IMSB301 / ImmuneSensor Therap - LARVOL DELTA

ImmuneSensor Therapeutics Receives Orphan Drug and Rare Pediatric Disease Designations from the U.S. FDA for cGAS Inhibitor Drug Candidate, IMSB301, for the Treatment of Aicardi Goutières Syndrome (AGS) (GlobeNewswire) - "ImmuneSensor Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for the company’s lead anti-inflammatory and autoimmunity drug candidate, IMSB301 for the treatment of cGAS-driven Type I interferonopathy, Aicardi Goutières Syndrome (AGS)....'We currently have an ongoing Phase 1 trial of IMSB301 in healthy volunteers that will provide important early safety and target engagement data and inform rapid advancement to Phase 1b/2 clinical studies in patients with AGS and other severe inflammatory diseases, including lupus.'"

FDA event • Orphan drug • Aicardi Goutieres Syndrome • Interferonopathies

ImmuneSensor Therapeutics Initiates Dosing in Phase 1 Clinical Trial of Lead cGAS Inhibitor Drug Candidate, IMSB301 (GlobeNewswire) - "ImmuneSensor Therapeutics...announced today that the first dose level cohort of healthy volunteers has been dosed in a Phase 1 randomized, double-blinded, placebo-controlled clinical trial of its lead oral cGAS inhibitor drug candidate, IMSB301, which is being developed for the treatment of a range of inflammatory and autoimmune diseases....'We anticipate having safety, pharmacokinetic, and target engagement data from our Phase 1 trial in healthy volunteers by the end of 2024, positioning us to efficiently transition into Phase 1b/2 clinical studies for patients with severe inflammatory conditions, specifically Type 1 interferonopathies.'"

P1 data • Trial status • Immunology • Inflammation • Interferonopathies

ImmuneSensor Therapeutics Granted New U.S. Patent for its Oral cGAS Inhibitors (GlobeNewswire) - "ImmuneSensor Therapeutics...announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. patent No. 12,091,387 containing claims covering compositions of matter and methods of use of ImmuneSensor’s proprietary potentially best-in-class cGAS inhibitors for a variety of inflammatory conditions, including allergic, autoimmune, cardiovascular, ocular inflammation, and neurodegenerative diseases....ImmuneSensor plans to initiate Phase 1b/2 clinical studies in selected patients with severe inflammatory diseases known as Type 1 interferonopathies, including Aicardi Goutières syndrome (AGS)...and in defined patient populations with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE)."

Patent • Aicardi Goutieres Syndrome • CNS Disorders • Immunology • Inflammation • Interferonopathies • Systemic Lupus Erythematosus

ImmuneSensor Therapeutics Receives Clearance from Australian Regulators to Initiate a First-in-Human Phase 1 Clinical Trial of cGAS inhibitor Drug Candidate, IMSB301 (GlobeNewswire) - "Company expects to initiate its Phase 1 clinical trial in healthy volunteers in 3Q2024 and move rapidly into Phase 1b/2 clinical studies in Type I interferonopathies....ImmuneSensor Therapeutics....announced that it has received Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to initiate a Phase 1 randomized placebo-controlled, double-blinded clinical trial of its lead anti-inflammatory and autoimmunity drug candidate, IMSB301, in healthy volunteers. IMSB301 is a novel, orally available small molecule cGAS inhibitor that is being developed for the treatment of inflammatory and autoimmune diseases."

New P1 trial • Aicardi Goutieres Syndrome • Immunology • Inflammation • Interferonopathies