A game-changing treatment for acute ischemic stroke

October 12, 2020

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.

For additional information contact: Kristian Strømgaard, Professor, PhD CEO & CSO, Avilex Pharma

Phone: (+45) 5123 6114 E-mail: kristian.stromgaard@avilexpharma.com