The Medicines and Healthcare products Regulatory Agency in the United Kingdom has granted permission to Tikomed to begin a Phase 2 clinical trial to evaluate the safety and effectiveness of ILB, an investigational therapy for amyotrophic lateral sclerosis (ALS).
The trial will take place at Birmingham University Hospital in Birmingham, U.K., with Venkataramanan Srinivasan, MD, as the principal investigator.
Set to begin in the coming months, the trial will recruit 15 ALS patients who will be given ILB over a 10-week period.
“We are very pleased that the UK Medicines and Healthcare products Regulatory Agency has granted us permission for our phase II clinical trial for patients with ALS,” Anders Svenson, MD, chief medical officer of Tikomed, said in a press release. “With this decision, we continue to deliver on our clinical roadmap and we strongly believe that this clinical trial, to be conducted at Birmingham University Hospital, will demonstrate the safety and tolerability of ILB in the treatment of ALS.”
In addition to the U.K. trial, Tikomed will be conducting a parallel Phase 2 trial (NCT03613571) with Sahlgrenska University Hospital in Sweden. In this trial, which is not yet recruiting, 15 ALS patients will be enrolled and given ILB via five weekly subcutaneous (under the skin) injections.
Study participation will be four months, including the screening and three follow-up visits. The trial’s primary objective is to evaluate the safety and tolerability of ILB.
ILB is described as a pleiotropic molecule, meaning it produces more than one benefit. It is designed to reduce the signals that lead to cell death, high levels of which are characteristic of several neurological diseases including ALS.
According to the company, ILB, among other effects, normalizes mitochondrial function (energy production), blocks the damaging formation of plaques, and increases formation of new blood vessels.
Prior clinical studies have shown that ILB is safe and well-tolerated when administered intravenously (into the bloodstream) with only minor adverse events and no severe adverse events.
Because ILB is tackling an underlying problem of the disease and not just treating the symptoms, it has the potential to significantly improve outcomes of ALS patients.
“ALS is a debilitating disease with no cure and as current treatment options focus on slowing the progression of the disease, we are excited about ILB’s unique mechanism of action of triggering self-repair and protection. We are hopeful that this might present new possibilities for both patients and caregivers impacted by this terrible disease,” said Anders Kristensson, CEO of Tikomed.
Sweden-based Tikomed is a specialty biopharmaceutical company focused on the development of therapies for acute and degenerative neurological and ophthalmic (eye) diseases.