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The primary endpoint was not met in a Phase II/III emphysema treatment trial.
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After a long and tense wait for its investors, on Friday Kamada Ltd.(TASE: KMDA) announced preliminary top-line results from the Phase II/III pivotal clinical trial in Europe and Canada of its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD or inherited emphysema). The investors were evidently disappointed by the announcement, for in its wake, Kamada’s share price plunged by over 34% on Nasdaq. The share price is down by a similar amount in this morning’s trading on the Tel Aviv Stock Exchange.
The company said that the endpoints selected for this trial were based on scientific advice from the European Medicines Agency (EMA) and include those deemed to be clinically meaningful, such as frequency, time to first, duration and severity of exacerbation events, among others. “A preliminary analysis of the results indicates clinically meaningful signs for inhaled AAT efficacy as well as additional positive signs in specific study populations. In a very important secondary endpoint, frequency of severe exacerbation was approximately 50% lower in the AAT group versus placebo. With regards to the primary endpoint of “time to first moderate or severe exacerbation, ” early data do not show differences between the two treatment groups. The company continues to analyze the data in accordance with the statistical plan and intends to release a more profound set of results in third quarter of 2014, ” the announcement said.
“We received preliminary trial results, and today are reporting partial and early stage data regarding the primary endpoint and certain key secondary endpoints. We have detected clinically meaningful signs for inhaled AAT efficacy as well as additional positive signs in specific study populations, and are examining these data further to better understand the results and to assure the information is valid and correlates with additional clinical parameters, ” said Pnina Strauss, Vice President of Clinical Development and Intellectual Property of Kamada. “Severe exacerbations involve hospitalizations and deterioration of respiratory symptoms including breathlessness, increased sputum volume, change in sputum color and/or purulence. A decrease in severe exacerbations is a significant benefit to patients and will lower the overall cost of healthcare, which includes usage of drugs and hospitalization, among others.
“We believe the existing data support a regulatory filing in Europe, and will continue as planned to meet with the EMA according to the centralized procedure for licensure during the fourth quarter of this year, ” added Ms. Strauss.
In August 2012 Kamada signed an exclusive agreement for the distribution of its inhaled AAT for the treatment of AATD in Europe and with Chiesi Farmaceutici S.p.A, a fully integrated European pharmaceutical company focused on respiratory disease and special care products. Under the agreement, Kamada is eligible to receive milestone payments of up to $60 million, subject to achievement of certain regulatory and sales targets.
Kamada recently initiated a US Phase II clinical trial with its inhaled AAT for AATD, and expects that the data from the European trial together with the data from the US trial will support licensure application in the US and additional territories.
Published by Globes [online], Israel business news – www.globes-online.com
