More than doubling its stock since the first of the year, San Diego’s Heron Therapeutics reported yet another slam dunk Thursday morning with news that its pain drug delivered in two more indications. That’s after the company reported stellar Phase III data just three months ago, and a FDA OK on a different drug before that.
Heron’s investors are pleased with the news, with the company’s stock $HRTX jumping 30% in pre-market trading.
The company’s pain drug is a long-acting local anesthetic made up of bupivacaine and meloxicam, which Heron calls HTX-011. The drug was tested in two Phase IIb studies against the pain associated with total knee arthroplasty and breast augmentation. Both studies enrolled between 222 and 243 patients, and were randomized, placebo-controlled, and double-blind. The patients were split into four cohorts, with one group receiving HTX-011 as a monotherapy, while the others either got an HTX-011 combo with ropivacaine, a placebo, or the anesthetic bupivacaine (the current standard of care).
Heron met the primary endpoints in both studies, showing that HTX-011 and the combo worked significantly better at reducing pain than bupivacaine and the placebo. In the knee study, The HTX-011 combo and HTX-011 alone resulted in reductions of 23% and 19% respectively in pain intensity measured at rest through 48 hours when compared to placebo (p<0.0001 and p=0.0002, respectively). That’s double the pain reduction than that of bupivacaine, which only reduced pain intensity by 11%.
The breast augmentation study results were similarly strong, with Heron’s drug achieving nearly triple the pain reduction than that of bupivacaine. HTX-011 resulted in reductions of 22% in pain intensity measured at rest through 24 hours, while bupivacaine resulted in a reduction of 8%.
This is the second wave of good news for HTX-011, which wowed investors in March for its efficacy against post-surgery pain after bunionectomy (bunion removal) and hernia repair.
“With postoperative opioids serving as a gateway to addiction, there is a large unmet need for non-opioid pain alternatives,” said Barry Quart, Heron’s CEO, in a statement. “With the results reported today, we have seen positive results across 7 controlled clinical studies and 5 diverse surgical models, including hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation.”
In a note to investors earlier this year, analysts at Jefferies suggested the pivotal readout for HTX-011 would be a “significant catalyst” for Heron. The company plans to file an NDA for the program later this year.
The good news for the company follows a regulatory win late last year, when Heron scored FDA approval of Cinvanti to prevent nausea and vomiting for patients on chemo. It was the second anti-nausea drug in Heron’s product portfolio, with Sustol approved last August for the same indication.
Heron’s stock has climbed 88% since that Cinvanti win back in November, and could climb as much as 139% if Heron’s stock opens Thursday at its pre-market price.
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