Arena Pharmaceuticals Initiates a Phase 2 Clinical Trial of APD334, its S1P1 Receptor Modulator for Autoimmune Diseases
"Important goals of pharmacotherapy for ulcerative colitis are to induce and maintain remission while improving the patient's quality of life, and, based on the results from our Phase 1 program, we believe APD334 has the potential to achieve these goals," said
This 12-week, three-arm, double-blind, placebo-controlled Phase 2 trial will enroll approximately 240 patients with moderate to severe ulcerative colitis. The primary endpoint of the trial is clinical remission. Continuation of treatment to 52 weeks will be offered to participants in a separate long-term extension study.
Arena previously completed a Phase 1 program for APD334 that demonstrated a dose-dependent effect on lymphocyte count lowering in blood. A multiple-ascending dose, Phase 1 clinical trial showed mean decreases from baseline in lymphocyte counts up to 69% and recovery on average to baseline within one week of drug discontinuation. There was a modest impact on heart rate, but none of the changes were classified by the investigator as clinically significant. There were also no findings with respect to pulmonary function or liver enzyme tests that were classified by the investigator as clinically significant.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease that affects the large intestine. The innermost lining of the large intestine becomes inflamed and ulcers may form on the surface, which can cause symptoms such as frequent bowel movements, diarrhea and bloody stools. The inflammation is usually found in the rectum and can include all or a portion of the colon. Currently available treatment options have limitations in terms of side effects, patient response, efficacy and administration. Arena believes that an effective, orally available S1P1 receptor modulator that provides clinical benefits without current limitations has the potential to improve treatment for patients with ulcerative colitis.
APD334 is a potent and selective, orally available investigational drug candidate that targets the S1P1 receptor. Discovered by Arena, APD334 has therapeutic potential in autoimmune diseases such as ulcerative colitis. S1P1 receptors have been demonstrated to be involved in the modulation of several biological responses, including lymphocyte trafficking from lymph nodes to the peripheral blood. By isolating subpopulations of lymphocytes in lymph nodes, fewer immune cells are available in the circulating blood to effect tissue damage.
Arena embraces the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's focus is discovering, developing and commercializing drugs to address unmet medical needs, and BELVIQ® (lorcaserin HCl) is Arena's first internally discovered drug approved for marketing. Arena's US operations are located in
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the advancement, investigation, therapeutic indication, use, safety, efficacy, mechanism of action, significance and potential of APD334, including relative to other therapies; the protocol, design, scope, enrollment, expectations and other aspects of the Phase 2 trial of APD334; the importance of goals related to pharmacotherapy for ulcerative colitis and the potential of APD334 with respect to such goals; APD334's utility for a variety of autoimmune diseases; the potential of an effective, orally available S1P1 receptor modulator; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arena's focus, plans, goals, strategy, expectations, research and
development programs, and ability to discover and develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: APD334 may not be developed, approved for marketing or commercialized for any disease or condition; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ or lorcaserin; cash and revenues generated from BELVIQ, including the impact of competition; the risk that Arena's revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement
regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and lorcaserin may not be approved for marketing in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arena's business prospects; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data
differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena's research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; Arena's and third parties' intellectual property rights; the timing, success and cost of Arena's research and development and related strategy and decisions; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and
satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the
Operations & Head of Global Regulatory Affairs
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