Basel, Switzerland – 28 February 2023

Rare Disease Day takes place annually on the last day of February to raise awareness for the more than 7,000 rare diseases and their impact on patients’ lives. Physicians, patients, patient advocates, researchers and medical & biotech companies from around the world shine a light on these little-known diseases and champion the need for education, research funding and access to treatment.

Alentis has chosen to spread the word through a team event showing support for patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Glomerulonephritis and Idiopathic Pulmonary Fibrosis (IPF).

ANCA-Associated Glomerulonephritis is an autoimmune disease affecting the filters in the kidney. The autoantibodies called ANCAs attack the small blood vessels in the filters and can damage them causing inflammation and scarring that can lead to kidney failure and the need for dialysis or even a kidney transplant. There is no cure; treatment focuses on remission and maintenance therapy.

Alentis Therapeutics is developing breakthrough treatments based on anti-Claudin 1 (CLDN1) monoclonal antibodies (mAb) for CLDN1+ tumors and fibrotic diseases. ALE.F02 is a highly selective anti-CLDN1 mAb that recognizes pathological overexpressed and conformation-dependent CLDN1 epitopes and is being investigated for the treatment of fibrotic diseases in the kidney, lung and liver. Alentis plans to start recruitment for a phase 2 study in ANCA-Associated Glomerulonephritis in Q2 2023 following proven safety and tolerability in the single ascending dose arm of a phase 1 healthy volunteer study.

“More than 70,000 Americans suffer from ANCA associated vasculitis — a severe inflammatory disease that causes kidney failure, chronic suffering and shortens lives with a worse outlook than some cancers. The varied nature of patient symptoms often delays diagnosis. Standard therapies are quite toxic causing frequent side-effects — and not always effective,“ said Professor David Jayne, University of Cambridge. “Not only must physicians have a better understanding of this disease, there is also a real need for better therapies to reduce current toxic treatments and improve the chances of patient recovery — especially kidney function.“

Alentis Therapeutics is simultaneously pursuing pre-clinical development of ALE.F02 in Idiopathic Pulmonary Fibrosis to be IND ready in the second half of 2023. IPF is a serious chronic disease affecting tissue surrounding the air sacs or alveoli in the lungs, resulting in a thickening of lung tissue. Over time, this thickening causes permanent scarring of the lungs, called fibrosis, which makes breathing increasingly difficult. There is currently no cure for this condition with treatments only slowing the progression of IPF.

Professor Wim Wuyts, at KU Leuven, said, “We must find a real cure for this disease. To improve care we need to go back to the bench and improve our understanding of the key mechanisms driving the disease. IPF affects far more people than we originally thought, and it significantly impacts the quality of their lives. This remains a deadly disease notwithstanding the progress made in recent years.”