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▎WuXi AppTec content team editor A few days ago, DICE Therapeutics announced that its oral inhibitor DC-806, which targets IL-17, has achieved positive results
in a phase 1 clinical trial 。 These results accelerate the clinical process of the drug, and DICE Therapeutics expects to submit an IND application to the US FDA in the first half of 2023 and initiate a Phase 2b clinical study
.
Psoriasis is a common chronic inflammatory skin disease whose main symptoms include itching, bleeding, and pain, and the skin often appears erythema and scales
.
The treatment cycle of psoriasis is long, the condition is easy to repeat, and may even lead to damage to the appearance, causing a heavy psychological burden to patients, but there is currently no cure for this disease
.
Previous studies have shown that interleukin-17 (IL-17) plays a key role in the pathological mechanism of psoriasis, making it one of
the main research and development targets for psoriasis treatment drugs.
In response to this persistent disease, DICE Therapeutics is developing an oral IL-17 small molecule antagonist, the main candidate of which is DC-806, which researchers hope will achieve similar therapeutic effects
to currently approved parenteral biologics.
Dr.
Tim Lu, Chief Medical Officer of DICE Therapeutics, said in a press release, "Based on the results of the Phase 1 clinical trial, we believe DC-806 has the potential to be a potential 'best-in-class' oral therapy
for psoriasis patients.
For chronic immune diseases like psoriasis, there is a clear need for safe and more effective oral treatments
.
Data from this Phase 1 clinical trial provide early evidence
of potential differences in efficacy, safety, and ease of use of DC-806.
We look forward to advancing DC-806 to Phase 2b clinical trials to optimize dosage and further explore peak efficacy
over longer treatment times.
" "
As WuXi AppTec's CTDMO focused on cell and gene therapies, WuXi Biologics is committed to accelerating and transforming the development, testing, manufacturing and commercialization
of gene and cell therapies and other high-end therapies.
WuXi Biologics can help customers around the world bring more innovative therapies to market sooner rather than later, benefiting patients
.
If you have related business needs, please click the picture below to fill in the specific information
.
in a phase 1 clinical trial 。 These results accelerate the clinical process of the drug, and DICE Therapeutics expects to submit an IND application to the US FDA in the first half of 2023 and initiate a Phase 2b clinical study
.
Psoriasis is a common chronic inflammatory skin disease whose main symptoms include itching, bleeding, and pain, and the skin often appears erythema and scales
.
The treatment cycle of psoriasis is long, the condition is easy to repeat, and may even lead to damage to the appearance, causing a heavy psychological burden to patients, but there is currently no cure for this disease
.
Previous studies have shown that interleukin-17 (IL-17) plays a key role in the pathological mechanism of psoriasis, making it one of
the main research and development targets for psoriasis treatment drugs.
In response to this persistent disease, DICE Therapeutics is developing an oral IL-17 small molecule antagonist, the main candidate of which is DC-806, which researchers hope will achieve similar therapeutic effects
to currently approved parenteral biologics.
The trial is a randomized, double-blind, placebo-controlled clinical study, and it is understood that the trial was divided into three parts: phase 1a trial: a single-dose dose escalation trial (n=40); Phase 1b trial: multiple escalating dose trials (n=32); and Phase 1c proof-of-concept trials (n=32).
Based on the feedback from the trial results, the trial successfully completed the proof of concept and supported the company's advancement of DC-806 as a potential "best-in-class" oral treatment for psoriasis
.
A total of 8 members of the high-dose group (800 mg BID), 13 low-dose group (200 mg BID) and 11 placebo groups
were recruited in the phase 1c trial.
After 4 weeks of treatment, the average percentage reduction in psoriasis lesion area and severity index (PASI) from baseline was 43.
7% in the high-dose group compared with 13.
3% in the placebo group, all of which were statistically significant
.
In addition, analysis of biomarkers showed that both high-dose and low-dose DC-806 demonstrated biological activity, rapid onset of drug action, and dose-dependent drug targeting effects
.
DC-806 showed a good PK curve, and serum concentrations of the drug increased
proportionally to dose throughout the study.
The safety and tolerability of DC-806 was good in all dose groups, all treatment concomitant adverse effects (TEAEs) were classified as mild or moderate, and there was no dose-dependent trend
in the frequency, severity, or type of TEAEs observed.
Image source: 123RF
Dr.
Tim Lu, Chief Medical Officer of DICE Therapeutics, said in a press release, "Based on the results of the Phase 1 clinical trial, we believe DC-806 has the potential to be a potential 'best-in-class' oral therapy
for psoriasis patients.
For chronic immune diseases like psoriasis, there is a clear need for safe and more effective oral treatments
.
Data from this Phase 1 clinical trial provide early evidence
of potential differences in efficacy, safety, and ease of use of DC-806.
We look forward to advancing DC-806 to Phase 2b clinical trials to optimize dosage and further explore peak efficacy
over longer treatment times.
" "
As WuXi AppTec's CTDMO focused on cell and gene therapies, WuXi Biologics is committed to accelerating and transforming the development, testing, manufacturing and commercialization
of gene and cell therapies and other high-end therapies.
WuXi Biologics can help customers around the world bring more innovative therapies to market sooner rather than later, benefiting patients
.
If you have related business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please long press to scan the QR code above, or
