Can Trevi get through IPO window with old opioid that failed key Phase 2?

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?

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).

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.

https://endpts.com/can-trevi-make-it-through-the-ipo-window-with-an-old-opioid-that-failed-their-key-phii/