Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)’s Phase 3 DETERMINE Clinical Study Of Lenabasum Unable To Achieve Primary Objective of TIS At Week 28

Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) posted topline results of Phase 2 DETERMINE Clinical trial of Lenabasum in patients with heterogeneous and rare ADD (autoimmune disease dermatomyositis).

Unable to satisfy the primary objective

Corbus could not achieve its primary objective of TIS (Total Improvement Score) at week 28. The daily administration of Lenabasum 20 mg twice achieved a TIS of 28.3 against the group mean of TIS of 26.7. 

Patients with dermatomyositis experienced inflammatory skin and muscle weakness during the Phase 3 clinical study. 

The company enrolled two types of patients in the clinical study: dermatomyositis with minor muscle weakness, skin involvement; and classic dermatomyositis with skin involvement and muscle weakness. A higher TIS score indicates improvement in MW (muscle weakness). 

Corbus demonstrated higher TIS in patients with muscle weakness and cured with 20 mg of lenabasum against the control group with nominal p=0.0302. 

CDASI (Cutaneous Dermatomyositis Activity and Severity Index) activity score is the secondary objective in this clinical trial. It is designed to evaluate ISI (inflammatory skin involvement) in dermatomyositis. 

After administering lenabasum daily twice with a 20 mg dose, the company achieved significant improvement in CDASI activity scores in patients with no muscle weakness but skin involvement. 

The company did not observe any effect on the lungs functioning when patients are treated using 20 mg of lenabasum daily.

Corbus will present the data of the Phase 3 clinical trial at the forthcoming medical conference. 

The company’s CMO, Barbara White, is disappointed because the phase 3 clinical trial of lenabasum did not satisfy the primary endpoint at week 28. 

Expands pipeline into Fibrotic Diseases and cancer

Corbus expanded its pipeline by licensing CRB-602 and CRB-601, the two innovative mAbs (monoclonal antibodies). 

The mAbs will target integrins to prevent growth factor β transformation. It diversifies and strengthens its immunology pipeline for cancer, metabolic, fibrotic, and inflammatory diseases. 

 Dr. Stephen Nishimura and his team have designed an anti-αvβ8 mAb – CRB-601. 

Corbus will develop CRB-601 to treat solid tumors in combination therapy using its checkpoint inhibitors. CRB-601 inhibits TGFβ activation. The company plans to begin phase 1 clinical studies in 2022. 

Panorama Research Inc developed CRB-602 to inhibit αvβ8 and αvβ6. 

The company holds investments and a cash balance of $125 million at the end of Q1 2022.