A game-changing treatment for acute ischemic stroke
A game-changing treatment for acute ischemic stroke
Avilex Pharma, a biotechnology company developing innovative treatments for acute conditions such as acute ischemic stroke (AIS) and subarachnoid haemorrhage (SAH), today announced that it has dosed the first human volunteer in a Phase 1 clinical study with lead compound AVLX-144.
Acute ischemic stroke is a leading cause of death and disability worldwide with few treatment options available, while subarachnoid haemorrhage is a particular form of stroke and an orphan indication. Avilex Pharma is currently developing drugs for the treatment of ischemic stroke based on a novel concept of inhibiting the neuronal scaffolding protein, PSD-95. The neuroprotective effects of targeting PSD-95 were recently validated as a promising drug target for ischemic stroke (Hill et al. Lancet 2020). “When we combine the positive results from our extensive preclinical characterization of AVLX-144 with the mechanistic proof of concept recently demonstrated in human stroke studies, we are convinced that we have a unique opportunity to make a transformative difference for patients,” says Kristian Strømgaard, Ph.D., Chief Executive Officer at Avilex Pharma. “We are extremely proud to reach this key milestone, having now successfully designed, manufactured, and dosed a completely novel, best-in-class compound. We look forward to progressing the Phase 1 clinical study and gathering important human data on AVLX-144 in the months ahead.” The Phase I single ascending dose study is being conducted in collaboration with Clinical Research Services Turku (CRST) in Finland. The study is designed to examine the safety, tolerability, and pharmacokinetics of AVLX-144 and to determine a recommended Phase 2 dose. Following completion of the study, Avilex Pharma expects to initiate a Phase 2 trial with the primary of objective of evaluating the clinical efficacy of AVLX-144.
About Avilex Pharma
Avilex Pharma is a clinical stage biotech company developing a novel class of neuroprotectants based on inhibiting PSD-95 using dimeric ligands that target two protein modules of PSD-95 simultaneously. This strategy led to the identification of lead compound AVLX-144, whose specific design provides key advantages, such as exceptionally high affinity to PSD-95, excellent stability, and enhanced neuroprotective properties in vivo. Avilex Pharma is also evaluating AVLX-147, a second generation high affinity, tPAresistant PSD-95 inhibitor being developed for the treatment of acute ischemic stroke. Recent non-clinical safety as well as promising in vivo pharmacology data have strongly supported further development of AVLX-147, and the compound is currently undergoing late stage preclinical (safety) evaluation.
The current AVLX-144 program has been initiated with funding from the Danish Innovation Fund Grand Solutions Program and the Wellcome Trust Translational Award, as well as investment from Novo Holdings and Vækstfonden.
