Development of first-in-class selective plasmin inhibitor small molecules to address acute bleeding in trauma

With the combined Innovate UK and investor support, ClotProtect will advance the development of a _first-in-class_, highly selective intravenous administered anti-bleeding (anti-fibrinolytic) medicine to treat life-threatening bleeding in trauma, surgery and high-risk clinical settings. This innovation targets a critical unmet need: bleeding representing one of the **leading preventable causes of death worldwide** (6m/year globally, 16K/year within UK costing the NHS £148.3m/year in trauma-related bleeding costs).

The planned approach is truly disruptive with no current treatment directly capable of inhibiting plasmin in a selective, safe manner. The current standard of care (SoC), tranexamic acid (TXA), does not block plasmin activity directly but reduces its generation by one out of three pathways, thereby limiting its effectiveness. Whilst better than no drug, TXA only reduces death due to bleeding by one-third if administered within 3 hours of trauma; after this, mortality increases by 44%.

ClotProtects CP101 is designed to address the limitations of current treatment approaches- offering a novel small-molecule inhibitor that directly blocks plasmin activity, unlike TXA. Our preclinical data show that our drug molecules in development can provide significantly improved protection from clot breakdown (fibrinolysis) compared to TXA. ClotProtect's solution therefore has potential to significantly reduce blood loss, improve survival outcomes, minimise the need for transfusions and reduce the length of hospital stay.

The combined grant and investor funding will support chemistry optimisation of drug molecules, alongside efficacy data compared to TXA using bleeding models, and laying the groundwork for clinical translation.

Longer term, this innovation could be applied across a range of bleeding conditions, (e.g. post-partum haemorrhage, major surgery) and delivered via alternative routes. Intramuscular (i.m) delivery is particularly valuable in emergency,...