TDT is a is a chimera of “natriuretic-like” peptides found in the venoms of the Taipan and the Dendroapsis snakes.
The heart failure market is set to rise from around $3.2 billion in 2015 to $11.8 billion by 2025; (13.7% growth)
Ularitide, (Cardiorentis AG / Roche) Phase 3 development, raised US$62m in 2016, US$1.75bn market cap
- Each year, more than 30 million people suffer heart failure (HF), resulting in ~5 million hospital admissions, and a high rate of death.
- Acute Heart Failure can be defined as the sudden or gradual onset of the signs or symptoms of HF resulting in a need for urgent therapy or hospitalisation. Readmission rate of patients with HF is high, within 1 year of discharge (~25% in the US and EU, and 35% in China)
- Loop diuretics are currently the only treatment for AHF, with poor long-term outcomes
- TDT induces sodium and water excretion by binding to specific natriuretic peptide receptors (NPR-A, NPR-B), resulting in relaxation of muscle, vasodilation and increased blood flow
- TDT may improve the survival for patients with acute heart failure and reduce hospitalisation when compared with loop diuretics.
- Strong proof-of-concept data and confirmed desired pharmacology with a minimal side-effect profile that is superior to existing natriuretic peptide products
- Broad US and EU patent granted for “Proteinaceous compounds and uses therefore”
- Major pharmaceutical companies have expressed an interest in buying TDT upon successful completion of Phase 1 trials
- No observed tachycardia or other negative side effects compared with existing NPs (Ularitide is associated with hypotension and nausea/dizziness at 22ng/kg/min providing only a narrow therapeutic dose range around the recommended 15ng/kg/min)
- Highly potent molecule
- Durability of pharmacological action
- TDT is not broken down by neprilysin (more likely to have desired clinical effects)
- Higher animal models demonstrated the efficacy of TDT for the prevention of worsening cardiac function
- Daily injections of TDT resulted in significantly higher fractional shortening and LVEF compared to untreated animals.
- TDT decreased blood pressure in conscious rabbits without inducing tachycardia.