|XOMA Offers Update on Gevokizumaba; Celladon Completes Enrollment of CUPID 2 Trial|
|By Staff and Wire Reports|
|Tuesday, 04 March 2014 20:45|
XOMA Corporation (Nasdaq: XOMA), a leader in the discovery and development of therapeutic antibodies, provided an update on its gevokizumab development program. Based on results from the Company's Phase 2 program in patients with erosive osteoarthritis of the hand (EOA), XOMA does not intend to launch pivotal development for the broad EOA indication. The Company will conduct a review of the full dataset to determine if there is a segment of the patient population that best responds to gevokizumab therapy prior to initiating any potential additional clinical studies in this indication. Gevokizumab appeared to be well tolerated, and the most common adverse events were comparable between both the gevokizumab and placebo groups. XOMA will continue to focus its efforts on completing the EYEGUARD™ Phase 3 clinical program, preparing to initiate its Phase 3 program in patients with pyoderma gangrenosum (PG), and assessing gevokizumab in pilot studies of other rare diseases that are in need of new therapeutic options.
"We launched our proof-of-concept program for gevokizumab just over two years ago. We developed a thoughtful plan that would allow data derived from well-designed clinical studies using gevokizumab to lead us to the best opportunities to follow our ongoing Phase 3 studies in non-infectious and Behçet's uveitis. While we are disappointed in today's results, the new information we received from these Phase 2 studies informs our next decisions. The data we generated in our erosive osteoarthritis of the hand studies enabled our decision not to initiate large Phase 3 studies for this indication. In contrast, the data that we generated last fall in pyoderma gangrenosum allowed us to select this orphan indication as our next Phase 3 effort," stated John Varian, Chief Executive Officer of XOMA. "The data Servier and we are generating in six additional indications we have disclosed, as well as other indications we haven't yet disclosed, will continue to light our pathway forward."
XOMA conducted two separate double-blind, placebo-controlled clinical studies in patients with EOA. The first study (Study 160) enrolled 85 patients who were diagnosed with EOA and who had a high-sensitivity C-reactive protein (CRP) level ≥2.5 mg/L. CRP is recognized as a biomarker for generalized inflammation. The second study (Study 162) enrolled 92 patients who met the criteria for the first study but did not have elevated CRP. In both studies, patients were randomized 2:1 to receive either gevokizumab 60mg or placebo, dosed subcutaneously once monthly. Both studies were designed to determine if gevokizumab could improve the pain, stiffness, and physical function associated with EOA, based upon the Australian/Canadian Osteoarthritis Hand Index (AUSCAN™) scoring scale. AUSCAN is a validated self-administered questionnaire specifically designed to assess the three dimensions of pain, disability, and joint stiffness of osteoarthritis of the hand using a series of 15 questions. Study 160 assessed the change in AUSCAN score from baseline at Days 84 and 168 in addition to assessing improvements of the effected joints from baseline using radiographic and MRI images taken at Days 84 and 168. Study 162 assessed the change in AUSCAN score from baseline at Day 84, the results in the second study did not show the same strength as the Day 84 results from Study 160.
The initial results from Study 160 showed separation between the gevokizumab and placebo scores favoring gevokizumab over the 84-day period. While the gevokizumab-treated patients continued to show an improvement in all AUSCAN measures over their baseline scores after 168 days of therapy, the placebo treated patients showed a greater improvement over the final three months of the study, eliminating the separation seen between placebo and actively treated patients by the Day 168 time point. The Company's primary analyses and other objective measures, such as MRIs and radiographs, did not suggest a significant drug-related benefit after six months.
XOMA has begun analyses of relevant patient subgroups, and these data have shown placebo response was driven by patients with milder disease at baseline. Comparisons of patients with more severe pain (visual analog scale ≥ 75/100) at baseline show a consistent trend favoring gevokizumab in all components of their AUSCAN scores. In both proof-of-concept studies, gevokizumab demonstrated a statistically significant effect on CRP levels over the full study periods. It is possible these observations, as well as further analyses, could provide a reasonable group to study in future trials but it is too early to tell at this point.
Gevokizumab was generally well tolerated, and there were no drug-related serious adverse events reported in these studies. The most common adverse events were headache, pain, arthralgia, urinary tract infections, upper respiratory tract infections and pneumonia, and they were comparable between gevokizumab and placebo.
"We have rapidly advanced our pyoderma gangrenosum clinical program since we launched our pilot study in June of 2013, and our End of Phase 2 meeting with the Food and Drug Administration will be taking place in March. We expect we will be able to announce our Phase 3 clinical program in this rare and serious indication during April," commented Paul Rubin, MD, Senior Vice President Research and Development and Chief Medical Officer of XOMA.
Celladon Corporation (Nasdaq: CLDN), a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, announced it has completed enrollment and randomized 250 patients in the phase 2b trial titled "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease," known as CUPID 2, which is evaluating the efficacy and safety of MYDICAR (AAV1/SERCA2a) in patients with NYHA class III/IV symptoms of systolic heart failure.
"The completion of enrollment in the CUPID 2 trial marks significant progress in the development of MYDICAR for patients with advanced heart failure and brings us one step closer to offering this important therapy to patients," said Krisztina Zsebo, Ph.D., President and Chief Executive Officer of Celladon Corporation. "We now look forward to April 2015, when we anticipate being able to report results from this important trial."
The CUPID 2 trial is a multinational, multicenter, double-blind, placebo-controlled, randomized trial of a single intracoronary infusion of high-dose MYDICAR (1 x 1013 DRP) versus placebo added to a maximal, optimized heart failure regimen. The primary objective is to determine the efficacy of MYDICAR in patients with ischemic or non-ischemic cardiomyopathy and advanced symptoms of heart failure by reducing the frequency and/or delaying heart failure-related hospitalizations compared to placebo-treated patients. Secondary objectives include assessment of terminal events, such as death, need for a ventricular assist device, or heart transplant. In addition, the safety of MYDICAR will be determined by assessing the incidence and severity of adverse events and changes in laboratory parameters.
"The fact that heart failure patients remain at significant risk for clinical deterioration over time, despite receiving maximal, optimized therapy with currently available drugs and devices, emphasizes the strong unmet need for new treatment options for these patients," said Barry Greenberg, M.D., FACC, Director, Advanced Heart Failure Treatment Program; Professor of Medicine, University of California, San Diego, and the Chairman of the Executive Clinical Steering Committee of the CUPID 2 trial. "Should the CUPID 2 trial show similar results to previous trials and subsequently result in approval of MYDICAR by regulatory authorities, I believe MYDICAR could play a significant role in improving the clinical course of heart failure patients."
Celladon has obtained a Special Protocol Assessment (SPA), whereby the U.S. Food and Drug Administration (FDA) has agreed to use time-to-multiple heart failure-related hospitalizations in the presence of terminal events (all-cause death, heart transplant, LVAD implantation) as the primary efficacy endpoint for a MYDICAR phase 3 pivotal trial. The CUPID 2 trial uses a similar clinical protocol with identical endpoints as agreed to in the SPA.
Celladon has received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the CUPID 2 trial. In November 2013, the EMA indicated that if MYDICAR demonstrates a substantial and highly significant treatment effect in the advanced heart failure population, and no untoward effects attributable to MYDICAR are observed, a safety database of approximately 205-230 subjects may be sufficient for a safety assessment to allow for acceptance of a Marketing Authorization Application for MYDICAR for the treatment of systolic heart failure. Celladon therefore believes that, if the above conditions are met, a phase 3 trial may not be required for marketing approval in Europe.
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