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 preliminary, positive, top-line efficacy results from two Phase 2 clinical studies of HTX-011, its lead product candidate for the management of post-operative pain in patients undergoing bunionectomy (Study 208) and inguinal hernia repair (Study 202) and safety data from our ongoing Phase 2 program. HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is the first long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam and is designed to target both post-operative pain and its associated inflammation.
Study 208 – Bunionectomy
Study 208 was a randomized, placebo- and active-controlled, double-blind Phase 2 clinical study in patients undergoing bunionectomy. This study evaluated the efficacy and safety of two formulations of HTX-011 at 200 mg compared to the standard dose of bupivacaine solution and placebo. Bupivacaine solution is the standard-of-care agent for the management of post-operative pain. In addition, HTX-011 was evaluated when administered via Mayo Block (nerve block via closed wound injection) or infiltration (open wound injection).
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). Key secondary endpoints included comparison to bupivacaine solution, the time to first use of opioid rescue medication, total opioid consumption and difference in pain intensity compared to placebo or bupivacaine solution when administered as a Mayo Block or infiltration. The major findings for our Phase 3 formulation of HTX-011 are as follows:
- There was a 66% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by infiltration to placebo (p<0.0001). There was a 64% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by infiltration to bupivacaine solution (p<0.0001).
- There was a 69% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by nerve block to placebo (p<0.0001). There was a 71% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by nerve block to bupivacaine solution (p<0.0001).
- Significant reductions in pain were maintained through 96 hours post-surgery (SPI 0-96) for all groups: HTX-011 by infiltration versus placebo (p=0.005), HTX-011 by infiltration versus bupivacaine solution (p=0.019), HTX-011 by nerve block versus placebo (p=0.004), and HTX-011 by nerve block versus bupivacaine solution (p=0.007).
- Mean time to first opioid rescue medication was 716% longer than for placebo (p<0.0001) and 167% longer than for bupivacaine solution (p<0.036).
- Over the first 24 hours post-surgery, patients receiving HTX-011 consumed 74% less opioids than placebo patients (p<0.0001) and 67% less than bupivacaine solution patients. Over the first 96 hours post-surgery, patients receiving HTX-011 consumed 53% less opioids than placebo patients (p=0.003) and 50% less than bupivacaine solution patients (p=0.008).
Study 202 – Inguinal Hernia Repair
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 two formulations of HTX-011 at two doses (200 mg and 400 mg), compared to placebo.
In addition, two routes of administration into the wound (injection and instillation) were evaluated. 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 SPI 0-24. Key secondary endpoints included the time to first use of opioid rescue medication and total opioid consumption. The major findings for the 400 mg dose of our Phase 3 formulation of HTX-011 as compared to placebo are as follows:
- There was a 29% reduction in pain as measured by SPI 0-24 (p=0.008).
- HTX-011 by instillation (28.4% reduction in SPI 0-24) was equally as effective as HTX-011 by injection (29.2% reduction in SPI 0-24).
- The pain reduction was long-lasting, with a statistically significant, 25% reduction through 48 hours (SPI 0-48; p=0.038).
- Mean time to first opioid rescue medication was 110% longer (13.3 hours versus 27.9 hours).
- Mean total opioid consumption was 36% less through 96 hours post-surgery.
- The number of patients that did not take any opioid rescue medication at all through 96 hours post-surgery was approximately double (21% versus 11%).
HTX-011 has been generally well tolerated in the ongoing Phase 2 program, which has involved more than 250 administrations of HTX-011. The most frequent treatment-related adverse events reported have been nausea and vomiting, which occurred at similar rates in active and control patients.
“With today’s results in hand, we could not be more excited about the potential of HTX-011 to represent a best-in-class therapeutic for post-operative pain,” commented Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics. “HTX-011 is the first extended-release local anesthetic to demonstrate significant benefit over bupivacaine solution, the standard of care for the management of post-operative pain, following bunionectomy, one of the most painful surgeries. As we move toward our broad-based Phase 3 registration program, we remain focused on our goal of delivering a therapeutic tool that can not only greatly reduce pain levels following surgery, but also help address the nationwide burden of opioid abuse and dependence.” (Original Source)
Shares of Heron Therapeutics are up nearly 10% to $18.19 in pre-market trading. 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 $17.49 and its 200-day moving average is $18.97.
On the ratings front, Heron has been the subject of a number of recent research reports. In a report issued on July 27, Jefferies Co. analyst Biren Amin reiterated a Buy rating on HRTX, with a price target of $46, which represents a potential upside of 176.8% from where the stock is currently trading. Separately, on July 20, 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, Biren Amin and Jonathan Aschoff have a total average return of 6.9% and -10.2% respectively. Amin has a success rate of 55.4% and is ranked #470 out of 4085 analysts, while Aschoff has a success rate of 36.5% and is ranked #3982.
Overall, 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $46.50 which is 179.8% above where the stock closed last Friday.
Heron Therapeutics, Inc. is a pharmaceutical company. It designs and commercializes of polymer technologies for pharmaceutical and other applications. The company develops products using its proprietary Biochronomer polymer based drug delivery technology. Its primary focus is on its product APF530, for the prevention of chemotherapy induced nausea and vomiting. 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. Its Biochronomer technology is applicable to a range of therapeutics areas, including prevention of nausea and vomiting, pain management, control of inflammation and treatment of ophthalmic diseases.