ASIT Biotech

33 articles about ASIT Biotech

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  Allergy Immunotherapy: Relief that is Nothing to Sneeze at

  2/27/2020

  *Achoo* Muddling through a stuffy, runny nose and itchy, watery eyes? You aren’t alone -  over 17.6 million American adults (about 7.5%) experience allergic rhinitis (also called hay fever or seasonal allergies). Many different substances (called allergens) can trigger allergic rhinitis, such as ...

• ASIT biotech Mode of Action Study of gp-ASIT+™ for Grass Pollen Allergy Published in The Journal of Allergy and Clinical Immunology (JACI)¹

  10/17/2019

  Data show how gp-ASIT+™, administered in a pre-seasonal 3-week treatment, is able to rapidly modulate the cellular response and induce production of blocking antibodies. This effect led to a significant reduction in the combined clinical symptom and medication score during the following pollen season.

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  Clinical Catch-Up: September 2-8

  9/9/2019

  Last week was a busy week for clinical trial results. Here’s a look at some of the top stories and reporting.

• ASIT biotech: Publishes the Documents Relating to the Extraordinary General Shareholders’ Meeting on 28 June 2019

  5/29/2019

  Upon approval by the shareholders, ASIT biotech expects to raise between €9M and €12M of convertible notes to finance its focused development

• ASIT biotech announces the achievement of new clinical and corporate development milestones

  5/2/2019

  The treatment phase of the confirmatory phase III clinical study with gp-ASIT+™ in grass pollen rhinitis is now completed for all patients, in time before the grass pollen season, with no major safety concerns. DSMB recommends continuing the study without modification.

• ASIT biotech’s Scientific Advisory Boards (SAB) provide positive recommendations on the clinical development of gp-ASIT+™

  3/29/2019

  The SAB, composed of international experts in the field of allergy immunotherapy, acknowledged the clinical benefits of gp-ASIT+™ and confirmed the interest of a follow-up study to enhance the future market positioning and differentiation of the compound.

• ASIT biotech reveals the mode of action of its lead immunotherapy product for Allergic Rhinitis, gp-ASIT+™, in The Journal of Allergy and Clinical Immunology (JACI)

  3/5/2019

  Data show how gp-ASIT+™, administered in a pre-seasonal 3-week treatment, is able to rapidly modulate pro-allergic cellular response and induce production of blocking antibodies. This effect led to a significant reduction in the combined clinical symptom and medication score during the following pollen season.

• ASIT biotech: 2019 Financial Calendar

  2/19/2019

  ASIT biotech, a Belgian biopharmaceutical company specialized in the research and development of innovative allergy immunotherapy products, announces its preliminary financial calendar for 2019.

• First patient treated with gp-ASIT+™ within the framework of the confirmatory Phase III study in grass pollen rhinitis

  1/31/2019

  The first treatment in this final study prior to the application for marketing authorization for the gp-ASIT+™ product candidate on the German market was undertaken on schedule at the Memmingen medical center in Germany

• Ongoing restructuring of ASIT biotech organization to maximize the success of gp-ASIT+™ in grass pollen rhinitis

  1/16/2019

  Reflecting the shareholders’ decisions, Michel Baijot is now leading the company as new CEO towards its reassessed strategic goals for 2019 and onwards

• ASIT biotech reaches another key milestone by finalizing the industrialization process for the manufacture of clinical batches of its hdm-ASIT+™ product candidate for house dust mite allergy

  12/17/2018

  This crucial step has allowed the Company to launch the final preclinica development required by the authorities ahead of a clinical trial

• Kepler Cheuvreux publishes an initiation of coverage report on ASIT biotech

  11/28/2018

  ASIT biotech today announces the publication of a report by Kepler Cheuvreux, a leading independent European financial services company specialized in research, execution and advisory services.

• ASIT biotech has installed and qualified a pilot unit to produce clinical batches for the Phase I/II studies in house dust mite and peanut allergies expected to start in H2 2019

  11/26/2018

  The active pharmaceutical ingredients (API) will be produced according to GMP requirements in a clean room rented from Accessia Pharma, a provider of high-quality pharmaceutical infrastructures 

• ASIT biotech launches its confirmatory Phase III clinical study with gp-ASIT+™ in grass pollen rhinitis prevention following the investigator meeting hosted in Prague (Czech Republic) on November 16-17, 2018

  11/19/2018

  Clinical trial authorizations received in all 6 participating countries

• ASIT Biotech 2017 Annual Results: Ongoing ASIT+ Products Development in Respiratory and Food Allergies

  2/12/2018

  ASIT Biotech today announces its annual results for the year 2017, prepared in accordance with the IFRS standards adopted by the European Union, as well as its recent clinical developments and 2018 outlook.

• ASIT Biotech Successfully Completes the First Tranche if its Capital Increase and Raises €9.4 Million

  1/26/2018

  A second subscription phase is currently taking place, and the Company has every hope it will obtain a swift subscription of the remaining €2 million of shares that can still be subscribed to on the basis of the approval granted by the Shareholders Meeting on 7 December.

• ASIT Biotech is Publishing a New Article on the Clinical Result of gp-ASIT+T in the Prestigious Science Journal ALLERGY

  1/11/2018

  ALLERGY is the official journal of the European Academy of Allergy and Clinical Immunology (EAACI).

• ASIT Biotech Reviews the Efficacy Results of gp-ASIT+

  12/15/2017

  The results presented to the EAACI show that over the course of the whole pollen season, gp-ASIT+ resulted in an average reduction in the combined score of 17.9% for the entire study population, close to the threshold of 20% required by the registration authorities.

• ASIT biotech Shareholders Meeting Has Approved the Structure of the Next Financing Round

  12/8/2017

  The first warrant will expire on June 30, 2018, and the second on December 31, 2019.

• ASIT Biotech Significantly Moves Forward in the Preparation of the Clinical Development Plan of gp-ASIT+ in the U.S.

  12/6/2017

  ASIT biotech has received positive feedback from the FDA on the preparation of the clinical development plan for gp-ASIT+ in the U.S., with only a few comments and the request for some clarification on the Master File.