Tiziana Life Sciences (Tiziana) has announced that the second patient with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown ‘additional clinical improvement’ after 11 months of treatment.
The company previously reported that in September 2022, eight months after starting treatment with foralumab, the patient walked 100 metres without a cane or need for rest. Prior to this, in June 2022, the patient required a cane to walk this same distance. This corresponds with a clinically meaningful improvement in the Expanded Disability Status Scale (EDSS) score of 0.5.
The EDSS score has now improved by a further 0.5, with the company reporting that the patient was able to walk 200 metres without a cane in December 2022, 11 months after starting treatment.
Consistent with the eight-month update, the patient’s pyramidal score remained stable and did not worsen over time.
MS is a disabling, unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The condition affects around 700,000 people in Europe and approximately 2.5 million people worldwide.
SPMS is a stage of MS which comes after relapsing remitting MS for many people. With this type of MS the patient’s disability gets steadily worse and relapses – where symptoms get worse and then get better – are unlikely.
“SPMS represents an advanced stage of MS with few treatment options and creates a severe burden on patients,” said Howard Weiner, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital and chairman of Tiziana’s Scientific Advisory Board.
The company announced in November last year that it had completed the enrolment of the first patient cohort in its intermediate size patient population expanded access programme to evaluate foralumab in non-active SPMS patients.
The Massachusetts-based treatment programme will evaluate dosing at the ‘standard’ 50mcg dose and, if needed, a higher 100mcg dose of intranasal foralumab in two separate cohorts of four non-active SPMS patients each.
“Six patients are currently enrolled and are being followed in our intranasal foralumab programme,” said Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana. “[The second patient’s] clinical improvement justifies Tiziana’s decision to make intranasal foralumab for non-active SPMS our top priority.”