The University of Iowa

UI Pharmaceuticals Collaboration: Alume Biosciences to begin Phase 1/2 clinical trial with investigational drug ALM-488 using supplies produced and tested at UI Pharmaceuticals

UI Pharmaceuticals Collaboration: Alume Biosciences to begin Phase 1/2 clinical trial with investigational drug ALM-488 using supplies produced and tested at UI Pharmaceuticals

University of Iowa Pharmaceuticals (UI Pharmaceuticals), a division of the University of Iowa, College of Pharmacy, is supporting Alume Biosciences Inc. by manufacturing and testing clinical drug supplies of Alume’s investigational drug ALM-488. This drug is being evaluated as a nerve imaging candidate for head and neck injury. ALM-488 is expected to have a broad surgical application due to unique characteristics of binding that are independent of myelin. This allows ALM-488 to highlight multiple types of nerves including motor, sensory, autonomic, and degenerated nerves important during reconstructive procedures. ALM-488 is an intravenously administered peptide-dye conjugate for fluorescence highlighting of nerves during surgery. The primary objective of the Phase 1/2 trial is safety, and secondary objectives include determination of the pharmacokinetics (PK) of ALM-488 as well as efficacy in real-time intraoperative nerve labeling. The study will proceed at three sites including the University California San Diego (UCSD), Stanford Medical Center, and Harvard-Massachusetts Eye & Ear. UI Pharmaceuticals is proud to have been able to support this study by preparing the investigational drug supply. We stand ready to collaborate with all our clients trying to accelerate their novel treatments into human clinical trials.  For more information on Alume Biosciences, Inc. and their drug development projects go to:

https://alumebiosciences.com/news/?0520

https://www.prnewswire.com/news-releases/us-fda-allows-trial-to-proceed-for-alume-biosciences-nerve-imaging-candidate-301051743.html