Recro Pharma ($REPH) is planning to halt a midstage study of its lead candidate, a nonopioid pain drug, after an interim analysis revealed it had little hope of meeting its goals, sending the company's shares tumbling more than 45%.
The drug, Dex-IN, is in the midst of a placebo-controlled Phase IIb trial to test whether it can treat postoperative pain in patients who have just had bunions removed. Peeking at results from the first half of patients enrolled, however, Recro determined its top prospect wasn't on track to meet its primary endpoint, a reduction in self-reported pain intensity over 48 hours. And a larger sample size is unlikely to help Dex-IN close the gap, the company said, making it pointless to follow through on the study.
The news nearly halved the small biotech's stock value in premarket trading on Friday, sending it as low as $2.80. That's roughly 65% below the $8 a share the company pulled off in its $30 million March IPO.
But Recro's not giving up on the drug. Combing through the data, the company noted that subjects with more moderate pain intensity scores were more effectively managed compared to placebo, needing about 50% less opiate treatment. And, according to Recro, patients a day removed from surgery tend to report more moderate scores than those who've just undergone it, pointing the way to a better study population.
"Based on what we know about the trajectory of pain, together with these observations, which confirm our earlier trial results and demonstrate efficacy for the first time in acute post-op pain, we believe that a study of 50-mcg Dex-IN in a post-op Day 1 setting is the best path forward," CEO Gerri Henwood said in a statement.
The new plan is to kick off a revised Phase II study next quarter, the company said, chasing the same results but this time enrolling day-after bunionectomy patients. Recro intends to recruit between 150 and 200 subjects, expecting to report out top-line results by the middle of next year.
Back in March, Recro said its $30 million haul would pay Dex-IN's way through clinical development, but it's unclear whether the biotech has enough in the bank for a Phase II do-over. At the end of the second quarter, the company reported having cash and equivalents of $27.8 million, money it said would keep the doors open through 2015.
- read the statement (PDF)