Istesso

The company’s primary business is the discovery and development of a pipeline of clinical and pre-clinical assets that reprogram cellular metabolism to treat autoimmune and inflammatory conditions. Istesso's therapeutic approach focuses on activating the body's natural adaptive repair mechanisms to rebuild and restore damaged tissue. This method aims to reverse tissue damage caused by conditions like rheumatoid arthritis, idiopathic pulmonary fibrosis (IPF), and multiple sclerosis. The business model centers on advancing its drug candidates through clinical trials to gain regulatory approval and market exclusivity. A key part of their strategy involves securing designations like the FDA's Fast Track and Orphan Drug status to expedite development and review.

Istesso's lead drug candidate is Leramistat (also known as MBS2320), a first-in-class oral agent. This investigational drug has demonstrated a dual mode of action: reducing inflammation and supporting the remodeling of damaged bone and fibrotic tissue. It is in clinical development for treating rheumatoid arthritis and IPF. In a phase 2b trial for rheumatoid arthritis, while not meeting the primary endpoint, Leramistat showed a reduction in bone erosion, supporting its proposed mechanism of action. For IPF, the drug has received both Fast Track and Orphan Drug designations from the U.S. FDA. Istesso's pipeline also includes other assets for conditions associated with autoimmunity, fibrosis, and neuroprotection.