Heron Therapeutics Inc (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, announced that results from the initial portions of Heron’s Phase 2 study of HTX-011 in patients undergoing inguinal hernia repair (Study 202) will be presented today in two posters at PAINWeek®, the national conference on pain for frontline practitioners, in Las Vegas, NV. The posters were co-authored by Harold S. Minkowitz, MD, Diplomat American Board of Anesthesiology, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center and Peter J. Winkle, MD, FACP, CPI, FACG, Anaheim Regional Medical Center, Anaheim Clinical Research.
Study 202 was a randomized, placebo-controlled, double-blind Phase 2 clinical study in patients undergoing inguinal hernia repair. The study evaluated the efficacy and safety of three formulations of HTX-011 and two routes of administration into the wound (injection and instillation). Instillation into the incision site is an easier and potentially safer route of administration as it avoids multiple injections around the wound (as many as 10 or more in large operations) that carry the risk of venous puncture.
The primary endpoint was the difference as compared to placebo in pain intensity as measured by the Summed Pain Intensity (SPI) score in the first 24 hours post-surgery (SPI 0-24). Important secondary endpoints included SPI for the first 48 hours post-surgery, total opioid consumption, and the percent of patients opioid-free through 96 hours post-surgery. Today’s presentations describe Part B of the study (202B), which compared our planned Phase 3 formulation of HTX-011 (HTX-011B) at 200 mg (n=30) and 400 mg (n=30) to saline placebo (n=31). The major findings for the 400 mg dose of HTX-011B as compared to placebo are as follows:
- There was a 29.5% reduction in pain as measured by SPI 0-24 (p=0.0035).
- Instillation (29.9% reduction in SPI 0-24) was equally as effective as injection (29.1% reduction in SPI 0-24).
- The pain reduction was long-lasting, with a statistically significant, 25.2% reduction through 48 hours (SPI 0-48; p=0.0250).
- Mean total opioid consumption decreased by 22.4% through 96 hours post-surgery.
- The number of patients who were opioid-free through 96 hours post-surgery was substantially higher (24.1% versus 6.5%).
HTX-011 has been generally well tolerated in the ongoing Phase 2 program, which has involved more than 250 administrations of HTX-011. In Study 202B, the frequency of treatment-related adverse events reported was 38.7% in the HTX-011B 200 mg group, 33.3% in the HTX-011B 400 mg group, and 51.6% in the placebo group. The most frequent treatment-related adverse events reported were nausea, constipation and headache.
“I have been working in acute pain research for 25 years and I have worked with many new products. I am extremely impressed with the efficacy of HTX-011,” commented Harold S. Minkowitz, MD, Diplomat American Board of Anesthesiology,Department of Anesthesiology, Memorial Hermann Memorial City Medical Center. “Additionally, the unique ability to instill HTX-011 with equal efficacy to a standard infiltration technique provides a fast, easy and safe route of administration.”
“The results presented today give us confidence as we prepare for our broad-based Phase 3 registration program,” commented Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics. “We remain focused on our goal of delivering a therapeutic tool that can not only greatly reduce pain levels following surgery, but also reduce the burden of opioids.”
PAINWeek® 2016 Posters
Heron’s posters from PAINWeek® 2016 are available on Heron’s website (www.herontx.com) under Scientific Posters and Presentations under the following titles:
- Local Administration of HTX-011, a Long-Acting Biochronomer®-Based Bupivacaine/Meloxicam Combination, in Hernia Repair: Preliminary Results of an Interim Analysis
- Local Administration of HTX-011, a Long-Acting Biochronomer®-Based Bupivacaine/Meloxicam Combination, in Hernia Repair Provides Similar Initial Results Whether Injected or Instilled. (Original Source)
Shares of Heron closed yesterday at $18.45, up $0.21 or 1.15%. HRTX has a 1-year high of $42.25 and a 1-year low of $15.22. The stock’s 50-day moving average is $18.90 and its 200-day moving average is $18.84.
On the ratings front, Heron has been the subject of a number of recent research reports. In a report issued on September 6, Lake Street Capital analyst Bruce Jackson assigned a Buy rating on HRTX, with a price target of $45, which implies an upside of 143.9% from current levels. Separately, on August 11, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $55.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Bruce Jackson and Jonathan Aschoff have a total average return of -1.0% and -9.6% respectively. Jackson has a success rate of 37.5% and is ranked #2933 out of 4147 analysts, while Aschoff has a success rate of 37.6% and is ranked #4019.
The street is mostly Bullish on HRTX stock. Out of 7 analysts who cover the stock, 7 suggest a Buy rating . The 12-month average price target assigned to the stock is $46.50, which represents a potential upside of 152.0% from where the stock is currently trading.
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.