Pipeline

Pioneering a new paradigm for drug development

Our goal is to develop first-in-class, innovative therapies for indications with significant unmet medical needs, including autoimmune and fibrotic diseases, oncology and genetic diseases.

Autoimmune and Fibrotic Diseases Oncology Genetic Diseases
Pre-Clinical Phase 1 Phase 2 Phase 3
KD025 in Psoriasis Vulgaris

KD025 is an orally available, selective small molecule inhibitor of ROCK2 (Rho-associated coiled-coil kinase 2), a molecular target in multiple autoimmune, fibrotic and neurodegenerative diseases.

Phase 2
Ongoing randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability and activity of KD025 in subjects with moderate to severe psoriasis.

KD025 in Idiopathic Pulmonary Fibrosis

KD025 is an orally available, selective small molecule inhibitor of ROCK2 (Rho-associated coiled-coil kinase 2), a molecular target in multiple autoimmune, fibrotic and neurodegenerative diseases.

Phase 2
Ongoing study of KD025 in idiopathic pulmonary fibrosis.

KD025 in Chronic Graft-Versus-Host Disease

KD025 is an orally available, selective small molecule inhibitor of ROCK2 (Rho-associated coiled-coil kinase 2), a molecular target in multiple autoimmune, fibrotic and neurodegenerative diseases.

Phase 2
Ongoing study of KD025 in chronic graft-versus-host disease.

Tesevatinib in Non-Small Cell Lung Cancer

Tesevatinib is an oral, reversible and potent tyrosine kinase inhibitor (TKI) with demonstrated clinical activity against epidermal growth factor receptor (EGFR). Tesevatinib is highly penetrant of the blood-brain barrier, which separates the circulating blood from the brain, and accumulates in the leptomeninges (membranes that protect the brain and spinal cord) and kidneys.

Phase 2
Ongoing study of tesevatinib in subjects with non-small cell lung cancer (NSCLC) with activating EGFR mutations and brain metastases or leptomeningeal disease.

Tesevatinib in Glioblastoma

Tesevatinib is an oral tyrosine kinase inhibitor (TKI) designed to block key molecular drivers of tumor growth, metastases and drug resistance. Tesevatinib has been observed in preclinical studies to cross the blood-brain barrier, which separates the circulating blood from the brain. In preclinical and early clinical studies, we have observed tesevatinib’s activity against epidermal growth factor receptor (EGFR), a cell surface receptor, and its accumulation in the lungs, leptomeninges (membranes that protect the brain and spinal cord) and kidneys.

Phase 2
Ongoing study of tesevatinib in glioblastoma.

Tesevatinib in Autosomal Dominant Polycystic Kidney Disease

Tesevatinib is an oral, reversible and potent tyrosine kinase inhibitor (TKI) with demonstrated clinical activity against epidermal growth factor receptor (EGFR). Tesevatinib is highly penetrant of the blood-brain barrier, which separates the circulating blood from the brain, and accumulates in the leptomeninges (membranes that protect the brain and spinal cord) and kidneys.

Phase 2a
Ongoing safety, pharmacokinetics and dose-finding study of tesevatinib in subjects with autosomal dominant polycystic kidney disease.

Tesevatinib in Autosomal Recessive Polycystic Kidney Disease

Tesevatinib is an oral, reversible and potent tyrosine kinase inhibitor (TKI) with demonstrated clinical activity against epidermal growth factor receptor (EGFR). Tesevatinib is highly penetrant of the blood-brain barrier, which separates the circulating blood from the brain, and accumulates in the leptomeninges (membranes that protect the brain and spinal cord) and kidneys.

Phase 1
Planned study of tesevatinib in autosomal recessive polycystic kidney disease.

KD034 in Wilson’s Disease

KD034 is our portfolio of trientine hydrochloride formulations for the treatment of Wilson’s disease.

ANDA Submitted
Abbreviated New Drug Application (ANDA) for bottled generic capsule formulation of Syprine (trientine hydrochloride) submitted to the U.S. Food and Drug Administration (FDA) in December 2016

Stability and Bioequivalence Studies
Completed stability and bioequivalence studies of KD034.