May 26, 2021

Successfully completes phase 1 clinical trial

Avilex Pharma successfully completes its phase 1 clinical trial of AVLX-144 – A potentially game-changing treatment for acute neurological conditions

Avilex Pharma, a clinical stage biotechnology company developing innovative treatments for acute neurological conditions such as acute ischemic stroke (AIS) and subarachnoid haemorrhage (SAH), is excited to announce the successful completion of the company’s first-in-human Phase 1 clinical trial of its lead compound AVLX-144.

During the course of the Phase I study, AVLX-144 was well-tolerated and demonstrated no noteworthy safety issues related to treatment  The result provides a solid foundation for Avilex’s transition into later phase clinical trials to further study the compound’s efficacy.

“We are extremely pleased with the successful outcome of our first-in-human study, firstly being able to conduct and finalize the Phase 1 study under the challenging Covid19 conditions, and secondly as the results obtained are as good as we could have hoped for.” says Mikael Thomsen, Chief Development Officer at Avilex Pharma

Kristian Strømgaard, Ph.D., Chief Executive Officer at Avilex Pharma adds “This is a major milestone for Avilex. As we think back to all the hard work that went into this achievement and celebrate it, we are also excited about what this means for patients moving forward as we progress through the next phases of clinical development and continue on a path to providing a safe and efficacious treatment option for patients,”

The Phase I single ascending dose study was conducted in collaboration with Clinical Research Services Turku (CRST) in Finland. The study examined the safety, tolerability, and pharmacokinetics of AVLX-144 and identified the recommended Phase 2 dose. Avilex Pharma plans to initiate a Phase 2 trial with the primary 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, a clinically validated mechanism (ref), using proprietary dimeric ligands that target two protein modules of PSD-95 simultaneously. This strategy has 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.

The AVLX-144 program was supported by funding from the Danish Innovation Fund Grand Solutions Program and the Wellcome Trust Translational Award, as well as investments from Novo Holdings and Vækstfonden.

For Additional information contact:Kristian Strømgaard, Professor, PhDCEO & CSO, Avilex PharmaPhone: (+45) 5123 6114E-mail: kristian.stromgaard@avilexpharma.com