Palau Pharma Initiates A Phase II Clinical Trial Of Dersalazine Sodium In Mild To Moderate Ulcerative Colitis
The study is a Phase II multi-centre, randomized, double blind, parallel group, two placebos and active reference controlled study of the safety and activity of dersalazine sodium when administered to patients with active, mild to moderate, UC. Eighty (80) subjects will be studied in three parallel groups (dersalazine sodium, mesalazine and placebo), with a randomization of 2:1:1. Each subject will receive doses of dersalazine sodium, placebo or mesalazine twice daily for 4 weeks. The study will be conducted in 4 European countries and in 16 investigational sites.
This study represents the first investigation of dersalazine sodium in UC patients and has been designed to obtain initial information on the safety, tolerability and activity of the product in patients before a full length treatment is given in a clinical setting.
A successful randomized, double-blind, placebo and active standard controlled Phase I study to assess the tolerability of raising multiple doses of dersalazine sodium in healthy volunteers was completed during 2008. This was designed to assess the safety and tolerability of four rising oral dose levels given twice daily during 14 days to healthy male subjects.
UC is a chronic, relapsing inflammatory disease that affects the colon. It is estimated to affect one in 1000 people in the Western world . Ulcerative colitis treatments aim to suppress the acute inflammatory process during the disease flare (acute treatment) and to limit the occurrence of new flares (maintenance treatment). Current therapies for mild and moderate disease rely mainly on aminosalicylates, but often efficacy is limited to short-term use. Resistant or more severe disease can be treated with corticosteroids, immunosuppresants or anti-TNF? agents. However, adverse effects, inconvenience and high cost limit their long-term use.
Dersalazine sodium is a new chemical entity that was designed by Palau’s scientists as the result of linking a potent anti-TNF? agent (UR-12715) with 5-aminosalicylic acid (5-ASA) by an azo bond. Dersalazine sodium is carried unaltered through the upper gastrointestinal tract until azo-reduction by the colonic bacteria, initiating the release of both active compounds in the colon, where they act as topical anti-inflammatory agents. By linking UR-12715 with 5-ASA, the release of UR-12715 directly to the inflamed mucosa is enhanced and potential systemic effects are minimized. If proven clinically active and safe, dersalazine sodium may constitute a landmark in the treatment of UC.
“We are delighted to announce the enrollment of the first patient in this phase II trial. Dersalazine sodium has the potential to address the issues associated with the long term use of current ulcerative colitis treatments utilizing a new approach in the application of well profiled 5-aminosalicylic acid,” commented Ignacio Faus, Chief Executive of Palau Pharma. “Following our strategy for this project, after completion of this study, we will seek a license partner for the further worldwide development and commercialization.”
About Palau Pharma
Palau Pharma, S.A. is a product-driven specialty pharmaceutical company focused on the discovery and development of innovative, improved and safer medicines for the treatment of inflammatory and autoimmune diseases. Palau was formed in 2006 as a spin-out from Spanish pharmaceutical company Grupo Uriach, where the team had been responsible for the discovery, development and launch of marketed drugs such as the antihistaminic agent Rupafin® (INN rupatadine). Palau’s pipeline consists of 10 projects addressing diseases such as asthma, allergic rhinitis, psoriasis, ulcerative colitis, rheumatoid arthritis and atopic dermatitis, five of which are currently being developed by our international partners. Palau raised €40 M on its inception from institutional investors that include Caja Duero, Andosins Capital, Caixa Catalunya and Najeti Capital.