- Positive top-line results from two pivotal, late-stage studies of Trevena's lead candidate weren't enough to convince investors of the drug's value, leading the clinical-stage pharma's stock to plummet early Tuesday.
- The studies tested Olinvo (oliceridine injection) as a moderate to severe pain medication in patients who received surgery for bunion removal or abdominoplasty. Trevena investigated three doses of the drug and found all outperformed placebo in pain relief and demonstrated better safety profiles than morphine.
- Analysts questioned that safety profile, however, particularly for patient populations less healthy than those participating in the APOLLO-1 and APOLLO-2 Phase 3 trials. A third late-stage study, named ATHENA-1, focused on developing a safety database for the drug is currently enrolling, and should support a New Drug Application (NDA) filing in the fourth quarter.
"In APOLLO, these patients are essentially healthy volunteers who are having surgery, and so the more fragile patients – patients with higher BMIs with multiple risk factors and so forth – will really come from the ATHENA data set," Trevena's Chief Medical Officer David Soergel said during a Feb. 21 call.
Though Trevena could not give out any information about the severity of side effects in the Phase 3 trials, it did note that two serious adverse events took place in APOLLO-2, with one patient demonstrating lethargy and another fainting.
The company added that, while it is open to conducting additional clinical trials after filing an NDA, it remained confident existing efficacy and safety results would push the drug through approval. Should Olinvo make it to market, Trevena's early predictions have daily treatments priced between $60 and $140, though that range could change.
After two days, the three doses of Olinvo — 0.1 mg, 0.35 mg, and 0.5 mg — significantly reduced pain versus placebo treatment, according to a Feb. 21 statement. Trevena's drug had efficacy similar to morphine, but with lower rates of respiratory burden, nausea and vomiting. The company plans to reveal additional data at later pain-related medical conferences.
"Our goal has been to bring oliceridine as quickly as possible to patients with the best possible data that gives physicians the information they need to make the right prescribing decisions for those patients," Trevena CEO Maxine Gowen said in the call. "So that is why we have consistently, and unusually, I might say, included morphine in our trials. And I believe we will be rewarded for that."
Trevena stock was down about 30% to $4.97 per share in Tuesday morning trading.