Heron Therapeutics, Inc. (NASDAQ:HRTX) announced positive topline results from its Phase 2 study of the investigational agent HTX-011 in subjects undergoing abdominoplasty (Study 203). HTX-011 demonstrated statistically significant reductions in both pain intensity and the use of opioid rescue medications through 96 hours following surgery.
Study 203 is a randomized, placebo-controlled, dose-finding, Phase 2 clinical study evaluating the efficacy and safety of locally administered HTX-011 for post-operative anesthesia following abdominoplasty surgery. The Summed Pain Intensity (SPI) score through 96 hours post-surgery (SPI 0-96) was significantly reduced with HTX-011 and produced a statistically significant 36.6 percent reduction in pain through 96 hours following surgery, as measured by SPI 0-96 (p=0.0104). Pain was consistently reduced through 96 hours with statistically significant reductions observed between 24 to 48 hours (p=0.007), 48 to 72 hours (p=0.038), and 72 to 96 hours (p=0.016) after a single administration of HTX-011.
Additionally, HTX-011 produced significant reductions (p=0.011) in the use of opioid rescue medication through 96 hours following abdominoplasty, as compared to placebo. To date, HTX-011 continues to be generally well-tolerated in Phase 2.
“The most painful period following surgery is the first three to four days. Currently available local anesthetics do not have the duration of action to provide analgesia for these critical first few days. Poorly managed post-operative pain can result in impaired patient function, increased cost of care and potentially lead to chronic pain and long-term opioid use,” commented Harold S. Minkowitz, MD, Diplomat American Board of Anesthesiology, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center. “However, the efficacy of HTX-011 in even one of the largest surgical incisions, like abdominoplasty, demonstrates its potential to provide durable post-operative pain relief in a wide variety of surgical procedures, reducing or eliminating the need for opioids.”
“Today’s abdominoplasty results, combined with previously reported data from our Phase 2 programs in bunionectomy and hernia repair, demonstrate the potential for HTX-011 to provide broad utility and efficacy across multiple surgery types, from the smallest to one of the largest surgical incisions,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. “The robust, long-lasting results seen across multiple surgical settings indicate that HTX-011 has the necessary attributes to be a best-in-class therapeutic for post-operative pain, extending relief following surgery and, in turn, reducing the need for, and risks associated with, opioid intervention.”
HTX-011 is the first long-acting anesthetic that is designed to address both post-operative pain and accompanying inflammation by combining the local anesthetic bupivacaine and the anti-inflammatory meloxicam in a single administration. Targeting both pain and inflammation has allowed HTX-011 to demonstrate an advantage over current standard of care in multiple surgical models in Phase 2 studies. (Original Source)
Shares of Heron Therapeutics are currently rising 1.45% to $14.00, or up $0.20 in after-market trading Wednesday. HRTX has a 1-year high of $28.10 and a 1-year low of $12.30. The stock’s 50-day moving average is $15.16 and its 200-day moving average is $17.16.
On the ratings front, Heron Therapeutics has been the subject of a number of recent research reports. In a report issued on December 9, Cowen analyst Boris Peaker reiterated a Buy rating on HRTX, with a price target of $40, which implies an upside of 197% from current levels. Separately, on November 15, Leerink Swann’s Jason Gerberry reiterated a Buy rating on the stock and has a price target of $34.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Jason Gerberry have a yearly average return of 3.3% and a loss of -9.4% respectively. Peaker has a success rate of 37% and is ranked #1156 out of 4351 analysts, while Gerberry has a success rate of 26% and is ranked #4212.
Sentiment on the street is mostly bullish on HRTX stock. Out of 5 analysts who cover the stock, 5 suggest a Buy rating . The 12-month average price target assigned to the stock is $40.50, which implies an upside of 201% from current levels.
Heron Therapeutics, Inc. is a biotechnology company develops pharmaceutical products for patients suffering from cancer or pain. The company develops products by using its proprietary Biochronomer polymer based drug delivery technology. Its primary products are SUSTOL, HTX-019 and HTX-011. The company has additional clinical and preclinical-stage programs in the area of pain management, all of which utilize its bioerodible, injectable and implantable delivery systems.