Recipient organisationNIHR Imperial Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Ongoing
In plain English
AI plain-English summary
A drug called APL-9796 is being tested in people with pulmonary hypertension to see if it can slow a protein that stiffens lung arteries. Pulmonary hypertension is a rare condition where the walls of the pulmonary arteries become thick and rigid, forcing the heart to work harder and leaving patients breathless, exhausted, and prone to fainting. Current treatments are limited. This trial targets a protein called ZIP12, which is overproduced in tissue samples from patients. Animal studies suggest that blocking ZIP12’s activity can reverse artery stiffening. If APL-9796 proves safe and effective, it could offer a new treatment option for a disease with few alternatives, potentially improving daily life for patients who now struggle with simple activities like walking or climbing stairs. The trial uses implanted pressure sensors to measure the drug’s effect precisely, which may also reduce the need for invasive procedures in future studies. This is a phase 2 trial, so the immediate goal is safety and dosing, not a cure—but success would open the door to larger trials and, eventually, a new therapy for a condition that currently has no cure.
View original technical description
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.
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