DM-101PX / Desentum - LARVOL DELTA

Study to Evaluate Safety and Efficacy of DM-101PX in Adults With Birch Pollen Allergy (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Desentum Oy

New P2 trial • Allergic Rhinitis • Allergy • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

RANDOMIZED, PLACEBO CONTROLLED PHASE 1B TRIAL OF APL-18881, A NOVEL FGF21 AND GLP-1 BISPECIFIC DUAL RECEPTOR AGONIST, EVALUATING MEASURES OF METABOLIC AND LIVER HEALTH IN PATIENTS WITH TYPE 2 DIABETES AFTER 5 WEEKS OF TREATMENT (AASLD 2025) - " HEC88473-DM-101 was a single-centre, randomized, double-blind, placebo-controlled Phase 1b trial to evaluate the safety, tolerability, PK, and PD of APL-18881. APL-18881 demonstrated robust dose-dependent improvement in measures of metabolic and liver health in a Phase 1b MAD trial in participants with T2D after 5 weeks of treatment. The effects observed on MRI-PDFF and liver stiffness support the potential of APL-18881 to be an effective therapeutic in SLD."

Clinical • P1 data • Diabetes • Hepatology • Metabolic Disorders • Type 2 Diabetes Mellitus • FGF21

Subcutaneous AIT with a thermosensitive hydrogel formulation containing genetically engineered Bet v 1 is safe and induces a strong protective immune response in birch pollen allergic patients (EAACI 2025) - "Moreover, the immune response was shown to block Bet v 1-mediated basophil activation and it sustained for at least 6 months after treatment. Conclusion The approach to design highly efficient allergy vaccines based on subtly modified allergens formulated with a thermosensitive hydrogel is endorsed by clinical results showing that short-course treatment with DM-101PX is safe, well tolerated, and able to induce a strong and functional immune response."

Clinical • Immunology

Detection of blocking antibodies using a basophil activation test in sera from allergic patients treated with investigational birch pollen allergy vaccine DM-101PX (EAACI 2025) - "No reduction in activation was seen in the BA-BAT with post-treatment sera from patients that had been treated with placebo. Conclusion The induction of high levels of Bet v 1-IgG4 in patients treated with DM-101PX was found to be associated with a strong potential to block Bet v 1-mediated basophil activation, which suggests that the IgG4 antibodies induced by DM-101PX can functionally inhibit IgE-mediated activation of effector cells."

Clinical • Allergy • Immunology • CD63

Desentum Reports Strong Safety and Immunological Data From Phase 1 Clinical Study With Investigational Birch Pollen Allergy Vaccine DM-101PX (Businesswire) - P1 | N=30 | NCT06037148 | Sponsor: Desentum Oy | "Desentum Oy...announces positive clinical data with birch pollen allergy vaccine DM-101PX. The short-course treatment was found to be safe and well tolerated in birch pollen allergic patients and to induce a very strong and sustained allergen-specific IgG4 response....The treatment induced a robust allergen-specific IgG4 response, which was found to be associated with effective blocking of IgE-mediated basophil activation. Elevated allergen-specific IgG4 levels and IgE-blocking activity were still detectable in patients’ blood samples at a follow-up visit 28–37 weeks after completion of the treatment indicating that DM-101PX induces a sustained immune response, which is expected to protect against allergic symptoms....'Based on the positive data from Phase 1, we have decided to advance the product into Phase 2 clinical trials in which the clinical effects of treatment with DM-101PX will be investigated.'"

P1 data • Allergy • Immunology

Optimization of Naringin Extraction, Synthesis of Dihydrochalcone and Its Effects on Reducing Blood Lipid Levels In Vitro. (PubMed, Molecules) - "Naringin was purified to obtain naringin-refined products using DM101 macroporous adsorption resin...We measured the effects of different concentrations of naringin dihydrochalcone on intracellular lipids in denatured HepG2 cells and further validated the lipid-lowering effect of naringin at the cellular level. The results showed that naringin dihydrochalcone has a potential application in functional foods for lowering blood lipids."

Journal • Preclinical

Poloxamer formulation for allergen immunotherapy reduces systemic allergic reactions in a mouse model (EAACI 2024) - "Conclusion Formulation of DM-101 with P338 reduces its potential to induce systemic allergic reactions and allows the application of higher doses of DM-101 in Bet v 1-sensitized mice. Treatment of Bet v 1-sensitized mice with a high dose of poloxamer-formulated DM-101 also showed a favorable immune response as it did not induce Bet v 1-sIgE and it prevented the induction of pro-inflammatory cytokines upon a challenge with birch pollen extract."

Preclinical • Allergy • Immunology

Development of a thermosensitive poloxamer formulation designed to provide a controlled release of the active pharmaceutical ingredient in birch pollen allergen immunotherapy (EAACI 2024) - "Conclusion The measured characteristics support the use of DM-101PX as an injectable solution for subcutaneous allergen immunotherapy. The poloxamer formulation supports the encapsulation of the allergen into a hydrogel at body temperature and the controlled release of the allergen in its native form upon injection."

Immunology

A Monocarbonyl Curcuminoid Derivative Inhibits the Activity of Human Glutathione Transferase A4-4 and Chemosensitizes Glioblastoma Cells to Temozolomide. (PubMed, Pharmaceuticals (Basel)) - "Among the curcumin derivatives studied, three proved to be the most potent inhibitors, in the order DM151 > DM101 > DM100, with IC50 values of 2.4 ± 0.1 μM, 12.7 ± 1.1 μΜ and 16.9 ± 0.4 μΜ, respectively. The results revealed that DM151 displays considerably higher cytotoxicity against both glioblastoma cell lines, while the glioblastoma cytotoxicity of DM148 was very limited. Furthermore, low and non-toxic doses of DM151 sensitized U-251 MG cells to the first-line glioblastoma chemotherapeutic temozolomide (TMZ), allowing us to propose for the first time that hGSTA4-4 inhibitors may be attractive therapeutic partners for TMZ to optimize its clinical effect in glioblastoma chemotherapy."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Desentum Oy | Active, not recruiting ➔ Completed

Trial completion • Allergy • Immunology

Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Desentum Oy | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergy • Immunology

Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Desentum Oy

New P1 trial • Allergy • Immunology

Optimisation of the Extraction Process of Naringin and Its Effect on Reducing Blood Lipid Levels In Vitro. (PubMed, Molecules) - "DM101 macroporous adsorption resin was used to purify naringin...In vitro determination of the lipid-lowering activity of naringin was also conducted. These results showed that naringin has potential applications as a functional food for lowering blood lipid levels."

Journal • Preclinical

Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy (clinicaltrials.gov) - P1; N=27; Completed; Sponsor: Desentum Oy; Active, not recruiting ➔ Completed

Clinical • Trial completion • Allergy • Immunology

Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy (clinicaltrials.gov) - P1; N=27; Active, not recruiting; Sponsor: Desentum Oy; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Allergy • Immunology

Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: Desentum Oy; Suspended ➔ Recruiting; N=46 ➔ 27; Trial completion date: Aug 2020 ➔ Aug 2021; Trial primary completion date: Jul 2020 ➔ Jul 2021

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Allergy • Immunology

Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy (clinicaltrials.gov) - P1; N=46; Suspended; Sponsor: Desentum Oy; Recruiting ➔ Suspended

Clinical • Trial suspension

Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy (clinicaltrials.gov) - P1; N=46; Recruiting; Sponsor: Desentum Oy

Clinical • New P1 trial