News
Neonatal Diagnostics Company InfanDx AG Completes Two-Year Patient Follow-Up in BANON Study
— Clinical data curation and evaluation ongoing
— Follow-up rate of 77% fully meets expectations (70-80%)
— Final HIE biomarker panel validation data expected by end of Q3-2022
InfanDx AG, a privately held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, announced at an investigator meeting during the recent 48th Annual Meeting of the German Society for Neonatology and Pediatric Intensive Medicine that the clinical 2-year follow-up of patients originally enrolled in the BANON study was formally completed. The study is designed to validate novel diagnostic biomarkers of Hypoxic-Ischemic Encephalopathy (HIE).
selectION, Inc. Advances Lead Program for Treatment of T Cell Mediated Autoimmune Diseases to Clinical Development
– Novel ion channel blocker designed to combine high efficacy and durable response while maintaining full immune system functionality
San Diego, CA, USA, and Munich, Germany – May 9, 2022 – selectION, Inc., a biopharmaceutical company developing novel peptide therapies for the treatment of T cell mediated autoimmune diseases and rare lymphomas, today announced that Germany´s regulatory agency has authorized the Company’s clinical trial application for a Phase 1b trial evaluating the safety and efficacy of selectION´s clinical candidate, si-544, in patients diagnosed with mild to severe atopic dermatitis.
Omnix Medical Starts Phase I Clinical Trial of Novel Anti-Infective; First Healthy Volunteers Dosed
– New mechanism of action (MoA) addressing global increase of antimicrobial resistance (AMR) burden and shortage of potent anti-infectives
Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced the initiation of a Dutch Phase I clinical trial with its lead compound OMN6. Since March 28, 2022, six healthy volunteers have been administered the novel antimicrobial, which is based on a naturally occuring mechanism of action (MoA) leading to a targeted, effective destruction of the cell membrane of pathogens. The trial is being conducted in Groningen, The Netherlands. OMN6 is being evaluated in a randomized, double-blind, placebo-controlled, single ascending dose trial assessing safety, tolerability, and pharmacokinetics of single and repeat IV infusion of the compound in healthy subjects. Results are expected by Q4, 2022.
Neonatal Diagnostics Company InfanDx AG Launches US Operations
— Incorporated US subsidiary & hired US VP Operations
— Preparing pre-submission meeting with US-FDA
— Received Notice of Allowance for key patent by USPTO
InfanDx AG, a privately-held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, today announced that it has set up US operations to gain access to the US market for its HypoxE® Test. The test is designed for the early detection of Hypoxic-Ischemic Encephalopathy (HIE) and is currently in clinical development.