|Adamis Announces Positive Results For Its Dry Powder Inhaler Product; Biota Commences Dosing in Vapendavir SPIRITUS Phase 2b Trial|
|By Mary Davila|
|Tuesday, 03 March 2015 19:11|
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced the results of its pharmacokinetic (PK) study for its dry powder inhaler product, APC-5000. The study was a Phase I PK study comparing the bioavailability of Adamis' APC-5000 Dry Powder Inhaler (DPI) to GlaxoSmithKline's Advair® Diskus® DPI.
This PK study was designed as an open-label, randomized, single-dose, 4 period (2 sequence, 2 treatment, fully replicated) crossover relative bioavailability study comparing APC-5000 (Fluticasone Propionate (FP) 186 µg and Salmeterol Xinafoate (SX) 44.7 µg; 3 inhalations; total dose 558/134.1 μg FP/SX) and Advair® Diskus® 250/50 µg (3 inhalations; total dose 750/150 μg FP/SX). Sixteen healthy male and female subjects who met the study inclusion criteria were enrolled into the study. The study involved a screening period and four treatment periods separated by four days. After completion of screening procedures, subjects were randomized to receive two doses of each Test and Reference product in four treatment periods. All sixteen subjects completed the study.
APC-5000 utilizes the patented Taper DPI inhaler device which, in this case, has been developed to eliminate the need for complex powder treatments and additive substances such as lactose, i.e. there is no need for excipients. It was also developed to deliver a higher percentage of fine particles to the airways with better delivery efficiency, and by doing so, decrease the drug deposition in the throat and mouth. Because of this increased efficiency, less amount of drug is loaded into the device thereby reducing the amount of drug given to the patient while still maintaining the same theoretical therapeutic dose. The study results confirm that systemic exposure to the drugs FP and SX is reduced after treatment with APC-5000, as compared to Advair® Diskus®, thereby potentially increasing the overall safety of the product.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "Based on the study conclusions and the extent of PK similarities between APC-5000 and Advair®, we predict that our product (APC-5000), while using less drug, will still be as efficacious as Advair® for the treatment of asthma and chronic obstructive pulmonary disease (COPD). This hypothesis will be tested in a Phase III study comparing the efficacy of APC-5000 and Advair® for non-inferiority."
Biota Pharmaceuticals, Inc. (NASDAQ: BOTA) announced it has commenced dosing of patients in its Phase 2b SPIRITUS trial of vapendavir. The goal of the study is to enroll approximately 150 laboratory-confirmed human rhinovirus (HRV) infected patients with moderate-to-severe asthma from the United States and multiple European countries over the next 12 months and to report top-line data in mid-2016.
"There are no antivirals currently approved for the treatment of HRV infection, which is a major cause of disease exacerbation among patients with asthma and COPD. Therefore, the initiation of this important trial of vapendavir in moderate-to-severe asthmatics is truly exciting, and based on the positive outcome from the Phase 2 study in mild asthmatics, I am looking forward to the data from this trial next year," stated Dr. Jonathan Matz, allergist-immunologist and Principal Investigator of the SPIRITUS trial.
"The commencement of dosing in our SPIRITUS trial represents a significant achievement in our ongoing effort to further define the efficacy and safety profile of vapendavir in patient populations with respiratory disease, whose disease control is at risk due to viral respiratory infection," commented Anna Novotney-Barry, Vice President of Clinical Development at Biota.
The primary endpoint of this multi-center, randomized, double-blind, placebo-controlled dose-ranging study is the change from baseline to study day 14 measured by an asthma control questionnaire (ACQ)-6 total score. The secondary endpoints are focused on safety and tolerability, lung function assessments such as forced expiratory volume in one second (FEV1), incidence of asthma exacerbations, assessments of the severity and duration of cold symptoms measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) and virological assessments such as changes in viral load.
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