Enrollment for Trevena’s COVID-19 treatment trial, part of the National Institutes of Health’s (NIH's) ACTIV-4 program, has ceased after the program’s data safety monitoring board found the company’s med reached an “inferiority stopping criterion.”
The company was notified Friday that trial enrollment for the drug, TRV027, which was being developed as part of the host tissue platform of the ACTIV-4 program, should cease and that the study should be discontinued, according to a disclosure Monday. The company said its program was included among “certain trials” the data safety monitoring board identified.
A spokesperson for the National Heart, Lung, and Blood Institute, which is overseeing the trials, said the additional study that ceased enrollment was for Constant Therapeutics' TXA127, which looks to reinfuse the body with the peptide angiotensin-(1-7). The agency said that enrolment has therefore been halted.
TRV027 was an AT1 receptor selective agonist meant to treat acute respiratory distress syndrome and abnormal clotting as a result of COVID-19. The trial was part of the host tissue segment of ACTIV-4 meant to identify new therapies for hospitalized COVID patients and was run out of the Vanderbilt University Medical Center. Neither Trevena nor Vanderbilt responded to requests for comment.
The host tissue arm of ACTIV-4 was one of four different platforms assessing blood thinners to treat COVID-19. The NIH indicated the objective was to assess effectiveness at preventing “a cascade of potentially life-threatening complications such as blood vessel damage, lung damage, blood clots and heart injury.”
Included in Trevena and Constant's arm was Rigel Pharmaceutical's FDA-approved Tavalisse, a treatment for chronic immune thrombocytopenia. According to the NIH’s website, all three trials in the program are still listed as “continuing enrollment.”
For Trevena, it’s a clear setback for an asset that’s now furthest along in the company's pipeline after Olinvyk was approved in August 2020 for treatment of acute pain severe enough to require intravenous opioid analgesic.
The enrollment halts are even more telling for the federal government’s efforts to spearhead the development of new COVID treatments. Over the last couple of months, a couple of other ACTIV-backed treatment trails were shuttered due to low COVID hospitalizations.
However, all has not been lost, as some government-backed treatments have been able to progress. Shionogi announced last month that its COVID treatment would be moving on to a government-backed phase 3 trial after finalizing a study design.
Editor's note: This story was updated at 10 a.m. ET on April 26, 2022, to include a statement and additional details from the National Heart, Lung, and Blood Institute under NIH.