Biotechnology giant Roche warns that multiple sclerosis drug trials are compromised in Ukraine – with patients losing access to crucial treatment
Ukraine continues to face an onslaught of violence from Russian forces, disrupting essential services across the country. Whether Ukrainians are looking for HIV treatment or diabetes management, ordinary supply chains are running into hostile obstacles.
Roche, running a multiple sclerosis drug trial across Eastern Europe, are now concerned about Ukrainians’ ability to participate.
Medical corridors fail to work when invading force ignores them
In March the World Health Organisation (WHO) attempted to create corridors for the delivery of oxygen to hospitals, which were running “dangerously low” according to WHO chief Dr Tedros Adhanom Ghebreyesus.
While humanitarian corridors are normally negotiated to allow evacuation of civilians and access to medical treatment, Ukraine is now unwilling to open any, due to safety concerns. Previous attempts at evacuation led to the indiscriminate murder of civilians by Russian forces.
Roche said that 20% to 30% of patients in the global fenebrutinib MS trial programme have so far been from Ukraine and Russia.
Individuals in clinical trials in Eastern Europe are often dependant on the treatment they gain from participation, as these drugs are at the forefront of disease management and eclipse locally available options.
Interruption in delivery of multiple sclerosis drugs can lead to significantly worse health outcomes for participants. Many participants have been forced to flee to neighbouring countries.
“Both Ukraine and Russia historically have been very important contributors to clinical trials for patients with neurological disorders such as multiple sclerosis,” said Bill Anderson, head of Roche’s pharmaceutical division, on a call to journalists on 25 April.
Fenebrutinib is one of the key multiple sclerosis drugs in clinical trial stage
This is part of a new class of drugs, known as Bruton’s tyrosine kinase (BTK) inhibitors.
BTK is a molecule that influences the activity of some immune cells, so if BTK stops working then immune cell activity is decreased. These cells have been linked to MS relapses and progression, which makes them a good target for treatment.
Scientists propose that reducing the activity of BTK cells could actually lessen the damage caused to nerves by MS. Pharmaceutical and biotech companies across the world are racing to develop BTK inhibitors right now.
According to MS Society, fenebrutinib has a reversible mechanism – which could arguably create a safer treatment for MS, in contrast to permanent BTK inhibition. If clinical trials go well, then results are due in 2025 and 2028.
Regulatory approval and cross-checking of results can take longer, which means that no drug would be available before 2030.
Roche are also testing Ocrevus drug on MS patients
The new data underlined the longer-term efficacy and safety for Roche’s new medicines Ocrevus (MS), Evrysdi (SMA) and Enspryng (NMOSD).
In an end of financial quarter update, Roche said that data for Ocrevus was looking good.
Ocrevus is a disease modifying drug for active relapsing remitting, very active relapsing remitting MS and early primary progressive MS. A patient taking this drug will have fewer relapses than if they went without treatment, with overall disease progression significantly slowed.
The drug was found to have an impact in disability progression and cognitive decline, in both secondary progressive and primary progressive MS. Roche added that they included findings from ethnic minority populations, such as Black and Latinx patients in the US.
While Roche commit to no longer recruiting clinical trial participants from Russia, Pfizer will continue to deliver drugs and treatment to the country.