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Kemia Announces Completion of Phase I Trials for Oral Anti-Inflammatory Drug; KC706, a P38 MAP Kinase Inhibitor, Targets Inflammatory Conditions Including Arthritis, Psoriasis, and Cardiovascular Disease

Posted on: Wednesday, 23 August 2006, 12:00 CDT

Kemia announced today that the company has completed initial Phase I clinical trials with KC706, a novel oral anti-inflammatory drug that works by selectively and allosterically inhibiting p38 MAP kinase. Based on these successful Phase I trials, Kemia now plans to evaluate KC706 in several diseases characterized by chronic inflammation. The first Phase IIa clinical trial, treating patients suffering from rheumatoid arthritis, will commence at the end of September.

"We are pleased with the clinical profile that is emerging for KC706," said Lew Shuster, Kemia's CEO. "We are excited about the prospects of Kemia's first new medicine, which was designed and synthesized in Kemia's drug discovery group and then brought through Phase I trials by Kemia's development team. We will be aggressively pursuing its continued clinical development with our upcoming Phase II trials."

An initial escalating single-dose study in healthy human volunteers showed that KC706 was well tolerated. A second, escalating multiple-dose study evaluated the human pharmacokinetics of KC706 and demonstrated the safety of a range of doses to be used in Phase II clinical trials. A third Phase I trial confirmed the bioavailability of a capsule formulation to be used in future trials. A total of 79 healthy volunteers have received the drug to date. One assay conducted as part of the Phase I trials confirmed that KC706 was providing a long-acting, dose-dependent anti-inflammatory effect.

KC706 may hold the potential to treat inflammatory conditions such as rheumatoid arthritis, psoriasis, asthma, chronic obstructive pulmonary disorder, and certain metabolic and cardiovascular diseases. The company will shortly commence enrolling a placebo-controlled Phase IIa clinical trial in Europe in 150 patients with rheumatoid arthritis. The safety and efficacy of two doses of KC706 will be evaluated over a 12-week dosing period in patients who have evidence of active rheumatoid arthritis in spite of ongoing therapy with methotrexate. The company is now planning another Phase IIa trial to explore the potential for KC706 in a second disease area.

Kinases are key regulatory proteins in important biological pathways such as inflammation. Kemia's chemistries represent a "next generation" approach in contrast to the majority of earlier generation kinase inhibitors that directly compete for ATP binding. Kemia believes that the allosteric inhibitors developed by Kemia offer improved selectivity compared to first generation ATP competitive compounds and thus should reduce the risk of side effects from off-target interactions.

KC706 is a selective, allosteric p38 MAP kinase inhibitor. The p38 protein is an important signaling molecule in inflammation. High levels of p38 activity have been associated with several inflammatory diseases. Additionally, the allosteric binding of KC706 to p38 MAP kinase results in a much longer duration of action compared to traditional ATP-competitive kinase inhibitors. This extended binding with the target protein provides the potential for once-daily dosing to have a more sustained therapeutic effect.

In addition to the oral KC706 program, Kemia is exploring additional formulations of the KC706 including a topical formulation to treat psoriasis. Other, earlier stage programs at the company include inhibitors of CCR5 for the treatment of HIV and inflammatory conditions and amylin receptor agonists for the treatment of obesity and diabetes. Kemia's amylin receptor agonists are non-peptide small molecules with the future potential for oral dosing. In animal models, they slow gastric emptying and decrease food intake similarly to the injectable hormone they are designed to mimic. Kemia believes the longer duration of action of a small molecule drug should result in a superior weight loss benefit to patients.

About Kemia, Inc.

Kemia discovers and develops novel small molecule therapeutics. Kemia focuses on high value disease targets that are validated, but not yet addressed by safe and effective non-injectable drugs. Kemia's competitive advantage includes proprietary chemistries for allosteric inhibition of kinases and for modulation of GPCRs (G-protein coupled receptors), a multi-disciplinary approach to medicinal chemistry, and rigorous ADME and pharmacokinetic evaluation integrated into the lead optimization process. For more information about Kemia please visit www.kemia.com.

NOTE TO EDITORS: In the company name Kemia Inc. noted in this news release, there is an accent over the "e" in "Kemia."

Source: Business Wire

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