development chart, to
your ongoing
       Phase 2b/3 PRISM trial as "pivotal" as this characterization is
premature and
       inappropriate for you to make.
 Jennifer L. Good
FirstName LastNameJennifer L. Good
Trevi Therapeutics, Inc.
Comapany18, 2018
December NameTrevi Therapeutics, Inc.
December 18, 2018 Page 2
Page 2
FirstName LastName
2.       Please remove from your pipeline development chart the clinical
program for uremic
         pruritus as you are not actively developing nalbuphine ER for this
indication, as stated on
         page 3. Please also amend your disclosure to shorten the arrows
corresponding to "Other
         Neurobiologically Mediated Conditions" to denote that you have not yet
commenced
         Phase 2 clinical trials. To the extent the dotted lines are intended
to denote that the trials
         have not started, please revise to make this clear. Additionally, we
note your disclosure on
         page 96 that you intend to initiate a Phase 2a clinical trial to
evaluate the safety of
         nalbuphine ER in patients with IPF. Please add disclosure to the chart
to make it clear that
         the purpose of the Phase 2a trial will be to evaluate safety.
Our Strengths, page 3

3.       Please revise your disclosure to make it clear that you are not
actively developing
         nalbuphine ER for the treatment of uremic pruritis or remove the
reference to "two serious
         chronic pruritis indications" and the statement that nalbuphine ER has
demonstrated
         statistically significant improvements in patients with uremic
pruritus. Additionally,
         please expand your disclosure to indicate that your observations to
date for the treatment
         of prurigo nodularis are based in part on post hoc analyses due to the
limited number of
         patients who completed treatment in your Phase 2 trial, as discussed
on page 93.
4.       Given that you have one product candidate in development, please tell
us why you believe
         it is appropriate to state that you have a "broad" clinical pipeline.
Alternatively, please
         remove this disclosure.
5.       We note your disclosure that nalbuphine has an established efficacy
and safety profile,
         and that nalbuphine has been shown to be well-tolerated with a
favorable safety profile.
         You further state that nalbuphine's mechanism of action mitigates the
risk of abuse
         associated with  -opioid agonists because it blocks the  -opioid
receptor. Please place this
         selected disclosure in its full and proper context by expanding your
disclosure to discuss
         the following:

             your planned human abuse liability (HAL) study, as discussed on
page 21;
             the risk of psychiatric side effects associated with k-opioid
receptor agonists, as
             referenced on page 20; and
             the risk of withdrawal effects, respiratory depression, cardiac
and endocrine side
             effects.
6.       Please balance your disclosure in this section with a discussion of
the challenges you face
         in successfully commercializing nalbuphine ER, such as labeling and
distribution
         restrictions applicable to similar drugs, as discussed on page 20, and
regulatory risk that
         your sole product candidate may be classified as a controlled
substance, as discussed on
         page 21.
 Jennifer L. Good
FirstName LastNameJennifer L. Good
Trevi Therapeutics, Inc.
Comapany18, 2018
December NameTrevi Therapeutics, Inc.
December 18, 2018 Page 3
Page 3
FirstName LastName
Risks Associated with our Business, page 5

7.       Please expand your disclosure in the eighth bullet point to discuss
the difficulties you may
         face in recruiting and retaining sufficient patients in your clinical
trials, as discussed on
         page 18. Additionally, please expand your disclosure to state that you
do not own or
         exclusively license any composition of matters patents for your sole
product candidate.
Implications of Being an Emerging Growth Company, page 6

8.       Please supplementally provide us with copies of all written
communications, as defined in
         Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
         present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
         not they retain copies of the communications.

Risk Factors
Our certificate of incorporation will provide that the Court of Chancery of the
State of Delaware
will be the exclusive forum...., page 62

9.       We note that your forum selection provision identifies the Court of
Chancery of the State
         of Delaware as the exclusive forum for certain litigation, including
any "derivative action"
         and federal district courts for any claims arising under the
Securities Act of 1933, as
         amended. Please disclose whether this provision applies to actions
arising under the
         Securities Exchange Act of 1934, as amended. Also ensure that the
exclusive forum
         provision in your proposed organizational documents states this
clearly. In this regard, we
         note that Section 27 of the Exchange Act creates exclusive federal
jurisdiction over all
         suits brought to enforce any duty or liability created by the Exchange
Act or the rules and
         regulations thereunder.
Use of Proceeds, page 66

10.      It appears from your disclosure that the proceeds from the offering
will not be sufficient to
         fund development of nalbuphine ER through regulatory approval and
commercialization.
         Please indicate how far the proceeds from the offering will allow you
to proceed with the
         continued development of your product candidate, and disclose the
sources of other funds
         needed to reach regulatory approval and commercialization for
nalbuphine ER. Refer to
         Instruction 3 to Item 504 of Regulation S-K.


11.      Please revise the second bullet point to specify the indications that
comprise the "other
         serious neurologically mediated conditions" you mention here and the
amount(s) to be
         allocated to each indication.
 Jennifer L. Good
FirstName LastNameJennifer L. Good
Trevi Therapeutics, Inc.
Comapany18, 2018
December NameTrevi Therapeutics, Inc.
December 18, 2018 Page 4
Page 4
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations
Operating Expenses
Research and Development Expenses, page 78

12.      You indicate on page 76 that all of your research and development
expenses consist of
         expenses incurred in connection with the development of nalbuphine ER.
You also
         indicate therein that you do not allocate costs by each indication for
which you are
         developing nalbuphine ER. Please consider quantifying in a table for
each period
         presented the amount of costs incurred for internal costs versus
external costs and
         providing further breakout of those types of costs. For example,
further breakout for
         internal costs could include by nature(i.e. certain payroll and
personnel costs, stock-based
         compensation) and a breakout for external costs could include costs
incurred by indication
         or, if not available, by nature (i.e. consulting costs, contract
manufacturing costs and fees
         paid to clinical research organizations).
Critical Accounting Policies and Use of Estimates
Stock-Based Compensation Expense
Common Stock Valuations, page 86

13.      Once you have an estimated offering price or range, please explain to
us how you
         determined the fair value of the common stock underlying your equity
issuances and the
         reasons any differences between the recent valuations of your common
stock leading up
         to the IPO and the estimated offering price. This information will
help facilitate our
         review of your accounting for equity issuances including stock
compensation and
         beneficial conversion features.
Business
Nalbuphine ER, page 98

14.      As you have not yet secured marketing approval for nalbuphine ER, it
is inappropriate for
         you to state your conclusion that the established efficacy and safety
profile of nalbuphine
         and clinical results to date indicate a "favorable safety and
tolerability profile." The
         determination whether a product candidate is safe is within the sole
authority of the U.S.
         Food and Drug Administration and comparable regulatory bodies and is
based on results
         observed in all phases of clinical trials. Therefore, please revise
your disclosure to remove
         this statement.
Prurigo Nodularis Program
Phase 2 Clinical Trial
Safety Results, page 102

15.      We note your disclosure that no serious adverse events (SAEs) in your
Phase 2 trial were
         assessed as definitely, probably or possibly related to nalbuphine ER.
Please expand your
 Jennifer L. Good
Trevi Therapeutics, Inc.
December 18, 2018
Page 5
       disclosure to include all SAEs, irrespective of whether the investigator
determined such
       SAEs were treatment-related. Add similar disclosure where you discuss
the safety results
       of your Phase 2b/3 clinical trial for the treatment of uremic pruritus
on page 107.
General

16.    Please provide us proofs of all graphics, visual, or photographic
information you will
       provide in the printed prospectus prior to its use, for example in a
preliminary prospectus.
       Please note that we may have comments regarding this material.



       You may contact Keira Nakada at 202-551-3659 or Jim Rosenberg at
202-551-3679 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Christine Westbrook at 202-551-5019 or Mary Beth Breslin at
202-551-3625 with any
other questions.



                                                             Sincerely,
FirstName LastNameJennifer L. Good
                                                             Division of
Corporation Finance
Comapany NameTrevi Therapeutics, Inc.
                                                             Office of
Healthcare & Insurance
December 18, 2018 Page 5
cc:       Stuart M. Falber, Esq.
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
