180 Life Sciences Corporate Media Kit

15 180 LIFE SCIENCES clinical trial 2b/3 - Nanchahal J et al, 2017 Wellcome Open Research, 2:37 Phase 2b/3 Trial Fully Enrolled – Local Adalimumab in Early DD • Randomized blinded trial in patients with early DD injected with optimal dose adalimumab (1) • Every 3 months for 1 year (4 injections), following for a total of 18 months • Outcome measures include nodule hardness, size and disease progression • Randomized 181 patients across 3 sites in UK and the Netherlands • FULLY ENROLLED, FULLY PAID FOR • All UK patients have received final injection • Results expected Q4 2021 • Trial sites: Oxford, Edinburgh, Groningen (1) Approval only from MHRA/CCMO and relevant accredited ethics committees. Primary Objective Secondary Objectives Tertiary Objectives To determine if injection with adalimumab is superior to placebo injection of normal saline in controlling disease progression. Hardness of selected nodule. 1. To compare the development of Dupuytren’s nodules and associated cord, flexion deformities of the fingers and impairment of hand function for participants on each treatment. 1.1. Ultrasound imaging of nodule size. 1.2. Range of motion of the affected digit. 1.3. Grip strength. 1.4. Participant Reported Outcomes: Michigan Hand Outcomes Questionnaire (MHQ) Participant identified activity most restricted by DD scored on a scale of 1-10. 1.5. Clinical assessment of the hand. 2.1. Adverse event assessment comparing active and placebo groups using visual inspection of injection site and laboratory reports. 2.2. Progression to surgery of the digit being assessed. 3. Analysis of health care resource utilisation data and EQ-5D-5L data to estimate cost and utilities from participants on each treatment. 4. Analysis of blood sample. 2. Monitor for adverse events. 3. To assess if early DD injection therapy represents good value for money compared to current clinical care. 4. Monitor circulating levels of adalimumab and antibodies to adalimumab in the blood. Objectives Outcome measures 180 Life Sciences Corp. www.180lifesciences.com Q4 2020