TikoMed’s Policy on Early Access to ILB®

TikoMed is committed to the clinical development of ILB®, aiming for clinical trials and regulatory approval with the goal of bringing ILB® to the widest possible population that may benefit from it. Clinical trials remain the backbone of the development of ILB® and are essential to demonstrate sufficient safety and efficacy to gain regulatory approval for ILB®.

TikoMed is closely involved with the ALS patient community and understands the community’s desire to access treatments for ALS as quickly as possible. Early access is a regulatory pathway which allows patients diagnosed with a serious and/or life-threatening disease to access an investigational medicine for treatment outside of a clinical trial, where there are no, or no commercially available, treatment options. In such instances, a patient’s treating physician can from local regulatory authorities request access to an investigational drug prior to regulatory approval. Pharmaceutical companies may decide to make medicines available via early access pathways, however, this decision is dependent upon many factors.

TikoMed has opened an early access program for ILB®. Currently, this program is limited in geographic scope and in terms of the number of patients who may participate. This is due to factors such as the importance of maintaining the integrity of the ongoing ILB® clinical trial, the limited amount of ILB® available for use outside of the clinical trial, and the fact that TikoMed needs to ensure that it can fund and support current and future clinical trials and regulatory submissions. Bringing ILB® to market as an approved medicine to ensure that it benefits the largest number of patients will remain TikoMed’s primary focus.

Physicians seeking access to ILB® through the early access program should contact TikoMed’s Chief Medical Officer via info@tikomed.com. TikoMed will aim to respond to all requests within 3 business days. Please note that currently TikoMed is only able to satisfy a very small number of early access requests for ILB®.