Respiratory disease represents a global healthcare challenge — and a significant opportunity for innovation.

Respiratory diseases are among the leading causes of morbidity, mortality and healthcare utilisation worldwide. Chronic respiratory diseases alone affect approximately 569 million people globally and are responsible for around 4.2 million deaths every year. Among these conditions, COPD represents one of the greatest unmet clinical and economic needs. A progressive and heterogeneous disease characterised by persistent airflow limitation, chronic respiratory symptoms and recurrent exacerbations, COPD is already the world’s third leading cause of death, accounting for approximately 3.4 million deaths in 2023 — around 6% of all deaths globally. The impact of COPD extends far beyond mortality. The disease drives substantial hospitalisations, emergency-department visits, long-term treatment and healthcare expenditure. In the US alone, COPD-attributable medical costs were estimated at approximately US$31.3 billion in 2019 and are projected to reach US$60.5 billion by 2029. As the global population ages and environmental exposures persist, the number of people living with progressive respiratory disease — and the associated burden on healthcare systems — is expected to continue to grow.

This growing burden, together with significant unmet clinical need, highlights the urgent need for new approaches to respiratory medicine. Our goal is to develop innovative, differentiated therapies that target the underlying biology of respiratory disease, with the potential to improve outcomes for patients and reduce the growing burden on healthcare systems.

  • COPD and Unfractionated Heparin (UFH)

    Our lead programme, HT-231, is a proprietary nebulised unfractionated heparin (UFH) formulation designed to deliver heparin directly to the lungs, targeting multiple biological drivers of respiratory disease.

    Severe respiratory infections and COPD exacerbations are driven by a complex interplay of inflammation, mucus obstruction, epithelial injury, infection and local thrombo-inflammation. Current treatments often target individual components of this disease cascade. HT-231 is designed to address several of these mechanisms simultaneously by harnessing the established biological activities of heparin.

    These activities include anti-inflammatory effects, through modulation of neutrophils, selectins, proteases, complement and inflammatory signalling; mucolytic and airway effects, with the potential to reduce mucus burden and airway obstruction; anti-infective and host-pathogen effects, through interactions with pathways involved in viral and bacterial disease; and local anti-thrombo-inflammatory activity, targeting coagulation and inflammatory processes within the lung. This multi-target mechanism of action creates the potential for HT-231 to complement existing standards of care across a range of respiratory conditions. HT-231 is being developed specifically for pulmonary delivery, with the objective of achieving high local exposure in the airways and alveolar spaces while limiting systemic anticoagulant exposure.

    A purpose-designed inhaled formulation and delivery system may also overcome limitations associated with the off-label use of injectable heparin, including variability in nebulisation performance, delivered dose, administration time and lung deposition. The rationale for pulmonary heparin is supported by a growing body of clinical evidence across COPD, asthma, acute lung injury and viral respiratory disease. Randomised clinical studies have reported improvements in measures including lung function, oxygenation and respiratory outcomes. In addition, an international randomised meta-trial of nebulised UFH in hospitalised, non-intubated patients with COVID-19 reported reductions in intubation or death and mortality, with no pulmonary or systemic bleeding events reported in the nebulised-heparin group. Importantly, clinical experience to date provides encouraging support for the feasibility and safety of inhaled heparin, while highlighting the need for a controlled, purpose-built respiratory product. Heparin also has a long-established history of manufacturing, clinical use and regulatory experience, providing a strong foundation for further development. Heparin Therapeutics aims to build on this established foundation with HT-231 — a proprietary, purpose-designed inhaled formulation engineered for controlled pulmonary delivery. Our objective is to transform a well-known molecule into a new class of locally acting respiratory therapeutics, addressing significant unmet needs across diseases where inflammation, mucus, infection and thrombo-inflammation intersect.

    HT-231 represents an opportunity to unlock the broader therapeutic potential of heparin — starting in the lung.