AbilityPharma receives WHO approval for its ABTL0812 anticancer drug to be named IBRILATAZAR

AbilityPharma announces that the World Health Organization (WHO) has recommended ABTL0812, a first-in-class oral drug for cancer treatment that causes selective death of cancer cells through autophagy as a new therapeutic strategy, to receive the International Non-proprietary Name (INN) of ibrilatazar. The ABTL0812 name used so far pertains to AbilityPharma's internal code for this investigational product.

Ibrilatazar has shown in preclinical and clinical trials an excellent safety, tolerability and efficacy profile in adult patients with metastatic pancreatic, lung and endometrial cancer.

AbilityPharma is currently conducting a multicenter, double-blind, placebo-controlled Phase 2b clinical trial in metastatic pancreatic cancer to demonstrate increased efficacy of ibrilatazar compared to current standard treatment FOLFIRINOX (chemotherapy). The study includes reference centers in Spain, the United States, France and Israel.

In a Phase 2a clinical trial, the combination of Ibrilatazar with chemotherapy has been shown to double lung cancer patients’ survival compared to historical controls with chemotherapy alone. The results were presented at the prestigious annual American Society of Clinical Oncology (ASCO) Meeting in 2023.

Ibrilatazar has also achieved positive efficacy results in a Phase 1/2 clinical trial in patients with endometrial cancer. The study shows that the triple combination of ibrilatazar with carboplatin and paclitaxel chemotherapy is active and could become a new first-line treatment.

In preclinical models, Ibrilatazar is effective as a single agent with an excellent safety profile in a broad spectrum of cancer types (pancreas, lung, endometrium, neuroblastoma, bile ducts and glioblastoma).

The results of these studies can be consulted in the "Publications" section of this website.

Ibrilatazar has orphan drug designation for pancreatic cancer, biliary cancer, and pediatric neuroblastoma from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the United States.

International Nonproprietary Name (INN)

International Nonproprietary Names (INNs) identify active pharmaceutical substances or pharmaceutical ingredients and are granted by the WHO. Each INN is a unique, globally recognized name and is publicly owned. An INN is also known as a generic name.

Since its inception in 1950, the goal of the INN system has been to provide healthcare professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature of pharmaceutical substances, in the form of INNs, is important for clear identification, safe prescription and dispensing of medicines to patients, and for the communication and exchange of information between health professionals and scientists around the world.