Serono plans multiple sclerosis treatment by inhalation
multiple sclerosis franchise with a new version of interferon beta
that would do away with the need for injections, reports Phil
Taylor.
The company already sells an injectable drug for MS, Rebif (interferon beta 1a) and has small molecule, orally active drugs in its pipeline. These could now been joined by an inhaleable formulation that would provide a more patient-friendly alternative to the current injectable drugs for MS, and could improve efficacy.
In order to develop the new product, Serono has signed a partnership with US company Syntonix Pharmaceuticals to develop the inhaled interferon beta using a technology that improves the transport of the protein across the epithelial lining of the lungs.
Syntonix' approach relies on the joining of the therapeutic protein to a small part of an antibody, called the Fc fragment, that binds to receptors on epithelial cells. The resulting fusion protein crosses the cellular lining more readily than the therapeutic protein alone. In addition, the fusion proteins are recirculated in the body, delaying their breakdown and extending their half-life, which could potentially boost efficacy and reduce dosing frequency. Serono's drug is administered three times weekly via subcutaneous injection, which is burdensome for the patient.
In in vivo experiments … a proprietary interferon-beta:Fc molecule produced by Syntonix exhibited pharmacokinetic and pharmacodynamic properties that justify further development," said the companies in a statement.
Under the terms of their partnership, Serono has licensed worldwide exclusive rights to Syntonix' Fc-based echnologies, developed under the Transceptor and Synfusion badges, for the development and commercialisation of interferon-beta:Fc products.
Rebif is the top-selling interferon drug for MS outside the US, where Biogen Idec is the leader with its Avonex brand, and brought in $1.1bn (€848m) in global sales last year.
Meanwhile, Syntonix' Fc technologies are applicable not only to inhaled delivery but also intranasal and oral administration. The company is aiming to use its technology to increase the therapeutic window for drugs with either short half-life (e.g. peptides) or significant dose-limiting side effects (e.g. interferon alpha).
The US firm also has a collaboration in place with Dyax Corp relating to the discovery of new drugs for autoimmune and inflammatory disorders.
