A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants with Pulmonary Hypertension (ViTAL-PH)

Pulmonary hypertension (PH) is a rare condition that causes high blood pressure in the pulmonary arteries. The walls of the pulmonary arteries become stiff and thickened, reducing blood flow and making it harder for the right side of the heart to pump blood through the arteries. Patients with PH typically experience shortness of breath, tiredness, chest pain, feeling dizzy or fainting. The AP13CP02 study is a UK-only, phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (under the skin) injections of APL-9796 are for patients with PH. The study will also assess how effective APL-9796 could be for treating patients with PH and whether the body produces antibodies working against APL-9796. APL-9796 binds to a protein called ZIP12 and slows down its activity. In animal studies, blocking the production and function of the ZIP12 protein has shown therapeutic potential for PH. As tissue samples from patients with PH have shown increased levels of ZIP12 production, it is thought that slowing down ZIP12 activity may also be beneficial to PH patients. The trial will be conducted in two parts: • Part A: Up to 36 adults with WHO Group 1 Pulmonary arterial hypertension (PAH). • Part B (optional): Up to 12 adults with WHO Group 3 - PH secondary to interstitial lung disease (PH-ILD). Only patients who are pre-implanted with the CardioMEMS™ pulmonary artery pressure sensor will be enrolled. The recruitment of PH patients with these devices enables a more precise assessment of the therapeutic effect of APL-9796 and may permit the determination of safe and effective doses of APL-9796 while limiting both the number of participants and the need for more invasive procedures. The trial duration will be approximately 18 months for each participant. Three APL-9796 dose levels are planned for evaluation.