- The clinical trial investigates safety and tolerability of an accelerated up-dosing schedule
- Study compares three-injection and six-injection schedules in adults with house dust mite allergy
Leiden, the Netherlands / Düsseldorf, Germany, October 29, 2026—HAL Allergy has enrolled the first participant in a new clinical study investigating an accelerated up-dosing schedule for an investigational subcutaneous house dust mite allergen immunotherapy (PM50k). The preparation and accelerated schedule are not approved for routine clinical use. The study will assess safety and tolerability during the initial phase in which the dose is increased toward the maintenance dose.
Following completion of Phase III study PM/0059 and submission of its data to the Paul-Ehrlich-Institut as part of the marketing authorization application, HAL Allergy has initiated a further clinical study within its house dust mite development program. Under the study protocol, the accelerated schedule comprises three injections over two weeks, compared with six injections over five weeks in the conventional schedule previously evaluated in study PM/0059. The new study will assess the safety and tolerability of these schedules. Results are not yet available.
The Phase II study PM/0062 is a randomized, open-label trial conducted at 15 study sites in Germany and Poland, with planned enrollment of 120 adults aged 18 to 65 with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. Participants will be randomly assigned to either the accelerated or the conventional schedule. The study focuses on safety and tolerability during the up-dosing phase. Both groups receive the same investigational preparation.
“The enrollment of the first participant marks the start of a further clinical investigation in our house dust mite development program,” said Dr. Dr. Philip Böhme, CEO of HAL Allergy Group. “The study will generate data on the safety and tolerability of an accelerated up-dosing schedule compared with the conventional schedule. We thank the participants and study teams for their contribution and look forward to making the findings available to the scientific community.”
Completion of the study is planned for 2027.
About HAL Allergy
With more than 60 years of experience, HAL Allergy (NL) is a privately owned European specialty biopharmaceutical company dedicated to allergies and related diseases. Its activities are built on proprietary allergen extraction, advanced allergoid technology and GMP-certified manufacturing. On this basis, the company covers the full allergy care pathway—from diagnostics and specific immunotherapy to next-generation treatments.
Supported by continuous investment in research and development and a robust clinical pipeline, HAL Allergy aims to expand beyond allergy into adjacent disease areas, leveraging its expertise to improve the lives of a broad patient population. The company is present in eight countries with its subsidiaries. HAL Allergy is part of the Droege Group (Düsseldorf).
Note on the investigational product
The house dust mite preparation (PM50k) and the accelerated up-dosing schedule investigated in this study are investigational and are not approved in any country. Any decision on whether and how they may be authorized for use will be taken by the competent authorities following review of the relevant data. This information does not replace medical advice and does not constitute a recommendation for any specific treatment.
Media Contact
Heike Milan
HAL Allergie GmbH
Phone: +49 (0)211 97765 56
Email: hmilan@hal-allergy.com
HAL Allergy—Medical Information
Phone: +49 (0)211 97765 70
Email: medwiss@hal-allergy.com