Dendrogenix is a Liège-based biopharmaceutical company dedicated to the development of New Chemical Entities (NCEs) called Dendrogenins through early clinical development. These First in class small molecules derived from epoxysterols and biogenic amines possess neuroprotective and neuroregenerative properties and promote neuronal survival. Dendrogenins are designed to address significant unmet medical needs in the field of neurological disorders resulting from synaptic neuronal deficiency, such as hearing loss and, more specifically, presbycusis or age-related hearing loss but also stroke and traumatism brain injury. We met with Stéphane Silvente, CEO and co-founder of the company.
Stéphane Silvente, since 2018, Dendrogenix has been developing innovative molecules, dendrogenins, to address significant unmet medical needs in hearing loss and neurology?
Dendrogenix currently employs around 20 people, including doctors in chemistry and biology, as well as expert consultants in preclinical and clinical pharmaceutical regulatory development. Our company is active in the hearing loss market, for which there are still no approved drugs and for which only sound-amplifying hearing aids are available. The World Health Organization (WHO) estimates that age-related hearing loss, affecting people aged 60 and over, is the most common cause of hearing loss worldwide and will affect more than 500 million people by 2025. Dendrogenix is also a promising company in neurology.
In this second field, Dendrogenix has successfully continued its ‘STROMA’ R&D program, launched in September 2022, and is preparing to deliver very promising preclinical results. This ambitious program covers the indications of ischemic stroke and traumatic brain injury (TBI). The STROMA project has received financial support from the Walloon Region’s Department of Research and Technological Development, which has awarded it a grant of €1.5 million.
At the 2024 SFN meeting in Chicago Dr Quentin Marlier, Head of Biology at Dendrogenix, presented promising results from the first two years of preclinical data in mice treated with its new first-in-class compound, DX243, in stroke and TBI models.
The presentation of these results was very well received by key opinion leaders, such as Prof. Patrick LYDEN, a specialist at the Zilkha Neurogenetic Institute who has joined our precious team of collaborators.
Thus, in the second half of 2025, Dendrogenix began a scientific collaboration based on a series of in vivo experiments conducted simultaneously in Belgium and the United States at Professor LYDEN’s laboratory. This collaboration with this world-renowned specialist, certified by the FDA and EMEA, was made possible thanks to new financial support granted by the Walloon Region in 2025.
2025 was an important and decisive year for Dendrogenix. You began and continued your Phase 1b trial and are about to complete your first clinical trial, launched at the end of 2023, on dendrogenins to combat age-related hearing loss.
Indeed, in the field of deafness, we are finalizing our first-in-human (FIH) single-center clinical study in Liège with our clinical partners at SART TILMAN, the University Hospital of Liège. Phase I is divided into two parts. Part A consists of a single ascending dose study. No systemic adverse effects were observed during this phase, allowing Dendrogenix to confidently continue with phase B throughout 2025.
Part B consisted of a multiple ascending dose study involving a maximum of 24 healthy volunteers. Based on the encouraging and satisfactory results of Phase B, Dendrogenix will be able to make a positive assessment of multiple doses of DX243 tolerability.
In the first quarter of 2026, Dendrogenix will initiate its Phase IIa clinical trial, which will consist of a multiple ascending dose study with a maximum of 24 patients receiving DX243.
This Phase IIa clinical trial will assess the tolerability of the drug candidate in a limited number of patients affected by presbycusis. This will reinforce the robustness of the safety data previously obtained for the drug candidate during Phase I.
Moreover, Phase IIa trial also has advantage of providing preliminary efficacy results of the drug candidate, which are necessary for the design and optimization of Phase IIb trial.
The goal of phase IIb will be to determine the therapeutic dose of the drug candidate on a larger scale.
Can you count on the financial support of key partners for this development project?
This Phase 1/2a clinical trial is receiving financial support from the Walloon Region’s Department of Research and Technological Development (SPW Recherche Wallonne – CLINEAR project), which has provided €2.5 million in funding. Two rounds of fundraising have already been completed, involving several investors such as NOSHAQ and WE, as well as the private company MED-EL, which specializes in electronic hearing aids.
Can your company also count on solid scientific advice?
Dendrogenix’s expertise focuses on the chemistry and biology of dendrogenins, included their innovative mechanism of action, which is recognized by experts in the field of deafness. Some of these experts sit on the company’s scientific advisory board, which regularly calls on them to help it pursue its clinical work in the best possible way. At the same time, Dendrogenix has developed international research partnerships with leading players in the field of deafness and neurology, including world-renowned academic centers such as GIGA-Neurosciences at the University of Liège and the University of Tübingen in Germany.
In addition to its clinical development platform, Dendrogenix has developed expertise in the production process of dendrogenins, especially in their specific medicinal chemistry and biology.
The common goal is the synthesis of new dendrogenins and to evaluate the therapeutic efficacy of these new drug candidates in neurological diseases.
This combined expertise in medicinal chemistry and cell biology has enabled Dendrogenix scientists’ team to set up an innovative technological platform within which:
- i) several in vitro and in vivo models of neurological diseases have been set up, enabling Dendrogenix’ team to file a family of patents over the last four years,
- ii) specific proof-of-concept studies were conducted to test the efficacy of the chemical structures portfolio and evaluate their mechanisms of action.
Dendrogenix can be proud of its achievements!
Does Dendrogenix’s strength also lie in this future potential?
Absolutely! Our company is attentive to market developments and wishes to focus primarily on the field of hearing loss, while remaining open to other potential applications such as brain damage and other neurodegenerative diseases related to mitochondrial dysfunction. In this regard, our company’s chemists and biologists are constantly working to develop and protect the intellectual property resulting from new generations of dendrogenins, as well as their therapeutic applications in new indications for neurodegenerative diseases.
Stéphane Silvente, it is clear that the Dendrogenix team and scientists are essential, but for you, are investors just as important for the development of your company?
As our main objective is to commercialize the product, we want to take it as far as possible in clinical development, at least to the end of phase IIb. Therefore, rather than considering a single transaction involving all of our intellectual property, our strategy is focused on developing different indications through various partnerships.
This action plan is supported by a well-structured syndicate of investors. I must say that I am very satisfied and proud of the composition of our board of directors, which includes sovereign wealth funds such as NOSHAQ, as well as influential figures such as Dr Ingeborg Hochmair, founder and CEO of MED-EL, famous for creating the world’s first microelectronic multichannel cochlear implant.
What are Dendrogenix’s long-term objectives?
Dendrogenix can rely on its academic partnerships and well-advanced clinical trial projects to confidently envisage its medium-term development prospects. Dendrogenix also wishes to extend its expertise in dendrogenins and their derivatives. To do this, we can count on our experienced team to optimize our performance, thanks to the extension of our initial patents and a new generation of dendrogenins, covered by the conversion of Belgian patents into international patents.
Dendrogenix
– Biotechnology company dedicated to the development of dendrogenins up to the early clinical stage
– CEO: Stéphane SILVENTE
– Areas of research: deafness and neurology
– 20 employees based in Liège, Belgium
– Clinical trial underway: DX243 for the treatment of presbycusis – phase Ib
– Preclinical trial underway: STROMA – DX243 for the treatment of stroke-TBI
Dendrogenix
11, avenue de l’Hôpital
B-4000 Liège
Tel.: +32 (0)437 844 94
Email: contact@dendrogenix.com
