|Vanda Announces Tradipitant Phase II Proof of Concept Study Results for Chronic Pruritus; Aerpio Announces Publication of Positive Results of Phase 1b/2a of AKB-9778|
|By William Kent|
|Wednesday, 04 March 2015 20:42|
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced top-line results of the Phase II proof of concept clinical study investigating the safety and efficacy of tradipitant as a monotherapy in the treatment of chronic pruritus in patients with atopic dermatitis. Despite a highly significant and clinically meaningful improvement from baseline by tradipitant (40.5mm improvement from baseline, p<0.0001) as measured on a 100mm unit Visual Analog Scale (VAS) for itch, a very high placebo effect (36.5 mm improvement from baseline, p<0.0001) on the change from baseline led to no statistical difference from placebo. However, subsequent analysis of population PK samples across all patients in the study revealed significant and clinically meaningful responses across multiple outcomes evaluated in individuals with higher levels of tradipitant exposure at the time of their pruritus assessments.
"The results of this exploratory study are encouraging and promising; a target-specific therapy using an NK-1 receptor antagonist in severe atopic dermatitis pruritus is a novel concept and will help AD patients suffering from the symptom worldwide," said Dr. Sonja Staender, Department of Dermatology, and Head of the Interdisciplinary Competence Center Chronic Pruritus (KCP) of the University Hospital in Munster, Germany.
Tradipitant, formerly known as VLY-686, is a neurokinin 1 receptor antagonist under clinical investigation for the treatment of chronic pruritus in patients with atopic dermatitis. The pre-specified primary endpoint of the Phase II proof of concept clinical study was the change from baseline on the Visual Analog Scale (VAS) for itch. Due to high placebo effect, there was no significant difference from placebo on this pre-specified endpoint, however, Vanda believes this proof of concept study was informative, in that through subsequent analyses, it has discovered an exposure response relationship and further observed a significant and clinically meaningful response across several pruritus related outcomes evaluated in individuals with higher blood plasma levels of tradipitant. This is not unexpected given that all the assessments related to pruritus are significantly associated with the itch sensation the patient is experiencing at that time. Based on the data Vanda examined across the study, lower blood plasma levels of tradipitant may be below a threshold of efficacy to ameliorate the itch sensation in patients.
Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel therapeutics for vascular disorders with an emphasis on diseases of the eye, today announced publication of positive results from the company’s Phase 1b/2a clinical study of lead clinical candidate, AKB-9778, a Tie2 activator. AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leakage. The Phase 1b/2a study, named “TIME-1”, showed that AKB-9778, administered subcutaneously for 28 days as monotherapy in patients with DME, was well-tolerated and produced clinically meaningful reductions in retinal thickness, correlating with improved visual acuity. The TIME-1 clinical results have been published in an article titled, “Treatment of Diabetic Macular Edema with an Inhibitor of Vascular Endothelial-Protein Tyrosine Phosphatase That Activates Tie2,” DOI: http://www.aaojournal.org/article/S0161-6420(14)00901-4/fulltext, which is appearing in the March 2015 print edition of Ophthalmology, the journal of the American Academy of Ophthalmology.
A total of 24 patients with DME participated in the 28-day, open-label, dose-escalation Phase Ib/2a trial. Cohorts of six patients each were treated with 5 mg, 15 mg, 22.5 mg and 30 mg of AKB-9778 delivered subcutaneously BID for 28 days, and patients were observed for an additional 56 days. As previously reported, all dose levels of AKB-9778 were well-tolerated, with no serious adverse events observed. After one month of treatment at doses of 15 mg or greater, 7 out of 18 patients demonstrated a reduction in central subfield thickness (CST) in the study eye of greater than 50µm, and 13 out of 18 patients gained 5 or more letters of visual acuity in the study eye as measured by the best corrected visual acuity (BCVA) assessment.
“The publication in the AAO journal is the first to demonstrate that activating Tie2, an alternative pathway to currently available anti-VEGF agents, can have a meaningful impact on both reduction in retinal edema and improved visual outcomes,” said David S. Boyer, MD, Retina-Vitreous Associates Medical Group. “Importantly, the study showed a significant correlation between measures of BCVA and CST, providing further proof of concept for this promising therapeutic modality in patients.” Based on the clinical results of the Phase 1b/2a study, in February 2014 Aerpio announced the initiation of a randomized, double-masked Phase 2 trial, named “TIME-2,” evaluating AKB-9778 alone and in combination with ranibizumab (Lucentis®), for the treatment of DME.
“We are pleased with the progress of our AKB-9778 clinical program and that we have reached the milestone of completing enrollment on schedule in the TIME-2 study,” stated Joseph Gardner, Ph.D., President and CEO of Aerpio. “We believe that AKB-9778 has the potential to profoundly impact the treatment of diabetic eye disease, both as monotherapy, as well as an adjunct to existing treatments. Based on our current timelines, we anticipate reporting topline data from the TIME-2 study sometime in the second quarter of 2015.”
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