Periodic Reporting for period 2 - Notid (Novel Target for Treatment of Chronic Inflammatory Diseases) Periodo di rendicontazione: 2019-11-01 al 2020-11-30 Sintesi del contesto e degli obiettivi generali del progetto Lipum AB aim to bring to the market a new biological drug (antibody) for treatment of chronic inflammatory diseases. An effective and safe therapeutic alternative has been long expected by the millions of patients that struggle with chronic and debilitating conditions like Rheumatoid Arthritis (RA) and Inflammatory Bowel Disease (IBD). Lipum focus on the orphan disease Juvenile Idiophatic Arthritis (JIA) that affects children. Apart from the patients’ well-being and quality of life, chronic inflammatory diseases also incur high societal costs of healthcare and lost productivity.Our approach is based on the 20+ years of research carried out by the founders of Lipum. We have collected scientific evidence that the protein Bile Salt-Stimulated Lipase (BSSL) plays an important role in inflammation. This discovery is used to develop a new therapeutic antibody that will provide a novel mechanism of action with less adverse effects compared to currently used treatments.The results achieved during the project supported our expectations related to development and selection of a lead candidate drug (SOL-116), and to establish a production method of the antibody to provide material for the nonclinical program ahead of clinical studies. Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti The key results achieved during the project include the selection of final drug candidate SOL-116, advancement in the understanding of its mode of action and the new IP secured by a PCT patent application. A successful CMC development work secured the access of non-GMP material of SOL-116 ahead of toxicological and safety studies. Moreover, Lipum implemented the innovation management routines for its further development and exploitation, validated our strategy for using available fast-track approval procedures and completed the Clinical Development Plan. In parallel, we managed to establish contacts with potential partners and investors. To enable this progress the company’s organization was strengthened by recruiting more staff, contracting consultants and service providers to execute development and communication plans. Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora) With all this progress achieved during the project, Lipum has reached a late pre-clinical stage advancing towards a clinical first-in-human study during 2022. The new treatment is expected to be well-positioned to fill an unmet medical need in the primary indications including RA and JIA. The better understanding of our lead candidates’ unique mode of action will also enable further progress with its application for the treatment of a broader spectrum of chronic inflammatory diseases. 20190320-lipum-11.jpg
