Trevana CEO says the biopharma is ‘rapidly’ moving its oliceridine painkiller program forward

Trevena Inc (NASDAQ:TRVN) CEO Carrie L Bourdow said Wednesday that the company is rapidly moving its oliceridine painkiller program forward and has submitted the protocol for the previously announced healthy volunteer study of oliceridine to the Food and Drug Administration.

The biopharma is conducting the study in healthy volunteers to collect the requested QT interval data for oliceridine.

Oliceridine, given the brand name Olinvo, works differently than conventional opioids, the company says. It uses a different pathway to relieve pain without causing respiratory and gastrointestinal side effects that limit other pain meds.

READ: Trevena shares rise after dose of good news from FDA about pain drug

In the end of January, the FDA agreed that its safety database will support the labeling for its painkiller oliceridine at a maximum daily dose of 27 mg.

The Chesterbrook, Pennsylvania-based company has submitted a detailed protocol and analysis plan to the FDA following receipt of regulators’ feedback. It hopes to kick off a study in the first half of this year, following receipt of feedback from the FDA.

“Following our successful Type A meeting with the FDA, we have continued to rapidly move the oliceridine program forward,” Bourdow said in a statement. “We have submitted the protocol for the previously announced healthy volunteer study of oliceridine and anticipate commencing this study in the first half of 2019.”

Financial outlook

As of the end of December 2018, the company was sitting on cash and cash equivalents of $61.5 million, which is sufficient to fund its operating expenses and capital spending into the third quarter of 2020, according to the company’s management.

In January, the company raised $9.2 million through a direct stock offering enabling the company to extend its cash runway into the third quarter of 2020.

For the fourth quarter of 2018, the company reported a net loss of $8 million, or $0.10 per share, compared with a $14.7 million loss, or $0.24 per share, for the fourth quarter of 2017. 

For 2018, net loss stood at $30.8 million, or $0.42 per share, compared to $71.9 million, or $1.21 per share, for the year ended December 31, 2017.  

“This decrease is primarily due to the recognition in 2018 of collaboration revenue associated with the licensing agreements for oliceridine, and to substantially lower research and development expenses,” said the company.

Trevena shares were recently down 2.7% to $1.43 in morning trading.

Busy pipeline

Trevena is a biopharmaceutical company focused on the development and commercialization of treatments for patients in pain. The company’s drug candidates also include TRV250 for the treatment of acute migraines, and TRV734 for pain and the management of opioid dependence.

“In addition to oliceridine, we have achieved meaningful milestones with our early-stage pipeline assets and, in 2019, expect to continue the development of these assets to build long-term stockholder value,” said Bourdow.

In 2018, the company completed a Phase 1 trial for TRV250, a potential new way of treating acute migraines. It also struck a partnership with the National Institute on Drug Abuse (NIDA) for TRV734 in the management of opioid use disorder.

In its S1P receptor program, the company said Wednesday that it has identified a lead candidate designated as TRV045. This candidate holds promise as a non-opioid treatment of chronic pain and other central nervous system conditions.   

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors