Trial Outcomes & Findings for Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (NCT NCT04238676)

3 participants were recruited into Part A and 40 in Part B. Participants were recruited through community and hospital pain clinics, referrals from other centres and social media campaigns, between Jan 2020 to Dec 2023, at 10 trial sites: 6 in the UK, 2 in Spain, 1 in New Zealand and 1 in Denmark For Part B, the Full Analysis Set consisted of all enrolled subjects who received at least one dose of PP353 or placebo and had a valid post-baseline measurement for at least one efficacy variable.

In Part A, 9 participants were screened, 3 of whom were included in the study. No summary analyses were conducted for efficacy in Part A. In Part B, 136 participants were screened, 40 of whom were randomised and met the criteria to be included in the Full Analysis Set (FAS).

Race and Ethnicity were not collected from any participant.

All causality Treatment Emergent Adverse Events. Any event that was not present prior to the initiation of the treatment, or any event that was already present but increased in intensity or frequency following treatment, was recorded as a treatment-emergent adverse event

Each question will be assessed by the subject on an 11-point scale with 0 = "no pain" and 10 = "the worst possible pain you can imagine." A lower score indicates less pain. The Low Back Pain Numerical Rating score throughout this protocol is defined as the average of the score of the three questions: 1. Low back pain intensity now 2. Worst low back pain intensity in the last 14 days 3. Average low back pain intensity over the last 14 days Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

The ODI is a subject-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. A lower score indicates less disability. Scores are interpreted as follows: 0-20%: minimal disability 21-40%: moderate disability 41-60%: severe disability 61-80% crippled 81-100%: bed-bound Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

Mean Low Back Pain intensity scored on a 0-10 Numerical Rating Scale daily for 7 days prior to a time point visit. Each daily score was recorded on an 11-point NRS scale where 0 = "no pain" and "10 = the worst pain you can imagine". A lower score indicates less pain. Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.