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
Conference Call with Management
Management will host a teleconference and webcast to provide an overview of the trial results later today ,
Interested parties can listen to the live teleconference by dialing (800) 514-4861 from the U.S. and
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.
Currently, KaloBios has three drug development programs:
All of the company's antibodies were generated using its proprietary Humaneered® technology, a method that converts nonhuman antibodies (typically mouse) into recombinant antibodies that have a high binding affinity to their target and are designed for chronic therapeutic use. The company believes that antibodies produced using its Humaneered® technology offer important clinical and economic advantages over antibodies generated by other methods in terms of high binding affinity, high manufacturing yields, and minimal to no immunogenicity (inappropriate immune response) upon repeat administration in humans.
For more information on
Forward Looking Statements
This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and statements regarding the company's clinical development of KB001-A, KB003 and KB004. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the analysis of summary data from clinical studies, including but not limited to KB003-04, the potential, if any, for future development of KB003, the company's limited cash reserves and its ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that the company has initiated or plans to initiate; the company's dependence on
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company has no obligation, and expressly disclaims any obligation to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, visit http://www.kalobios.com.
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