Ablynx, a biopharmaceutical company engaged in the discovery and development of nanobodies, has initiated pre-clinical development of its anti-IgE Nanobody, ALX-0962, for the treatment of severe allergic asthma, with the goal of commencing phase I clinical development in the second half of 2014. ALX-0962 consists of a highly potent anti-IgE Nanobody with a unique dual mode of action (which refers to its ability to bind with high affinity to IgE while also displacing receptor-bound IgE), together with a serum albumin binding Nanobody for in vivo plasma half-life extension.
ALX-0962 has been designed to be a potential best-in-class, next generation biologic for the treatment of severe allergic asthma with important potential benefits over available treatment options.
Due to the Nanobody's potency and dual mode of action, Ablynx believes that ALX-0962 could address a wider patient population, including those currently not eligible to be treated with omalizumab (Xolair) because of their high IgE to body weight ratios. Furthermore, ALX-0962 has the potential to exhibit a better safety profile, have a faster onset of action and offer more convenient dosing regimens.
Dr Edwin Moses, chairman and CEO of Ablynx commented: "We are very pleased to have initiated pre-clinical development of our anti-IgE Nanobody, which we expect to enter the clinic in the second half of next year. Severe allergic asthma is an important condition and represents a substantial segment of the total asthma market that currently has a total value of $14.7 billion. Due to the Nanobody's unique and dual mode of action, we believe ALX-0962 could take an important share of this very large market not least by offering a treatment option to patients not eligible for currently available IgE inhibiting drugs."
ALX-0962 is a monovalent 26kD Nanobody which incorporates Ablynx's proprietary plasma half-life extension technology targeting serum albumin. It has a unique dual mode of action in which it binds with high affinity to immunoglobulin E (IgE) as well as displacing receptor bound IgE. As a result, it is a very potent inhibitor of the biological effects exerted by IgE. Its high solubility allows for convenient subcutaneous administration. ALX-0962 has been developed with the potential to treat a broader population of patients suffering from asthma in a more effective and more convenient way compared to currently available therapies.
IgE is a hallmark for allergic disease and a key mediator to initiate an allergic reaction upon allergen exposure. IgE titres (total and allergen specific) are used to diagnose and stratify allergic asthma patients as well as to guide their treatment choice. Neutralising IgE is a clinically and commercially validated mechanism to treat allergic asthma. Omalizumab (marketed as Xolair by Roche and Novartis) currently is the only anti-IgE biologic approved for the treatment of patients with moderate to severe persistent allergic asthma, inadequately controlled with inhaled corticosteroids. Xolair generated sales of $1.26bn in 2012.
Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease.