POS0017 IMC-1, A FIXED DOSE COMBINATION OF FAMCICLOVIR AND CELECOXIB, IMPROVES COMMON SYMPTOMS ASSOCIATED WITH FIBROMYALGIA IN ADDITION TO PAIN: POST HOC ANALYSIS OF A PHASE 2A TRIAL

Background: Fibromyalgia is a chronic disease characterized by widespread pain and severe fatigue that may be triggered reactivation of latent herpes simplex virus type 1 (HSV-1). In Phase 2a proof concept trial, IMC-1 (a fixed dose combination famciclovir celecoxib) demonstrated greater tolerability statistically significant reduction in compared with placebo, as measured change from baseline to week 16 24-hour recall intensity on an 11-point Numerical Rating Scale (NRS) 7-day the item Revised Impact Questionnaire (FIQ-R). Objectives: this post hoc analysis, we evaluated effects placebo other fibromyalgia symptoms, including lack energy, stiffness, problems sleep, memory, depression, anxiety. Methods: double-blind, multi-center, placebo-controlled male or female patients 18–70 years age who met diagnostic criteria for had at average score between 4 9 NRS were randomized 1:1 weeks treatment placebo. Mean changes FIQ-R symptom scores analyzed using Mixed-Effect Model Repeated Measure (MMRM) model main effect, investigative site covariates. Results: A total 143 enrolled (n=69) (n=74). Baseline demographic clinical characteristics comparable groups; majority Caucasian (95.8%) (93.7%) mean ~49 years. Compared resulted improvements stiffness (least squares -0.96 vs. -1.92, P=0.03), sleep quality (-0.76 -1.76, P=0.039), depression (-0.44 -1.33, P=0.016), anxiety (-0.30 -1.69, P<0.001), but not energy level (-0.67 -1.29, P=0.115) memory (-0.71 -1.24, P=0.165). Conclusion: addition alleviation pain, appears effective improving many symptoms often associated fibromyalgia. Further trials are warranted. References: [1]Pridgen WL, Duffy C, Gendreau JF, RM. + celecoxib safe efficacious J Pain Res . 2017;10:451-460. Disclosure Interests: William Pridgen Consultant of: Virios Therapeutics, Carol Grant/research support from: The University Alabama, Department Biological Sciences has received financial research Innovative Med Concepts (now Therapeutics) form two Sponsored Research Agreements., Judy F. Tonix, Dare Bioscience, R. Michael Teva, Swing Employee Therapeutics.