TIDMALK TIDMB 
 
 
   -- Small-scale Phase III trial replaces larger trial in agreement with 
      China's regulators and reduces development costs and time to market by 
      several years 
 
   -- First Chinese patients have been recruited and randomised following 
      exposure to house dust mite (HDM) allergens in a controlled environment 
 
   -- China is potentially the world's largest market for HDM allergy, with 
      more than 75 million people affected and just 300,000 receiving AIT 
 
   -- ALK's HDM SLIT-tablet would represent a major innovation on the market 
      and could launch as early as 2023 
 
 
   ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) has initiated a new Phase III 
clinical trial which is expected to significantly reduce development 
costs and time to market in China for its sublingual allergy 
immunotherapy (SLIT) tablet against house dust mite (HDM) allergy. 
 
   Subject to satisfactory results and a subsequent regulatory approval, it 
could allow ALK to target a product launch in China as early as 2023, 
thereby gaining access for its HDM tablet to a sizeable new market with 
significant unmet medical need. ALK currently serves the market with its 
own organisation with a range of diagnostic and SCIT products (also 
known as allergy shots). 
 
   Professor Luo Zhang, the trial's leading principal investigator in China 
said: "China has the potential to become the world's largest house dust 
mite allergy market, with more than 75 million HDM allergic people 
against a backdrop of 300,000 who currently receive AIT treatment. The 
existing market is served by a number of local suppliers, however, none 
of them offer a SLIT-tablet such as ALK's, which would represent a major 
innovation on the market." 
 
   The new trial involves approximately 200 patients and replaces a planned 
larger-scale Phase III field trial in allergic rhinitis patients in 
China. Trial participants are currently being recruited in China and 
will receive treatment there over a 24-week period. Prior to, and after, 
the 24 weeks of treatment, trial participants will travel to Vienna, 
Austria, where they will be exposed to house dust mite allergens in a 
controlled environment so that an assessment of treatment effect can 
take place. This will be done by comparing the pre-treatment baseline 
and post-treatment responses to their allergic symptoms. 
 
   The replacement of the large-scale Phase III trial with this shorter 
trial -- known as an 'environmental exposure chamber trial' due to the 
specially designed room, or chamber, where participants are exposed to 
the house-dust mite allergens -- is expected to reduce the time to 
market for the HDM tablet in China by several years. 
 
   ALK's Executive Vice President of Research and Development, Henrik 
Jacobi, said: "This innovative solution to a requirement from China's 
regulators is a testament to the creative efforts of our dedicated and 
highly professional clinical and regulatory affairs team, as well as the 
engagement and flexibility of the responsible authorities in China. Our 
substantial experience with the tablet portfolio, including 16 clinical 
house dust mite trials involving more than 4,000 patients, gives both 
parties every confidence that this new trial will provide sufficient 
additional data for a regulatory filing much sooner than originally 
planned." 
 
   The new trial is a randomised, parallel-group, double-blind, 
placebo-controlled Phase III trial involving approximately 200 subjects 
with HDM-induced allergic rhinitis. Subjects will be randomised into two 
groups of equal size, one of which will receive treatment with ALK's HDM 
tablet, while the other receives placebo. 
 
   ALK's HDM tablet was first launched in 2015 and is currently available 
in Europe, the USA and Canada, Japan, as well as several International 
markets where it is sold under the brand names ODACTRA(R) (USA), 
MITICURE(TM) (Japan), and ACARIZAX(R) (elsewhere). It is currently sold 
in a total of 19 countries with indications covering both allergic 
rhinitis and allergic asthma, and for use in children, adolescents and 
adults. The specific details of each approval vary according to country. 
Following the analysis and reporting of results from the new trial, ALK 
expects to file for regulatory approval of the HDM tablet in China soon 
afterwards. 
 
   ALK-Abelló A/S 
 
   For further information please contact: 
 
   Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 
2525 
 
   Media: Jeppe Ilkjær, mobile +45 3050 2014 
 
   About ALK 
 
   ALK is a global specialty pharmaceutical company focused on allergy and 
allergic asthma. It markets allergy immunotherapy treatments and other 
products and services for people with allergy and allergy doctors. 
Headquartered in Hørsholm, Denmark, ALK employs around 2,400 people 
worldwide and is listed on Nasdaq Copenhagen. Find more information at 
https://www.globenewswire.com/Tracker?data=67OiG8h29Sdg8__qrJkZUeaSujkn8bgA9mPeCsAAl__az6rRcm4ZmZeHGMxB1g6o-Ul65Vyf0XD4QCC0eqdZ47YwW_vo1TRlplJbhh6vimLI0GVLKWf6xgwMJIFme3m1OBVoMAczfTSyPDNw_FA7ftmgbLFRsqdGMtePP_xMSl0q5siMuLsYDFR1CptMy6dYNu5vglvjfzMH4lBUUsWDoB9cBf4RKhL678pZ6u7rO1M= 
www.alk.net 
 
   Attachment 
 
 
   -- ALK_PressRelease_ChamberStudyChina13Jan20 
      https://ml-eu.globenewswire.com/Resource/Download/0da9bbb3-76a9-4630-987e-10c3c35c420d 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

January 13, 2020 03:30 ET (08:30 GMT)