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Find Nephrology Drugs in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): KBP-5074

            Therapeutic Area: Nephrology Product Name: KBP-5074

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2020

            Details:

            BLOCK-CKD is a Phase 2b, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of KBP-5074, on top of current therapy, in patients with Stage 3B/4 CKD and uncontrolled hypertension.

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            Lead Product(s): KZR-616

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Jefferies

            Deal Size: $46.7 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 08, 2020

            Details:

            Kezar intends to use the net proceeds from the offering primarily to fund the research and development of its product candidates, acquire or license products or technologies that are complementary to its own.

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            Lead Product(s): CXA-10

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 03, 2020

            Details:

            FIRSTx is a Phase 2, multicenter, randomized, open-label clinical trial evaluating the safety and efficacy of oral CXA-10 to treat immunosuppression-naïve patients 13 years of age and older with biopsy-confirmed primary FSGS.

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            Lead Product(s): Nimacimab

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 28, 2020

            Details:

            U.S. FDA has approved initiation of a phase 2 clinical study of nimacimab, also known as RYI-018, in patients with one of the following renal diseases: diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or immunoglobulin A (IgA) nephropathy.

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            Lead Product(s): KBP-5074

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 21, 2020

            Details:

            Single doses of 0.5 mg KBP-5074 were generally well tolerated in patients with severe CKD, with or without hemodialysis . Overall drug exposure was significantly lower in hemodialyzed patients vs. non-hemodialyzed patients.

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            Lead Product(s): KBP-5074

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 20, 2020

            Details:

            BLOCK CKD is a randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy, safety, and pharmacokinetics of KBP-5074 in patients with moderate-to-severe CKD and uncontrolled hypertension.

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            Lead Product(s): CCX140

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 18, 2020

            Details:

            The LUMINA-1 trial tested CCX140 in primary FSGS subjects. In the study, CCX140 did not demonstrate a meaningful reduction in proteinuria relative to the control group after 12 weeks of blinded treatment.

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            Lead Product(s): Avasopasem manganese

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 13, 2020

            Details:

            Retrospective analysis of Phase 2b trial data demonstrating the potential renal protective activity of lead candidate avasopasem manganese (GC4419), and two ongoing clinical trials evaluating avasopasem, will be presented at the ASCO 2020.

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            Lead Product(s): DM199

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 23, 2020

            Details:

            WI facility to support the trial using its GPEx cell line development technology. DiaMedica intends to initiate enrollment in the study in the next few weeks.