tregalizumab (BT-061) / ADMA Biologics, T-Balance Therapeutics - LARVOL DELTA

Epigenetic regulation of early and late asthmatic reactions in allergic asthma (EAACI 2023) - "Method As part of the AMG study Effects of tregalizumab on allergen-induced airway responses and airway inflammation in asthmatic patients (Eudrac-CT number 2020-000585-41), 34 patients (age: median 26 (18 - 38) years) with mild asthma and HDM using bronchial allergen challenge (BAP) were investigated...Network analysis revealed that these miRNAs play a role in Toll-like and T-cell receptor signaling as well as in TGF-β signaling. Conclusion Distinct miRNAs are potential biomarkers and could be used to diagnose LAR and future miRNA therapeutics"

IO biomarker • Allergy • Immunology • Inflammation • MIR146A • MIR15A • MIR374A • MIR96 • TGFB1

Tregulaire: Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients (clinicaltrials.gov) - P2 | N=42 | Completed | Sponsor: T-Balance Therapeutics GmbH | Active, not recruiting ➔ Completed

Trial completion • Allergy • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Tregulaire: Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients (clinicaltrials.gov) - P2; N=42; Active, not recruiting; Sponsor: T-Balance Therapeutics GmbH; Recruiting ➔ Active, not recruiting; Trial completion date: Oct 2021 ➔ Jan 2022; Trial primary completion date: Sep 2021 ➔ Dec 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Allergy • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis. (PubMed, Ann Rheum Dis) - "This SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR's RA management recommendation."

Clinical • Journal • Immunology • Rheumatoid Arthritis • Rheumatology

"Global T-cell Surface Glycoprotein CD4 Pipeline Insights 2020: CEL-1000, Forigerimod Acetate, Ibalizumab, M-48U1, MAX-16H5, SAR-441236, TMB-360, TMB-365, & Tregalizumab - https://t.co/guyiBzPH8C https://t.co/HcqgWElC5t" (@NewsFromBW)

Clinical • CD4

Tregulaire: Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients (clinicaltrials.gov) - P2; N=42; Recruiting; Sponsor: T-Balance Therapeutics GmbH

Clinical • New P2 trial • Allergy • Asthma • Inflammation • Respiratory Diseases

Biotest presents the results of a Phase II study of tregalizumab (BT-061) at the American College of Rheumatology (ACR) Annual Meeting in San Diego (Biotest Press Release) -

P2, N=176; NCT01481493; Sponsor: Biotest; "Biotest AG today announced the presentation of efficacy and safety results from the Phase II study '979' at the Annual Meeting of the American College of Rheumatology (ACR) in San Diego, United States....ACR 20 responses (improvement of disease activity by at least 20%) were observed in up to 56% of patients treated with tregalizumab, and up to 37% and 7% of patients had improvements of disease activity of 50% (ACR 50) or 70% (ACR 70) respectively. The good tolerability of tregalizumab (BT-061) observed in previous trials was also confirmed in this trial; P2b, N=300; TREAT 2b; "The target recruitment for this clinical trial is more than 300 patients....The treatment of the first patients will start within the next days."

Anticipated target enrollment • Anticipated trial initiation date • Conference • P2 data • Immunology • Rheumatoid Arthritis

Biotest: Q3 FY 2015 Results (Biotest) - "Tregalizumab (BT-061) – Status and Next Steps"; "ACR response Week 12"; "ACR response Week 24"; "BT-061 was biologically active but did not translate into medical benefit"

P2 data • Rheumatoid Arthritis

Biotest: Q3 2013 Results (Biotest) - "ACR scores achieved at week 13 up to: ACR 20: 56%, ACR 50: 37%, ACR 70: 7%"; "Good tolerability observed in previous trials confirmed"; "Pharmacodynamic data indicate that higher doses of Tregalizumab could provide even higher efficacy"

P2 data • Rheumatoid Arthritis

Q2 '11 results (Biotest) - Anticipated data for BT-061 psoriasis study (Study No 973) in H2 '11

Anticipated P2 data • Psoriasis

Tregalizumab (BT-061) shows efficacy in chronic plaque psoriasis (Biotest) - P2, N=49; Highest clinical efficacy, measured by PASI score was observed in group receiving 100mg dose; Evaluation of effectiveness of treatment & during follow-up (best result) resulted in 71.4% of pts improved by 50% (PASI 50), with 57.1% of pts had improved by 75% (PASI 75) & 14.3% of pts had improved by 90% SC (PASI 90), both at application of 100mg; Further studies in psoriasis to be executed only after completion of P2b studies in RA

P2 data • Psoriasis

Use of a biologic marker for an integrated pharmacodynamic and clinical analysis to inform further clinical development, including dose selection for the phase 2b trial - Treat 2b - of tregalizumab in rheumatoid arthritis (ACR-ARHP 2013) - Presentation time: Monday, October 28, 2013; 8:30 am - 4:00 pm; Abstract #1412; P2b, N=112; NCT01481493; "The interim clinical analysis of...112 patients indicated efficacy vs. placebo (ACR20/50/70 responses at Week 13). The most pronounced effects were seen for tender and swollen joint counts. In Study 979 tregalizumab was well tolerated with no major safety findings, no CD4 cell depletion was observed."

Biomarker • P2 data • Immunology • Rheumatoid Arthritis

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