Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Inclusion Criteria: 1. Male and female patients (18 years and older) 2. Chronic (for at least three months) non-specific pain in the lower back (between the lower ribcage and the gluteal folds) 3. Pain intensity on average at least 4 points on an 11-point NRS (one month before the start of the study) 4. Patients with indicated drug treatment where previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance. 5. Willingness of both men and women to use a reliable method of contraception during study participation and for three months after taking the last dose of the IMP 6. Signed patient information and informed consent form is available 7. Understanding of the German language, ability to give consent and compliance 8. The patient has understood the instructions to avoid changes in lifestyle and dietary habits 9. The patient has understood the principle of the patient diary and gives their consent to keep it as instructed Additional for Phase A a1. Pain intensity averaged at least 4 points on an 11-point NRS (there must be at least 5 pain intensity readings in the morning from the run-in phase) a2. Willingness not to take any analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during participation in study Phase A (except rescue medication) a3. Willingness to continue a current non-drug therapy unchanged as planned during participation in Phase A Additional for Phase B b1. Previous and complete participation in Phase A until and including Visit A6 b2. Patient wishes to participate voluntarily in the long-term study b3. From the investigator's point of view, further participation is considered medically safe b4. Willingness not to take any additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during the last three weeks of study Phase B (except rescue medication). Additional for Phase C c1. Previous and complete participation in Phase B until and including Visit B10 c2. Patient wishes to participate voluntarily in the long-term study c3. From the investigator's point of view, further participation is considered medically safe Additional for Phase D d1. Previous and complete participation in Phase B until and including Visit B10 (patients received Ver-01 for 26 weeks) d2. Patient has experienced a pain score improvement of at least 30% in treatment Phase B (mean value of the study week 43…