Novel drugs designed to improve clinical outcomes of AIS patients will start launching from 2021
Activase (alteplase) is currently the only FDA-approved drug available for the treatment of acute ischemic stroke (AIS) in the 8MM (US, France, Germany, Italy, Spain, UK, Japan and China); however, novel drugs designed to improve clinical outcomes of AIS patients will start launching from 2021, which along with the increasing prevalence of AIS, will fuel AIS market growth.
GlobalData report, ‘Acute Ischemic Stroke: Global Drug Forecast and Market Analysis to 2027’ states that the AIS pipeline is fairly strong, consisting of around 36 pipeline candidates under development including neuroprotective agents (44 per cent), stem cell therapies (14 per cent), and drugs for stroke recovery (11 per cent). Conversely, the AIS pipeline contains only three thrombolytic drugs and very few drugs for prevention of stroke recurrence.
Dr Edit Kovalcsik, Managing Pharma Analyst, GlobalData, comments, “There is an immense socioeconomic need for reducing disability following ischemic events, which explains the fairly robust AIS pipeline. In the past two decades, AIS management has focussed on the restoration of blood flow with progress made through the extension of the therapeutic time window for Activase treatment and endovascular treatments, expanding the eligible patient population for acute treatment. “However, due to the challenges and high attrition rate that characterise the development of thrombolytic agents, no new drugs have launched, and according to the report, there are no alteplase biosimilars set to launch within the next ten years either.”
Despite demonstrating efficacy at improving survival and neurological outcome, there are still a number of AIS patients who do not qualify for intravenous alteplase. After decades of efforts, companies have finally shifted their focus towards the development of drugs that could improve clinical outcomes and restore neurological function in patients after AIS and have made some progress over the past year.
Biogen demonstrated particular commitment in 2018 to grow in the AIS space, announcing the enrollment of the first patient in the global Phase III clinical study, CHARM, to evaluate intravenous (IV) glibenclamide (BIIB093). ZZ Biotech announced some encouraging results of its pipeline candidate, 3K3A-APC, which also demonstrated substantial reduction in cerebral haemorrhage volume and incidence in AIS patients.
Despite positive results in 2018, SanBio’s regenerative cell medicine, SB623, for patients with chronic motor deficit due to AIS, unfortunately did not meet the primary endpoint of proportion of patients demonstrating at least 10 points of improvement from baseline at six months after treatment on the Fugl-Meyer Motor Scale (FMMS), compared to the placebo group in a Phase IIb trial.
Dr Kovalcsik concludes, “Despite the coming new entrants, Roche and Boehringer Ingelheim, the two companies that market Activase, are expected to maintain their leading role in the AIS space in the next decade without any threats of another thrombolytic agent or an alteplase biosimilar entering the market. Besides, new entrants are designed to be used alongside of the standard of care.”