Japan’s Daiichi Sankyo has boosted its thrombosis pipeline by licensing a novel clot-dissolving agent from US firm Translational Sciences.
The drug candidate – called TS23 – is in phase I trials but has shown “exceptional efficacy and safety in multiple disease models”, according to Memphis-based Translational Sciences.
At the moment blood clots causing diseases such as ischemic stroke, heart attack and acute peripheral vascular ischaemia are generally treated with an injection of tissue plasminogen activator (tPA) products such as Genentech/Boehringer Ingelheim’s Activase/Actilyse (alteplase), but Translational Sciences believes there is significant room for improvement.
tPA is the only effective, FDA-approved treatment for ischemic stroke, for example, but is associated with significant risks, delays in treatment and is unsuccessful in up to 70% of patients, leading to death and disability.
Meanwhile, anticoagulants such as warfarin and the newer novel oral anticoagulant (NOAC) class can prevent clots from forming but are unable to dissolve them when already present.
Translational Sciences maintains that its antibody bypasses many of the limitations of TPA and has the potential to be a safer, more effective therapy that allows “early treatment, saves lives, reduces disability and lowers healthcare costs.
“TS23 inactivates a2-antiplasmin (a2AP) – a major inhibitor of clot-dissolving enzyme plasmin – and dissolves clots through a unique mechanism that according to the company “avoids the risk of haemorrhage and neurotoxicity associated with TPA therapy.
“The Memphis company has already garnered around $5m in funding via the US government’s Small Business Innovation Research (SBIR) programme, and with Daiichi Sankyo on board will now have the financial backing to accelerate the clinical development of TS23.
The Japanese drugmaker is already a major player in the thrombosis market with products such as Eli Lilly-partnered antiplatelet drug Effient (prasugrel) and recently-introduced NOAC Lixiana (edoxaban).
“This agreement … is in line with the Daiichi Sankyo R&D strategy to expand its portfolio in the prevention and treatment of thrombosis,” said the company in a statement.
It will pay Translational Sciences unspecified fees, milestones and royalties for exclusive rights to globally develop and commercialise TS23.