Kamada Ltd. (Nasdaq: KMDA); TASE: KMDA) today confirmed the results of its initial trial published three and a half months ago. At that time, the company reported disappointing results in its Phase II/III trial of its inhaled Alpha-1 antitrypsin (AAT) product for treatment of hereditary emphysema (a disease that attacks the lungs)
The company’s share price is down almost 20% on Nasdaq.
Following a full analysis of the trial data, the company confirmed that the initial measure in the “time to the first moderate or severe exacerbation event” showed no significant statistical difference between the inhaled AAT group and the placebo group in the population of patients in the trial, as reported in May of this year. The company also reported that no statistically significant differences were found in the secondary measures in the trial between the inhaled AAT group and the placebo group in the ITT population.
At the same time, Kamada stated, “Despite not meeting the primary or secondary endpoints for the ITT population, lung function parameters, including Forced Expiratory Volume in One Second (FEV1) % of Slow Vital Capacity (SVC), FEV1 % predicted, FEV1 (liters) and Diffusing capacity (DLCO), which were collected to support safety endpoints, showed concordance of a potential treatment effect in the reduction of the inflammatory injury to the lung that is known to be associated with a reduced loss of respiratory function. These effects were most apparent in the frequently exacerbating patients (the ‘Most Frequent Exacerbators’), who represented more than 70% of those enrolled in the study.”
“We strongly believe the clinically meaningful differences seen in lung function parameters are therapeutically relevant, particularly with regard to the Most Frequent Exacerbators, who have the greatest need for effective new therapies and comprise a major portion of this orphan patient population, ” noted Kamada cofounder and CEO David Tsur.
“Based on orphan designation of the drug, prior discussions held with the regulator, the strength of these data and the persistent unmet need in this orphan indication, we will advance our discussions with the European Medicines Agency with the intent to submit for conditional approval in order to bring our inhaled AAT to patients with AATD in Europe, and will initiate discussion with the FDA to determine a U.S. path for registration, ” Tsur added.
Kamada, which markets drugs primarily in the pulmonary field, published poor financial results two weeks ago for the second quarter, with a fall in revenue and profit, combined with a steep rise in various expense items. Revenue was down slightly to $15.8 million, with the company reporting a gross loss of $66, 000, compared with a $7.4 million gross profit in the corresponding quarter last year. The company posted an $8.3 million quarterly net loss, compared with an $890, 000 net profit in the corresponding quarter in 2013.
Published by Globes [online], Israel business news – www.globes-online.com