welcome to pay attention to kellyin drug news
On October 13th, Sanofi announced its tyrosine kinase (BT) tyrosine kinase inhibitor (BT) Results of the Phase 2b Long-Term Extended Study (LTS) trial of multiple sclerosis (RMS), well tolerated for one year, measured by magnetic resonance imaging (MRI), and after 48 weeks of treatment with tolebrutinib. Multiple sclerosis (MS) disease activity reduce. Detailed data will be announced at the 37th European Committee for the Treatment and Research of Multiple Sclerosis (ECTRIMS) from October 13th to 15th, 2021.
Phase 2b LTS trial consists of part A and part B, designed to evaluate the safety and efficacy of tolebrutinib, 98% (122/125) of patients are still receiving at the 48th week treatment. Part A is the double-blind treatment period. Patients continue to use the tolebrutinib dose (5, 15, 30, or 60 mg/day) used in the dose-escalation study. In Part B, the dose of all subjects is changed to 60 mg/day. This is phase 3. Dosage administered in clinical trials.
Safety and effectiveness results:
a. In terms of safety, tolebrutinib has shown sustained good tolerance,And there are no new safety signals. The most common adverse events were headache (10%), new coronavirus infection (9%), upper respiratory tract infection (8%) and nasopharyngitis (7%).
b. At baseline, the average Extended Disability Status Scale (EDSS) score of each treatment group ranged from 2.18 to 2.65. Within 48 weeks of treatment, the average EDSS scores of all treatment groups remained relatively stable. Among them, the average (SD) score at baseline of the maximum dose treatment group was 2.65 (1.22), and the average (SD) score at the 48th week was 2.45 (1.31).
c. During the 48-week treatment period, the annualized recurrence rate (ARR) of patients in the maximum dose treatment group was lower, which was 0.17 (95% CI: 0.10, 0.29). During this period, most patients (89.5%) did not relapse. In the year before the Phase 2b trial, the recurrence rate for these patients was 1.23.
MRI results:
In the maximum dose treatment group, the average number of new Gd-enhanced lesions in the 48th week of the 2b LTS trial was still low (<0.4).>
In addition, Sanofi also provided data on the regulation of tolebrutinib on human microglia. This data supports the ability of tolebrutinib to directly regulate neuroinflammatory processes in the central nervous system (CNS) of .The results of this study extend the previous findings in mouse microglia and show that the use of tolebrutinib in vitro can modulate BTK-dependent inflammatory signals in human microglia and tri-cultures. This research helps to better understand the BTK signaling in neuroinflammation and how BTK inhibitors target neuroinflammation that plays a role in the progression of disability in MS patients.
Currently, 5 BTK inhibitors have been approved for marketing, namely , Johnson & Johnson and AbbVie 's Ibrutinib (listed in 2013), 5 AstraZeneca (Listed in 2017), BeiGene zebutinib (listed in 2019), Ono Pharmaceuticals tirabutinib (listed in 2020) and Nuocheng Jianhua's abutinib (listed in 2020) ). Ibrutinib is a well-deserved leader. It has been approved for more than ten indications worldwide, including tumors and autoimmune diseases. In 2020, Johnson & Johnson and AbbVie will obtain revenues of US$4.228 and US$5.314 billion respectively. Sanofi tolebrutinib is the only BTK inhibitor used in multiple sclerosis, with the ability to cross the blood-brain barrier.
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