Desentum reports positive findings for the First-in-Human clinical study of lead product candidate in birch pollen allergic adults
Today, Desentum announced positive First-in-Human clinical data of DM-101, its lead candidate for treatment of birch pollen allergy. DM-101 was found to be safe and well tolerated in a dose regimen of 5 ascending doses, and immunological marker results indicated a favourable immunological response.
“We are very happy to have completed the clinical study despite the challenges posed by the Covid-19 pandemic. The preclinical models available for testing allergen immunotherapy products are indicative at best, so the First-in-Human clinical study was an important milestone towards the clinical Proof-of-Concept. Although this was an early-phase study, the results are very encouraging and provide valuable information for planning the next study”, says Pekka Mattila, CEO of Desentum.
The randomised, double-blinded, placebo-controlled, dose escalation study was designed to evaluate the safety and tolerability of subcutaneous immunotherapy with DM-101 in birch pollen allergic adults. Immunological markers such as allergen-specific IgE and IgG were also analysed. For the study, 27 adults with documented birch pollen allergy were enrolled and randomised into four cohorts. The volunteers received either a single dose or ascending doses of DM-101 or placebo.
It was concluded that the highest of the tested dosing regimens, a biweekly dosing regimen of DM-101 involving 5 ascending doses is safe and well-tolerated by subjects that suffer from seasonal symptoms of birch pollen allergy. Albeit the number of study participants was small, the immunological marker results indicated a favourable change in the markers associated with a protective response.
“In addition to providing safety and immunogenicity data about DM-101, the study results also led us to investigate the effect of formulation on the potency of the allergens. An improved formulation of DM-101 utilising the findings is being tested in preclinical studies and is expected to be ready for the next clinical study that will further investigate the dosing interval and dose levels of DM-101 in terms of safety and efficacy”, says Mattila.
“The allergen immunotherapy market needs safe, reliable and efficient treatment options that meet the current regulatory standards that are becoming more and more challenging in terms of product quality and specifications. Our goal is to offer sustained relief from allergic symptoms with a treatment that can be completed in months instead of years. With the positive results from the First-in-Human clinical study and the promising new formulation we are looking forward to moving towards this goal”, concludes Mattila.
The clinical study was part of AllergyVAX project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 829933.
Immunotherapy in allergy treatment
Allergy is one of the most common chronic conditions in Europe. Today, more than 150 million Europeans suffer from allergic diseases. For one in five patients the condition is severe enough to create a constant threat of a severe allergic reaction or an asthma attack. European Academy of Allergy and Clinical immunology (EAACI) predicts that by 2025 allergy will affect half the population in Europe. Allergies cause social and economic burden such as health care costs, missed school and work days and impact on the daily lives of the patients.
Allergies are generally managed by medication that alleviates the symptoms. The most common medications are antihistamines and corticosteroids. Immunotherapy is the only treatment currently known that affects the mechanism of allergy. It re-educates the immune system to tolerate the allergen, decreasing the need for medication. Immunotherapy can be administered as injections or sublingual tablets or drops, and currently available treatments usually take a few years. The novel immunotherapeutic products that are under development aim for speeding up the treatment as well as improving the safety, efficacy and convenience.
About Desentum Oy: Desentum is a biopharmaceutical company based in Helsinki, Finland. It is specialized in developing a novel type of allergen immunotherapy based on switching the immune system's response to allergens from hypersensitivity to tolerance by utilizing modified hypoallergens. Desentum, founded in 2011, is a spin-off company from VTT Technical Research Centre of Finland Ltd. In 2013 VTT received an EARTO (European Association of Research and Technology Organisations) Innovation Prize for the work behind the immunotherapeutic products. In 2018, Desentum was awarded a 1,9 M€ grant from the highly competitive Horizon 2020 SME instrument for the first-in-human clinical trial and business development. In addition to birch pollen allergy, Desentum develops novel treatments for grass pollen and peanut allergies.
Pekka Mattila, CEO