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▎WuXi AppTec Content Team Editor Not long ago, Nimbus Therapeutics released positive top-line results
of a selective tyrosine kinase 2 (TYK2) allosteric inhibitor in a Phase 2b clinical trial.
Data analysis showed that patients with moderate to severe plaque psoriasis had significantly improved psoriasis lesion area and severity index after treatment, and the safety was good
.
NDI-034858 is an allosteric inhibitor of TYK2 developed by Nimbus, and in preclinical studies, NDI-034858 has demonstrated excellent functional selectivity and broad therapeutic range
.
In a Phase 1 clinical study, NDI-034858 demonstrated good tolerability, a dose-dependent trend of exploratory clinical activity, and pharmacokinetic characteristics
supporting once-daily solid oral administration.
This Phase 2b clinical trial is a randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of NDI-034858 in patients with moderate to severe plaque psoriasis with the primary endpoint of the proportion of patients achieving PASI-75 (at least 75% improvement in psoriasis area and severity index), meaning that at week 12 of the trial, as measured by psoriasis area and severity index, Participants had a 75% improvement
in their lesions.
According to the newly released data, the study met the primary efficacy endpoint
.
Compared with placebo, the proportion of patients in the treatment group with improved lesions was significantly higher at 12 weeks, and the difference was statistically significant
.
In addition, the study met other endpoints and its safety profile was consistent with
that of other drugs in its class.
"We are pleased to report the success of our Phase 2b trial in psoriasis patients, which supports NDI-034858's potential
as a 'best-in-class' in a new class of TYK2 allosteric inhibitors.
In addition, consistent safety data observed in this study reinforce this TYK2 inhibitor as a unique type of non-JAK therapy
.
I want to thank the patients, our researchers, and collaborators who made this research possible
.
Dr.
Bhaskar Srivastava, vice president of clinical research and development at Nimbus, said
.
Dr.
April Armstrong, professor of dermatology at the University of Southern California, who led the trial and led the trial, said in a press release: "Nimbus' Phase 2b study yields encouraging preliminary data.
It is further proved that TYK2 allosteric inhibitors can provide effective and safe treatment
for psoriasis patients.
I look forward to seeing how the excellent clinical performance of NDI-034858 continues to benefit psoriasis patients and the broader autoimmune disease community who may benefit
from this unique therapy.
" "
In addition to psoriasis, Nimbus is conducting a Phase 2b trial to evaluate the efficacy of NDI-034858 in active psoriatic arthritis and intends to initiate Phase 3 clinical studies against psoriasis, as well as future trials
in other autoimmune diseases such as inflammatory bowel disease and lupus.
The company said it plans to release more details
about the Phase 2b trial at a future medical conference.
of a selective tyrosine kinase 2 (TYK2) allosteric inhibitor in a Phase 2b clinical trial.
Data analysis showed that patients with moderate to severe plaque psoriasis had significantly improved psoriasis lesion area and severity index after treatment, and the safety was good
.
NDI-034858 is an allosteric inhibitor of TYK2 developed by Nimbus, and in preclinical studies, NDI-034858 has demonstrated excellent functional selectivity and broad therapeutic range
.
In a Phase 1 clinical study, NDI-034858 demonstrated good tolerability, a dose-dependent trend of exploratory clinical activity, and pharmacokinetic characteristics
supporting once-daily solid oral administration.
This Phase 2b clinical trial is a randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of NDI-034858 in patients with moderate to severe plaque psoriasis with the primary endpoint of the proportion of patients achieving PASI-75 (at least 75% improvement in psoriasis area and severity index), meaning that at week 12 of the trial, as measured by psoriasis area and severity index, Participants had a 75% improvement
in their lesions.
According to the newly released data, the study met the primary efficacy endpoint
.
Compared with placebo, the proportion of patients in the treatment group with improved lesions was significantly higher at 12 weeks, and the difference was statistically significant
.
In addition, the study met other endpoints and its safety profile was consistent with
that of other drugs in its class.
"We are pleased to report the success of our Phase 2b trial in psoriasis patients, which supports NDI-034858's potential
as a 'best-in-class' in a new class of TYK2 allosteric inhibitors.
In addition, consistent safety data observed in this study reinforce this TYK2 inhibitor as a unique type of non-JAK therapy
.
I want to thank the patients, our researchers, and collaborators who made this research possible
.
Dr.
Bhaskar Srivastava, vice president of clinical research and development at Nimbus, said
.
Dr.
April Armstrong, professor of dermatology at the University of Southern California, who led the trial and led the trial, said in a press release: "Nimbus' Phase 2b study yields encouraging preliminary data.
It is further proved that TYK2 allosteric inhibitors can provide effective and safe treatment
for psoriasis patients.
I look forward to seeing how the excellent clinical performance of NDI-034858 continues to benefit psoriasis patients and the broader autoimmune disease community who may benefit
from this unique therapy.
" "
In addition to psoriasis, Nimbus is conducting a Phase 2b trial to evaluate the efficacy of NDI-034858 in active psoriatic arthritis and intends to initiate Phase 3 clinical studies against psoriasis, as well as future trials
in other autoimmune diseases such as inflammatory bowel disease and lupus.
The company said it plans to release more details
about the Phase 2b trial at a future medical conference.
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.
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