Our Phase IIa clinical trial evaluating the safety, tolerability and possible efficacy of subcutaneous injections of ILB® in ALS is finalized and has been reported to the Swedish Medical Products Agency.
The results indicate that, for the variants of ALS and the given dose investigated in the study, ILB® seems to have beneficial clinical effects without significant side effects.
A clinical program involves four phases (I-IV) where each phase is designed to provide investigational study answers while ensuring necessary safety precautions for the study participants. All trials are also conducted according to Good Clinical Practice (GCP) guidelines that regulators require in order to protect patient safety.
Given these positive yet still very early phase II results for ILB®, we remain fully committed to our ongoing clinical development program aimed at collecting the necessary safety and efficacy information required for regulatory authorities.
We intend to post new information on our website as soon as we have more to share.