14 sep: Salg af de danske vindaktiviteter
14 sep: Victoria Properties A/S – fortegningsemission, optagelse til hand..
14-09-2017 13:15:00

Successful Phase III trial for ALK’s tree allergy SLIT-tablet

Relateret indhold
12 jun - 
C25-selskaber/Jyske: Dropper dækning af flere selskaber
08 jun - 
ALK-Abelló/SHB: Kan slippe for den værste tilskudsskræk..
06 jun - 
NKT presset af skeptiske investorer: Nu er hver syvende..
Relateret debat
12 jun - 
Naee... købte i 720 for nogle måneder siden - 50 pct.!!..
12 jun - 
Nahr - short squezze vil snarere give en endnu hurtigre..
12 jun - 
Aktien er shortet, nok derfor ?

 

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced the successful outcome of a pivotal Phase III clinical trial of its tree allergy sublingual immunotherapy (SLIT) tablet, with the trial meeting its primary efficacy endpoint. The tree SLIT-tablet is important to ALK's efforts to develop a full tablet portfolio for people suffering from the most common respiratory allergies. ALK is currently the only company that has completed Phase III clinical development with a tree SLIT-tablet.

 

The primary endpoint of the trial was the daily total combined score, which is the sum of the allergic symptom score and the use of symptom-relieving medication, measured during the birch pollen season. Treatment with the tree SLIT-tablet reduced the total combined score (primary endpoint) by 39.6% compared to placebo. The results were highly statistically significant (p < 0.0001). The efficacy was similar when analysing data for the entire tree pollen season (i.e. including the alder and hazel pollen seasons). The trial also showed that the treatment was well-tolerated by patients, with no new or unexpected adverse events reported compared to previous clinical trials with SLIT-tablets.

 

Henrik Jacobi, ALK’s Executive Vice President, Research and Development, says: "We are extremely pleased to see such a clear and clinically meaningful treatment effect of the tree allergy immunotherapy tablet. In fact, the clinical effect seen in this trial was among the most significant that we have ever seen in field studies of allergy immunotherapy, which means that we have developed a unique compound.”

 

He continues: “With SLIT-tablets for house dust mite, grass, ragweed and Japanese cedar allergies already filed or marketed, these trial results represent an important step forward for ALK in completing its tablet portfolio. With these five tablets, we will be able to effectively cover more than 80% of global respiratory allergies."

 

ALK initiated the Phase III clinical trial in 2016 to evaluate the efficacy and safety of the tree SLIT-tablet compared with placebo in adult and adolescent patients with birch pollen allergic rhinitis and/or conjunctivitis. The trial was a randomised, placebo-controlled, double-blind, multi-centre trial involving 634 patients aged 12-65 years in eight European countries. A preceding Phase II trial in an environmental exposure chamber showed that the tablet significantly reduced patients’ symptoms in response to both birch and oak pollen compared with placebo.

 

Allergic rhinitis (with or without conjunctivitis) represents a global health problem affecting 10 to 25% of the population. The prevalence in the general population in Europe and North America is ~20%. In Northern and Central Europe, USA and Canada, respiratory allergies are commonly caused by allergens from the birch homologous group of trees, which also includes alder, beech, hazel and oak. ALK estimates that around 15 million Europeans have tree allergies of which ~10% are believed to have symptoms that are not well controlled by conventional symptom-relieving medications. For some of these people with uncontrolled allergies to tree pollen, ALK’s tablet may become a relevant treatment option.   

 

ALK expects to submit a European and possibly also a Canadian registration application for the tree SLIT-tablet in 2018.

 

ALK-Abelló A/S

 

For further information please contact:

Henrik Jacobi, Executive Vice President, Research and Development, tel. +45 4574 7576

Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525

Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014

 

About ALK

ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy – a treatment of the underlying cause of allergy. The company has approximately 2,300 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen.

Find more information at www.alk.net.

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/62be4ea4-c1f2-4989-8cab-af24681d3566

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
Ingen indlæg

Vind: Tyrkiet åbner op bud på 1,2 GW havvind

22-06-2018 12:08:41
Tyrkiet har lanceret landets første budrunde på havvindenergi og har allokeret en kapacitet på 1,2 gigawatt til formålet. Myndighederne har fastlagt et loft for budprisen på 80 dollar per megawatt-time, og interesserede selskaber og konsortier skal senest 23. oktober indlevere deres bud. Støtten vil blive givet i form af en elsalgsaftale for de første 50 terawatt-timer produceret energi, skriver R..

Unibrew/Danske: Kursmålet løftes til 525 kr.

22-06-2018 10:45:53
Royal Unibrews opjustering torsdag eftermiddag har fået Danske Bank til at løfte sit kursmål for bryggeriaktien til 520 kr. fra 475 kr. Anbefalingen er uændret "hold", viser data fra Bloomberg News.Unibrews nye prognose lyder på en omsætning mellem 6,8 og 7 mia. kr., et primært driftsresultat (EBITDA) på 1550 til 1625 mio. kr. og et driftsresultat efter af- og nedskrivninger på 1190 til 1265 mio. ..

Aktier/tendens: Unibrew kan ryge op i forventet rolig markedsåbning

22-06-2018 08:07:28
En opjustering fra Royal Unibrew bliver et af fokuspunkterne i fredagens tidlige danske aktiehandel, som generelt ser ud til at ville være præget af mindre bevægelser. Efter torsdagens danske børslukning, hvor det danske C25-indeks sluttede 0,2 pct. lavere i indeks 1119,14, var der ganske vist et lille fald i de amerikanske aktier på Wall Street. Men fredag morgen er der marginale plusser i handle..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge

Relaterede aktiekurser

ALK-Abelló B A/S 1.068,00 -0,2% Fald i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2018  Disclaimer  |  Cookie- og privatlivspolitik  |  Persondatapolitik
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
24. juni 2018 01:14:54
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20180619.1 - EUROWEB1 - 2018-06-24 01:14:54 - 2018-06-24 01:14:54 - 1 - Website: OKAY