Trevi to expand enrollment in clinical trial for chronic itching treatment

New Haven’s Trevi Therapeutics said Monday that it will expand enrollment in a clinical trial of its drug to treat chronic itching in patients with the skin condition prurigo nodularis.

It has also settled on a trade name for the drug: Haduvio (generic: nalbuphine ER).

Trevi said an independent data monitoring committee recommended expanding the enrollment target for the study from 240 to 360. 

The decision came after a midway assessment of 45 percent of the targeted 240 volunteers found that the drug was working but needed a larger sample size to demonstrate the effect, Trevi said. 

President and CEO Jennifer L. Good said the recommendation “further reinforces our view that Haduvio may be an effective treatment option for patients with PN.”

She said Trevi has increased the number of active trial sites to 60 globally and enrollment has “been picking up nicely since the removal of most COVID-19 screening and enrollment restrictions.”

Trevi’s drug is an oral, extended-release version of an injectable pain medication that has been marketed for 20 years in the U.S. and UK. 

It is the only opioid not classified as a controlled substance by the FDA, Trevi said, offering the pain-relieving benefits of an opioid with little risk of addiction.

The company expects to complete enrollment during the third quarter of 2021 and report top-line data by the end of next year.  

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Cybrexa Therapeutics said it received positive feedback during a meeting with the U.S. Food & Drug Administration on a potential investigational new drug (IND) application for its anti-tumor drug CBX-12.

Cybrexa said the successful FDA meeting puts it on track to file the application later this year and begin human trials during the first half of 2021.

The drug uses Cybrexa’s alphalex technology, which deposits cancer-fighting agents directly into tumor cells while sparing healthy tissue, combined with a potent cancer drug known as topoisomerase I inhibitor.

The Phase 1 portion of the trial will establish a safety profile and recommended dose and the Phase 2 trial will test its effectiveness across a number of solid tumors, Cybrexa said.

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New Haven’s BioXcel Therapeutics has secured a U.S. patent for its agitation drug BXCL501. The patent covers BioXcel’s thin-film formulation of dexmedetomidine (Dex), an older Pfizer drug, and its methods of treating agitation using such film formulations, BioXcel said. 

The patent would be issued by the end of September and expire no earlier than 2039.

BioXcel’s thin-film version tastes minty and is similar to a mouthwash strip. It dissolves under a patient’s tongue. 

BioXcel is testing the drug in separate trials to treat agitation in patients suffering from dementia, bipolar disorder, schizophrenia and opioid use withdrawal.