|KaloBios Reports Phase 2 Study of KB003 Failed to Meet Primary Endpoint; Omeros Reports Positive Results from OMS824|
|By Staff and Wire Reports|
|Wednesday, 29 January 2014 20:20|
KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) announced the completion of the randomized, double-blind placebo-controlled Phase 2 study of KB003, its anti-GM-CSF monoclonal antibody (mAb), in patients with severe asthma. While the study showed that KB003 was generally safe and well tolerated, it did not meet its primary clinical endpoint of improvement in FEV1 (a measurement of pulmonary function) compared to placebo in the overall study population.
The company also evaluated improvement in FEV1 compared to placebo in a number of pre-specified subgroup analyses. Of those subgroups, eosinophilic patients (Baseline Blood Eosinophils ≥0.3 GI/L) and patients demonstrating high reversibility at baseline (>20%) showed a statistically significant improvement compared to placebo. Other subgroups such as atopic or non-atopic patients did not demonstrate a statistically significant improvement in FEV1 from baseline as compared to placebo. In the key secondary endpoints evaluated, there was no meaningful reduction in exacerbations observed in patients receiving KB003 in the overall study population or in any material subgroup as compared to those receiving placebo, and there was no statistically significant improvement in asthma control questionnaire (ACQ) scores in the overall patient population.
"The results of this study replicate the effects seen in our earlier Phase 1/2 study in eosinophilic and highly reversible patients. Unfortunately the drug effect did not include improvement in exacerbations and ACQ, nor was the FEV1 improvement seen in the broader patient population evaluated in this study," said Nestor A. Molfino, MD, MSc., KaloBios' Chief Medical Officer. "The KaloBios team is working to continue to analyze further the results of the study, and we plan to meet with thought leaders to better understand the outcomes in the various subgroups of the patient population included in the study. We expect to submit the full results to a scientific meeting or journal for future publication."
"We are obviously disappointed in this outcome given the unmet need for additional treatments for severe asthma," said David Pritchard, KaloBios' Chief Executive Officer. "Based on the initial data evaluation of this Phase 2 study, we are discontinuing clinical development of KB003 in severe asthma. Instead we will refocus our resources and efforts on advancing our other products in the clinic, especially KB001-A where we continue to enroll patients in our Phase 2 study evaluating treatment of cystic fibrosis patients with Pseudomonas aeruginosa (Pa) lung infections, and on KB004, our oncology program where we are commencing enrollment of the Phase 2 expansion trial evaluating patients with acute myeloid leukemia and myelodysplastic syndrome."
Conference Call with Management Management will host a teleconference and webcast to provide an overview of the trial results later today , January 29, 2014, at 4:30PM Eastern Time (1:30PM Pacific Time).
Interested parties can listen to the live teleconference by dialing (800) 514-4861 from the U.S. and Canada or +1 (484) 756-4333 for international callers. Individuals may access the live audio webcast by visiting the event URL at: http://ir.kalobios.com/events.cfm. A replay of the webcast will be available on the Company's website for 30 days following the live event.
KB003 Trial Design The Phase 2 clinical trial of KB003 in inadequately controlled severe asthma patients was a randomized, double-blind, placebo controlled study evaluating 160 patients randomized one to one between treatment with current standard of care plus either KB003 or placebo. Eligible patients were identified as severe asthma patients having had at least two exacerbations in the preceding 24 months. In addition, in order to participate in the study, eligible patients were required to be diagnosed as reversible at the time of enrollment, defined as patients whose FEV1 improved by 12% or more after receiving treatment via a bronchodilator. Patients enrolled in the 24 week study received, in addition to current standard of care, either placebo or a 400mg dose of KB003 every four weeks via intravenous administration, with one additional dose at week 2. The primary endpoint of the study was the change in FEV1 from baseline for patients in the KB003 arm as compared to those in the placebo arm. The study was powered at 80% to detect a 6.7% improvement in FEV1 when compared to placebo. FEV1 is a measurement of pulmonary function.
Omeros Corporation (NASDAQ: OMER) announced positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, in which the drug was well tolerated and demonstrated comparable systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with schizophrenia. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.
In this Phase 2a randomized, double-blind, placebo-controlled trial, OMS824 was administered at two dose levels for two weeks to psychiatrically stable patients whose antipsychotic medications were temporarily discontinued or who continued their usual antipsychotic regimen. The trial enrolled 33 patients, and the results showed that OMS824 was well tolerated, with mild or moderate adverse events that were self-limited and resolved during the treatment period. The tolerability and pharmacokinetics of OMS824 were not affected by concomitant antipsychotic medications, allowing the drug to be developed as both a monotherapy and as adjunctive therapy in combination with currently approved antipsychotics. The plasma concentrations of OMS824 in the high-dose cohort were similar to levels that corresponded to greater than 60 percent target occupancy of PDE10 in a Phase 1 positron emission tomography (PET) trial. Given the small sample size, efficacy conclusions cannot be drawn but the data support continued development in schizophrenia and other neuropsychiatric conditions.
The positive results from this Phase 2a trial suggest that dose adjustment will not be necessary when OMS824 is administered in combination with standard antipsychotic medications. Future Phase 2 and Phase 3 clinical trials in Omeros' schizophrenia program may evaluate OMS824 both as a single agent and as adjunctive treatment for cognitive impairment, acute exacerbation of symptoms, and/or inadequate response to antipsychotic medications.
"PDE10 is a novel target for the treatment of schizophrenia and other neuropsychiatric disorders with the potential to address limitations of current therapy," stated Michael Davidson, M.D., Professor in the Department of Psychiatry, Sackler School of Medicine, Tel Aviv University, Israel. "Inhibition of PDE10, which is a novel mechanism of action, may be able to treat not only the positive symptoms in schizophrenia but also the negative symptoms and cognitive impairment. The OMS824 data are the most promising of any PDE10 inhibitor, and I am eager to review additional clinical data for Omeros' drug product."
"We are excited by these positive clinical results," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Based on the favorable tolerability and pharmacokinetics of OMS824, we are considering evaluating additional higher dose levels in patients with schizophrenia. The data from the current trial open the door to developing OMS824 as monotherapy or in conjunction with other antipsychotics for schizophrenia and a wide range of other psychiatric and neurologic disorders."
In addition to its schizophrenia program, Omeros expects to begin enrollment this quarter in a Phase 2 clinical trial evaluating OMS824 in patients with Huntington's disease.
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