Can Tre­vi make it through the IPO win­dow with an old opi­oid that failed their key PhII?

The win­dow for biotech IPOs may still be open, but is it open wide enough to ac­com­mo­date Tre­vi Ther­a­peu­tics, with a failed Phase II study for an ex­tend­ed-re­lease ver­sion of an old opi­oid pain rem­e­dy? 

Jen­nifer Good

Tre­vi filed for an $86 mil­lion IPO over the week­end. In it, they ap­par­ent­ly re­vealed for the first time that their drug, nal­buphine ER, failed bad­ly in a mid-stage study that re­cruit­ed 63 pa­tients and test­ed it at 2 dos­es com­pared to a place­bo. 

Based on a post hoc analy­sis, which teased out more promis­ing re­sults by ex­clud­ing the pa­tients who had dropped out of the study, the biotech is nev­er­the­less un­der­tak­ing a Phase IIb/III clin­i­cal tri­al in ure­mic pru­ri­tus, with 373 pa­tients to be en­rolled with a mod­er­ate to se­vere case of the dis­ease.

Here’s their sum­ma­ry of the da­ta:

In the 162 mg arm, pa­tients re­port­ed a mean 2.51 point re­duc­tion in WI-NRS score from base­line as com­pared with a mean 1.75 point re­duc­tion in the place­bo arm (p=0.083), with 44% of the pa­tients in the 162 mg arm con­sti­tut­ing re­spon­ders as com­pared to 36% of the pa­tients in the place­bo arm (p=0.323). In the 81 mg arm, pa­tients re­port­ed a mean 2.14 point re­duc­tion in WI-NRS score from base­line, with 27% of the pa­tients in the arm con­sti­tut­ing re­spon­ders (p=0.779). A key sec­ondary end­point of the tri­al was the pro­por­tion of pa­tients re­port­ing at least a 50% re­duc­tion in WI-NRS score from base­line. In the 162 mg arm, 33% of pa­tients re­port­ed at least a 50% re­duc­tion in WI-NRS score as com­pared to 18% of pa­tients in the place­bo arm (p=0.083).

David Meek­er

That’s not good. But there was a pos­i­tive sec­ondary on qual­i­ty of life. The on­ly men­tion we could find of a Phase II on Tre­vi’s web­page dates back to 2016, which they said was pos­i­tive. 

This is the New Haven-based biotech’s on­ly drug, which they are test­ing for a va­ri­ety of con­di­tions.

We read on Wikipedia that nal­buphine is the on­ly opi­oid that is not mar­ket­ed as a con­trolled sub­stance. Ap­proved 41 years ago, it’s been gener­ic for decades now.

Tre­vi is go­ing in­to the at­tempt­ed IPO with­out the big bucks we’re used to see­ing. The biotech end­ed 2018 with $7.2 mil­lion in the back, then soon af­ter raised $10 mil­lion in a Se­ries C sale of stock. The com­pa­ny has raised $92 mil­lion from the sale of shares and notes and al­so ob­tained a $15 mil­lion loan, which has been paid back.

TPG is the big backer here, with 55% of the stock. NEA fol­lows at 20% with Lund­beck­fond In­vest in at 8% and Omega Fund in at 6.2%. CEO Jen­nifer Good has 4.3% of the shares while Chair­man David Meek­er — ex-Gen­zyme chief and biotech CEO — has a 3.9% stake in the com­pa­ny.

John Hood [file photo]

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

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On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

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Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

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Abeliovich and Prevail, though, aren’t taking this one lying down.

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CEO Pascal Soriot via Getty Images

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

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