Scientific programme

eP65  E-POSTER - 6-9 SEPTEMBER 2017
PAIN TREATMENT (CONSERVATIVE): NOVEL THERAPEUTIC AGENTS

06-Sep-2017 11:30 20:00
 
 
Abstract:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A PREOPERATIVE EGR1 DECOY (AYX1) FOR PAIN AFTER TOTAL KNEE ARTHROPLASTY (TKA)

Aim: AYX1, an EGR1 decoy, designed to reduce acute pain and prevent postoperative chronic pain was tested in subjects undergoing unilateral TKA.

Methods: This phase 2, IRB approved, 2-center study enrolled adults undergoing TKA with spinal anesthesia and standard-of-care (SOC) analgesia. Subjects were randomly assigned (2:1) to intrathecal AYX1 (660mg/6mL or 1100mg/10mL) or matched placebo. Primary efficacy endpoints were mean pain rating (11-pt NRS) while walking 5 meters (0-48 hours) and 15 meters (7-28 days, outpatient period). Secondary endpoints included pain at rest. Safety was assessed in all dosed subjects. Post-hoc analysis included the incidence of pain ≥4 with walking and >0 at rest on day 42.  

Results: 120 subjects were enrolled, 116 dosed and 115 completed the study. AYX1 660mg/6mL + SOC significantly reduced pain with walking and pain at rest during the outpatient period compared to placebo + SOC (p=0.026, p = 0.033 respectively); the 1100mg/10mL dose did not (p=0.423). AYX1 660mg/6mL markedly reduced the incidence of pain ≥4 at day 42 for walking (0% vs. 21%) and pain >0 at rest (26% vs. 74%) compared to placebo. Nearly all subjects reported adverse events but no AYX1-related serious adverse events occurred.

Conclusions: A single preoperative administration of AYX1 660mg/6mL added to SOC significantly reduced both pain with walking and at rest from day 7 through 28, which persisted throughout the study. Fewer subjects with pain ≥4 at day 42 in the 660mg/6mL group compared to placebo supports AYX1’s ability to prevent chronic pain.

NCT 02081703; Funding Adynxx
 
Co-authors
D. Manning 1, K. Hebert 2, S. Harris 3, A. Das 4, J. Mamet 5
1Adynxx Inc, Clinical Development, San Francisco, USA
2Adynxx Inc., Clinical Development, San Francisco, USA
3Adynxx Inc, Regulatory Affairs, San Francisco, USA
4ADstat, Statistics, Guerneville, USA
5Adynxx Inc, Discovery, San Francisco, USA