Company: INCR
Filing Date: 2025-05-01
Form Type: 20-F
Source: 0001641172-25-007971
Chunk: 81

Company: Intercure Ltd.
Filing Date: 2025-05-01
Form: 20-F
Item: Item 4
Chunk 81
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 now considering to end the trial process.
 
We received the approval of the IMCA to conduct nine advanced clinical trials based on additional medical cannabis products in the IMC-GMP standard in strategic collaboration with leading medical centers in Israel. In some of the clinical trials we will serve as the initiator of the clinical trials conducted by the research partners, while in others we will only provide our products for use in the clinical trials and have access to the results. The program includes clinical trials of the Company’s products on a variety of medical indications (epilepsy, fibromyalgia, neuropathic pain, side effects of chemotherapy in cancer patients, Parkinson’s, rheumatoid arthritis, radicular pain, post-trauma) and radiculopathy (PTSD). In addition, we submitted an application for approval of a clinical study to examine the effect of cannabis use on the dose and / or frequency of opioid use in collaboration with Sheba Hospital.
 
Our clinical studies program experienced significant setbacks in 2020-2021 as a result of COVID-19, and at this point, we remain uncertain as to when the studies will be initiated. Additionally, due to significant delays in our clinical program timeline and changes in excepted regulations in Israel, EU and the U.S., we are currently evaluating our clinical program. As of the date of this Annual Report, the majority of the clinical trial costs are being borne by our partners.
 

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The table below provides additional details regarding our and our partners’ currently planned clinical trials:
 

                                                                                                                                                                 Our                                                                                                                                                                  
                                                                                                                                                       Planned Clinical Trials                                                                                                                                                        
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         Phase        Indication                                     Number        Primary                                                                                          Secondary                                                                                                                                         
of Development                                                  of Patients        Endpoint(s)                                                                                      Endpoint(s)                                                                                                                                       
             2        Adult                                              52        ●Change                                                                                          ●                                                                                                                                                 
                      Epilepsy                                                     in median monthly seizure frequency over study period compared to 2-month baseline period        Changes in seizure severity                                                                                                                       
                                                                                   ●Treatment-emergent                                                                              ●                                                                                                                                                 
                                                                                   adverse events and serious adverse events (“SAEs”) during treatment                              Change in speed of post-ictal recovery                                                                                                            
                                                                                                                                                                                    ●                                                                                                                                                 
                                                                                                                                                                                    Changes in seizure characteristics (focal/generalized)                                                                                            
                                                                                                                                                                                    ●                                                                                                                                                 
                                                                                                                                                                                    Changes in quality of life based on QoL31                                                                                                         
                                                                                                                                                                                    ●                                                                                                                                                 
                                                                                                                                                                                    Changes in sleep quality based on the Pittsburgh sleep questionnaire                                                                              
             2        CINV                                               72        ●SAEs