- Clinical trial authorizations received in all 6 participating countries
- Investigators from 82 participating centers have been trained and patient enrollment is expected to start as early as January 2019
- Based on the learnings from the first Phase III study, major improvements have been successfully implemented to maximize the probability of success of this confirmatory Phase III study
- Study results expected in December 2019
Regulatory News:
ASIT biotech (Paris:ASIT) (BSE:ASIT) (ASIT BE0974289218), a Belgian biopharmaceutical company specialized in the research and development of innovative allergy immunotherapy products, today announced that it hosted the investigator meeting in Prague (Czech Republic) on November 16-17, 2018 ahead of the launch of its confirmatory Phase III clinical study with gp-ASIT+ in grass pollen rhinitis prevention.
The investigator meeting was attended by 142 participants including the investigators team, the ASIT biotech clinical operations team, the team of the CRO (Contract Research Organization) that will coordinate the trial, ICON plc, and different vendors. The objectives of the meeting consisted mainly in establishing rules for effective communication, defining precisely each participant's role and responsibilities and communicating detailed information about the clinical study to ensure it is managed efficiently.
In order to overcome the challenges related to the clinical development in this indication such as overweighting of a center or a country, a lack of pollen or malfunctioning pollen traps, the selection of weakly allergic patients, and poor-quality medication use and symptom data due to poor reporting by patients, ASIT biotech has successfully implemented 9 major improvements following the first Phase III performed in this indication:
- The new Phase III study has been subcontracted to a single CRO, ICON plc, with leading experience in allergy studies.
- Oversight is executed internally by a well-staffed clinical operations team, including a Team Leader with 30 years' clinical development experience, a Chief Medical Officer with 30 years' clinical development experience and two Clinical Project Managers with 10 years' clinical development experience each.
- High pollen count and high-quality data recording history has been used to select the relevant clinical centers.
- To avoid recruitment issues and prevent a single center or country from being overweighted, 82 clinical centers across 6 countries (Germany, Belgium, France, the Czech Republic, Hungary and Poland) are involved in the current Phase III clinical study, and each center is limited to a maximum number of randomized patients.
- A medical history of moderate to severe pollen allergy over the last two years is required for each patient in order to randomize the most allergic ones.
- Patient recruitment at each clinical site is monitored online in line with a provisional schedule established using historical regional grass pollen data for the last 5 pollen seasons.
- Electronic rather than paper diaries are used to significantly improve patient commitment to better data recording and quality.
- Pollen count monitoring is centralized by the European Aeroallergen Network from the University of Vienna to guarantee the reliability of the pollen count data used for statistical analysis.
- The launch date is earlier than for the first Phase III study, allowing for a longer randomization and treatment period prior to the grass pollen season.
In total, 624 patients with grass pollen allergy are due to be enrolled in the study, compared to 554 in the initial phase III study. The first patient first visit is expected in January 2019 and the last patient last visit in September 2019, which should allow the Company to obtain the study results in December 2019.
The primary objective of the study is a 20% reduction in the combined clinical symptom and medication score (CSMS) in the treated group compared to placebo (i.e. an absolute score difference versus placebo of at least -0.30).
As discussed with the German health authority, Paul-Ehrlich-Institut (PEI), within the framework of a scientific advice session held in June 2017, in case of compelling new phase III results, PEI could allow ASIT biotech to file a Marketing Authorization Application (MAA) for Germany, with this marketing authorization then being extended to other European countries in line with international guidelines.
Thierry Legon, CEO of ASIT biotech, commented"I would like to congratulate our clinical team on this successful investigator meeting that marks the launch of our confirmatory Phase III study with gp-ASIT+ in grass pollen rhinitis prevention. The clinical teams across all 82 participating centers are now fully focused on the preparatory work for the recruitment of first patients, expected to begin in January 2019. Our objective is to treat all patients before the 2019 pollen season starts, so we can obtain the full data set by the end of 2019. I would also like to emphasize that our other allergy-immunotherapy programs, in food and house dust mite allergy, are progressing on schedule, with the first clinical trial authorization submission for pnt-ASIT+ in peanut allergy expected by the end of H1 2019. Thanks to this expanded pipeline, ASIT biotech's profile has never been so strong since its introduction on the stock market"
Pr Claus Bachert, Head of Clinics at the Oto-Rhino-Laryngology department of the University Hospital Ghent (Belgium) and Principal Investigator of the study, explained: "In the previous Phase III study, we were slightly below the threshold for registration, but the results obtained in our Clinical Center at the University Hospital Ghent on a subset of 32 patients (21 treated/11 placebo) pre-selected to study the mechanisms of action were really encouraging. One week after the end of the three-week treatment all the immunoregulatory mechanisms needed to control the allergic reaction were in place, leading to a symptom and symptomatic drug intake score reduction well above the threshold required by the study protocol. The improvements implemented for this new phase III trial make us confident that the study will proceed as smoothly as possible, and we are thrilled that patient recruitment will begin shortly."
Rémy von Frenckell, Head of Clinical Development of ASIT biotech, concluded: "After a 20-year career as Vice President Biostatics at UCB, I am proud to be taking over as Head of ASIT biotech's clinical operations team. In the last few months, we have assembled a very robust team, including Gilles Della Corte as Chief Medical Officer and Florence Lair and Sabine Pirotton as Clinical Project Managers. With their outstanding careers in clinical development, our team is perfectly placed to conduct this crucial clinical trial with gp-ASIT+."
Upcoming event
- Open Day for shareholders at ASIT biotech: November 26, 2018 (10:00 am 12:00 am) Rue des Chasseurs Ardennais 7, 4031 Angleur (Belgium) If you wish to participate, you can register by sending an e-mail to asitbiotech@newcap.eu with your contact information.
About ICON plc
ICON plc is a global provider of outsourced drug development and commercialisation solutions and services to pharmaceutical, biotechnology, medical device, and government and public health organisations. The company specializes in the strategic development, management and analysis of programs that support clinical development from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 93 locations in 37 countries and has approximately 13,675 employees.
Further information is available at https://www.iconplc.com
About gp-ASIT+
gp-ASIT+ product candidate for the treatment of grass pollen rhinitis consists of a mixture of natural allergen fragments obtained from a purified specific proteinic extract from Lolium perenne pollen. In contrast to the synthetized peptides, the natural peptides (70% of the fragments ranging from 1,000 The administration schedule of the treatment is of short duration compared with currently commercialized treatments. This constitutes a major competitive advantage to improve the acceptance and the compliance of the patients. In addition, the administration schedule includes successive injections with half of the visit dose in both arms, an innovative solution that enables the delivery of the total dose necessary for the therapeutic effect in a faster and safer way. Finally, the product candidate is formulated without adjuvant, which increases the long-term safety of the product by decreasing the local and general reactogenicity as well as the frequency of the adverse events, which represents a further advantage in markets less permissive to adjuvanted formulations (e.g. US). Except for the clinical efficacy during natural grass pollen exposure that was investigated in the first phase III clinical study with gp-ASIT+, all the above-mentioned characteristics have been demonstrated in the already conducted clinical studies. The phase III clinical study of gp-ASIT+ was conducted in 67 clinical centers in Belgium, the Czech Republic, France, Germany, Italy and Spain, and involved 554 randomized patients suffering from grass pollen rhinoconjunctivitis. About ASIT biotech ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+ technology platform, ASIT biotech is currently the only developer of allergy immunotherapy (AIT) product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech's product pipeline contains three novel ASIT+ product candidates targeting respiratory allergies with the highest prevalence (i.e. grass pollen: gp-ASIT+ and house dust mite: hdm-ASIT+), and food allergies (peanut allergy: pnt-ASIT+) that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+ platform is flexible and would be applicable across a range of allergies. ASIT biotech has a headcount of 26 staff members, at its headquarters in Brussels and a laboratory in Liège, Belgium. Further information can be found at www.asitbiotech.com Forward-looking statements All statements in this announcement that do not relate to historical facts and events are "forward-looking statements". In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes," "estimates," "anticipates," "expects," "intends," "may," "will," "plans," "continue," "ongoing," "potential," "predict," "project," "target," "seek" or "should" or, in each case, their negative or other variations or comparable terminology or by discussions of strategies, plans, objectives, targets, goals, future events or intentions. Forward-looking statements include statements regarding the Company's intentions, beliefs or current expectations. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance. Given these risks and uncertainties, you should not rely on forward-looking statements as a prediction of actual results. Any forward-looking statements are made only as of the date of this announcement and, without prejudice to the Company's obligations under applicable law in relation to disclosure and ongoing information, the Company does not intend, and does not assume any obligation, to update the forward-looking statements set forth in this announcement. Legal notice The Company is responsible for the information contained in this press release. This announcement does not constitute, or form part of, an offer or invitation to sell or issue, or any solicitation of an offer to purchase or subscribe for shares of ASIT biotech SA (the "Company" and the "Shares"). Any purchase of, subscription for or application for, shares to be issued in connection with the intended offering should only be made on the basis of information contained in the prospectus and any supplements thereto, as the case may be. This announcement does not constitute a prospectus and the information contained herein is for information purposes only and does not purport to be full or complete. Investors should not subscribe for any Shares except on the basis of the information contained in the prospectus that the Company expects to publish after its approval by the Belgian Financial Services and Markets Authority, and which can then be obtained at the Company's registered office and on www.asitbiotech.com This announcement is not for distribution, directly or indirectly, in or into the United States or to any U.S. person within the meaning of the U.S. Securities Act of 1933, as amended (the "Securities Act"). The Shares have not been and will not be registered under the Securities Act and may not be offered or sold in the United States, except pursuant to an exemption from the registration requirements of the Securities Act. The Company has not registered, and does not intend to register, any portion of the intended offering of Shares in the United States, and does not intend to conduct a public offering of Shares in the United States. This announcement and the information contained herein are not for publication, distribution or release in or into the United States, Australia, Canada, Japan or any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction. View source version on businesswire.com: https://www.businesswire.com/news/home/20181118005038/en/ Contacts: Company
Thierry Legon, CEO
ASIT biotech
Tel.: +32 2 264 03 90
investors@asitbiotech.com
Media and Investor Relations France
NewCap
Dusan Oresansky Pierre Laurent
Tel.: +33 1 44 71 94 92
asitbiotech@newcap.eu
Media Relations Belgium
Laure-Eve Monfort
Tel.: +32 2 290 90 93
monfort@comfi.be