Merrion Announces Positive Clinical Results for Osteoporosis Drug MER 103
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- Published on Wednesday, 17 January 2007 02:00
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DUBLIN, Ireland and WILMINGTON, NC, USA | Jan 16, 2006 | Merrion Pharmaceuticals Ltd, an international specialty pharmaceutical company, today announced the successful completion of a clinical pharmacology study of MER 103, a novel oral formulation of alendronate sodium. MER 103 is an enteric-coated tablet of alendronate and GIPET™, Merrion’s proprietary platform technology which increases drug absorption. The study confirmed several important improvements for patient convenience and compliance relating to the administration of alendronate, the leading bisphosphonate for the prevention and treatment of osteoporosis, marketed as Fosamax® (Merck).
The study was conducted in postmenopausal women and compared the absorption of a 6mg dose of MER 103 administered to patient volunteers under three different conditions: in the fasted state, together with a high fat meal, and at bedtime, against a 35mg dose of Fosamax® administered in the fasted state as per label directions.
Subjects who received 6mg MER 103 after an overnight fast absorbed approximately twelve times more alendronate on a dose adjusted basis than when they received 35mg of Fosamax® under the same conditions. In practice, these data indicate that a 6mg weekly dose of MER 103 will be bioequivalent to a 70mg weekly dose of Fosamax®.
Subjects who received MER 103 at bedtime, approximately 4 hours after the evening meal, absorbed the same amount of alendronate as they did when taking the drug after an overnight fast. Subjects were instructed to lie down for at least 2 hours after taking their medication rather than to remain upright per the dosing instructions for the marketed oral bisphosphonates. There were no serious or clinically significant adverse events in this treatment group. The study also showed that, as with all bisphosphonate drugs, co-administration with food reduced the absorption of MER 103, although the percent drug absorbed was still greater than for the Fosamax® dose.
“The results of this clinical trial are very encouraging. The combination of improved bioavailability and the elimination of the morning dosing ritual addresses directly two of the major limitations of oral bisphosphonates. Compliance with the morning dosing ritual is a major issue in treating osteoporosis. Merrion’s improvements in this therapy constitute a significant advance,” said Michael McKenna, CEO of Merrion. “We are very pleased with the trial results and look forward to discussing these results and the further clinical development of MER 103 with prospective collaborators.”
Osteoporosis, a skeletal disorder characterized by weakened bones leading to an increased risk of fracture, is a major cause of disability and death. It contributes to an estimated 300,000 hip fractures in the US each year. Thirty three percent of women and 20% of men over the age of 50 will experience a fracture at the hip, spine or wrist in their lifetime. Ten million people in the US are estimated to have osteoporosis and 34 million more have low bone mass, placing them at greater risk for fracture. Bisphosphonates are the most commonly prescribed class of drugs for the prevention and treatment of osteoporosis. The bisphosphonate market is $6 billion and growing rapidly. However, poor adherence to therapy is a key market dynamic. Sixty percent of patients taking weekly bisphosphonates discontinue therapy within the first year, primarily due to difficulty in complying with the morning dosing ritual.
Merrion’s Gastrointestinal Permeation Enhancement Technology (GIPET™) is a clinically proven platform technology for the oral delivery of many poorly permeable compounds, with resultant improvements in patient compliance, safety and efficacy.
In all more than 20 different drugs, including small organics, peptides, and other macromolecules have shown substantial improvement in oral bioavailability with GIPET™. Merrion’s model allows rapid and low cost screening of several GIPET™ formulations to select the optimal form for further development. The leading GIPET™ enhancer matrices enjoy food additive status (GRAS) and are normal dietary components with long records of safe use. Clinical safety data for GIPET™ show that all GIPET™ treatments were well tolerated and no treatment-related adverse events were recorded.
Established in 2004, Merrion Pharmaceuticals (www.merrionpharma.com) is a privately held international specialty pharmaceutical company engaged in the development of improved oral dosage forms of drugs that have poor bioavailability, including injectable drugs, certain existing oral drugs and large molecule drug candidates. Merrion’s drug delivery technologies increase bioavailability by improving absorption in the gastrointestinal, or GI, tract, thereby enhancing efficacy, reducing side effects and improving drug tolerability. Merrion’s primary focus is on developing patentable improved oral therapeutics that can replace injectable drugs, thereby increasing physician and patient acceptance. Merrion holds more than 25 issued and in-process patents for the delivery of a variety of drugs and biologics based on our patented GIPET™ and GIRES™ drug delivery platforms. Merrion has operations in Wilmington, NC and Dublin, Ireland.
SOURCE: Merrion Pharmaceuticals Ltd