SAN FRANCISCO, August 2, 2022 (Newswire.com) - Elixiron Immunotherapeutics, a clinical stage biotech company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its colony stimulating factor‑1 receptor (CSF‑1R) inhibitor, EI‑1071 for the treatment of idiopathic pulmonary fibrosis (IPF).
"Idiopathic pulmonary fibrosis has a devastating impact on patients' lives and more effective therapies are urgently needed, and the Orphan Drug Designation validates the potential of EI‑1071 to offer a new therapeutic option for patients living with this disease," said Hung-Kai Kevin Chen, Chief Executive Officer of Elixiron. "Building on promising data from preclinical and phase I studies, we are actively evaluating options to accelerate the development of EI‑1071 to address unmet medical needs."
Orphan Drug Designation serves to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the U.S., providing for various incentives including tax credits for eligible clinical trials, waiver of application fees, and market exclusivity for seven years upon FDA approval.
About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis is a chronic interstitial lung disease characterized by tissue fibrosis and progressive decline in lung function. Currently, there is no cure for IPF and only two approved drugs slow but do not halt disease progression. On average, patients with IPF continue to live for only three to five more years once diagnosed with IPF.
EI‑1071 is an orally-administered, small molecule inhibitor of colony stimulating factor‑1 receptor (CSF‑1R) that has completed Phase I development. CSF‑1 signaling plays an important role in the regulation of pulmonary macrophages which drive inflammatory damage and tissue fibrosis in IPF. CSF‑1R blockade with EI‑1071 shows promising therapeutic effects, ameliorating lung fibrosis and improving respiratory functions in preclinical models of IPF. Besides IPF, EI‑1071 can inhibit brain microglia-mediated neuroinflammation in preclinical models of Alzheimer's disease, and is being developed for treatment of Alzheimer's disease with funding support in part from the Alzheimer's Association Part the Cloud program.
About Elixiron Immunotherapeutics
Elixiron Immunotherapeutics is focused on the development of innovative immunotherapies to address unmet needs in rare and immunological diseases. Besides EI‑1071, Elixiron has an interferon-gamma-neutralizing antibody currently in a phase 1 trial that is being developed for the treatment of hemophagocytic lymphohistiocytosis and vitiligo. For more information, visit elixiron.com and follow the company on Linkedin.
Source: Elixiron Immunotherapeutics