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Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) Announces Topline Resultsfrom DETERMINE Stage 3 Study of LenabasumRelated Links



Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) today announced topline consequences from the Stage 3 DETERMINE study of lenabasum in grownups with the uncommon, varied, autoimmune illness dermatomyositis.

Primary endpoint

The study did not encounter its primary endpoint of Total Improvement Score at Week 28. Advanced TIS standards designate better inclusive development. At Week 28, the lenabasum 20 mg twofold everyday group attained a mean TIS of 28.3 against the control group’s mean TIS of 26.7, p = 0.1965.

Extra pre-specified studies of the general effect on TIS of lenabasum 20 mg twice daily versus control group through Week 52 showed a tendency of the practical consequence of lenabasum, nominal p = 0.0795.

Dermatomyositis patients have typical muscle paleness and demagogic skin participation.

Enhancement in muscle faintness is heavily slanted in the TIS notch. In the general study, advanced TIS notches were seen in those subjects with muscle faintness and were preserved with lenabasum 20 mg twice daily versus the control group.

In the complete study, more excellent enhancement (reduction) in CDASI action scores was seen in subjects with skin engrossment but no muscle faintness who were treated lenabasum 20 mg twice daily against the control group.

Effect of lenabasum on lung role was a subordinate endpoint in this revision. No statistically significant alteration was seen at Week 28 in the lenabasum 20 mg twice daily group versus the control group.

Security statistics

Security statistics presented 86.5% of lenabasum-treated subjects, and 85.9% of control subjects had treatment-emergent opposing proceedings. 11.5% of lenabasum-treated subjects and 5.6% of control subjects had grave opposing proceedings. No lenabasum-treated subject and one control subject stopped study drug because of opposing proceedings connected to study drug. Statistics from this study will be accessible at an imminent medical session.

“We are saddened that the pilot did not meet the key endpoint of TIS at Week 28,” said Barbara White, M.D., Chief Medical Officer and Head of Research at Corbus.

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