Callan JMB Inc. to Oversee Manufacturing and Quality Control of Attune Biotech’s IND Clinical Trials for lodonal™ in the Treatment of Long COVID

Core Insights - Callan JMB Inc. has partnered with Attune Biotech to provide independent oversight for clinical trials of JKB-122 (lodonal), aimed at treating Long COVID, a condition affecting approximately 20 million Americans [1][3][4] Group 1: Company Overview - Callan JMB Inc. is an integrative logistics company that supports the healthcare industry through fulfillment, storage, monitoring, and cold chain logistics services [1][5] - The company has extensive expertise in supply chain logistics, regulatory compliance, and emergency preparedness, positioning it as a leader in the industry [5] Group 2: Partnership Details - The strategic agreement with Attune includes Callan JMB serving as an independent third-party overseer for manufacturing, quality assurance, and deployment operations related to the IND application for JKB-122 [2][4] - Callan JMB will provide services such as CMO qualification, batch record review, supply chain verification, and distribution pathway validation [2] Group 3: Clinical Trial Information - Attune has received FDA notification for IND application number 181314 for JKB-122, which is currently in development for Long COVID [3] - The clinical trial will be a randomized, double-blind, placebo-controlled, multi-center Phase 2b/3 study evaluating the safety and efficacy of JKB-122 in adults with Long COVID [4] Group 4: Product Development - JKB-122 is a first-in-class TLR4 antagonist designed for immune restoration and is being developed for multiple conditions, including Long COVID and autoimmune diseases [4][6] - The product is protected by intellectual property extending through 2041, indicating a long-term development strategy [4][6]