Trevena Inc (NASDAQ:TRVN) released two Phase III trials that demonstrated efficacy and achieved endpoints for its prime product candidate, Oliceridine. However, the safety and side effect profile was uninspiring. Without interesting safety report, Oliceridine faces dismal commercial prospects.
The buzz
Biotech pain-focused Trevena released data from Phase 3 trials Apollo and Apollo 1 that were mainly as expected. The lead drug, Oliceridine, recorded strong efficacy report, whereas the safety profile and side effect profile were underwhelming.
Analysts continue to consider shares have further weakness in spite of what they consider as a likely approval. With dismal side effect report, they to note considerable problems to commercial adoption. Hence, on a risk-adjusted basis, analysts target on stock is around $2 to $3. The most apparent positive report from the Phase III trials was the efficacy profile of drug candidate Oliceridine.
As in Phase II, Oliceridine showed superior time to significant relief and higher pain relief scores. albeit it was recorded at higher doses. A rapid onset surely has some clinical advantage, but as noted before, that advantage is limited. It comes with increased doses, which can have an impact on the side effect profile.
Moreover, Oliceridine showed efficacy comparable to morphine. Oliceridine showed analgesic efficacy versus placebo, which was the trial’s major endpoint. Because the analgesic effect can mainly be accredited to placebo, any conclusive analgesic effect is of prime importance. The promising outcomes of the Phase III trials are consistent with Phase II, however as evident from the 40% drop in the stock price, the negatives overshadowed the positives.
Oliceridine’s main value proposition has been its possibly lower side effect profile. Trevena reported that in Phase II, Oliceridine showed a superior side effect profile. With a bigger sample size, Oliceridine showed comparable side effect summaries to morphine. At increased doses that had comparable efficacy to morphine, the lead drug candidate showed similar levels of nausea, headache, somnolence, vomiting and dizziness.
