Taho Pharmaceuticals’s apixaban-based oral dissolving strips were discovered to be a bioequivalent of Pfizer and Bristol-Myers Squibb’s (BMS) Eliquis in a Phase II trial.
The randomised open-label pivotal trial (NCT06689436) enrolled 60 healthy volunteers. Of those, 48 went on to complete the trial over four arms, two who were made to fast for ten hours and the other two having been fed. One group from each was given apixaban, dubbed TAH3311, with the other two given an Eliquis tablet. Results found the maximum plasma concentration in patients dosed with TAH3311 was equivalent to Eliquis, which is approved in the US and Europe.
Taho Pharmaceuticals now plans to use these results to push ahead with a new drug application (NDA) and a marketing authorisation application (MAA) before the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA).
The company’s dissolvable strips are primarily aimed at stroke patients for whom swallowing tablets can be difficult. Research conducted by the World Stroke Organization (WSO) found that there are more than 12.2 million new strokes each year. Globally, one in four people aged over 25 will have a stroke in their lifetime.
Of those patients, some are liable to develop a condition known as dysphagia, which can prevent a patient from swallowing medications. Typically, in this case, medication is administered by crushing a tablet into water, leading to dosing inaccuracies.
Taho Pharmaceuticals CEO Howard Lee said: “This pivotal study underscores our commitment to patient-centric innovation. TAH3311 is especially valuable for stroke patients, the elderly, children or others who have swallowing difficulties and require anticoagulant therapy twice daily. We believe this novel formulation can improve patient outcomes and reduce the risk of aspiration pneumonia caused by choking when swallowing medication with water."
Market research from GlobalData estimates that in 2024 sales of Eliquis brought in more than $13.3bn, with that figure on track to drop to estimated sales of $858m by the end of 2030.
The first generic versions of apixaban were approved by the FDA in 2019, however, these will not be available for sale until 2028, which is when GlobalData’s sales forecast for Eliquis starts to drop.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of stroke care, increasing levels and intensity of heat waves have been linked with higher occurrences of ischaemic stroke (IS). Meanwhile, Basking Biosciences has dosed the first subject in the Phase II RAISE clinical trial of its lead candidate, BB-031, in patients with acute IS.
