On May 9, 2023 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the first quarter ended March 31, 2023 and provided corporate updates (Press release, Aduro Biotech, MAY 9, 2023, View Source [SID1234631223]).

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"During the first quarter of 2023, we continued to advance our pipeline of clinical and preclinical programs for rare, severe chronic kidney diseases. We recently completed full enrollment of the phase 3 ALIGN clinical trial, are on track to initiate the phase 3 BION-1301 IgAN clinical trial mid-year and expect to report topline ALIGN results in the fourth quarter of this year," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We also look forward to the upcoming 60th European Renal Association (ERA) Congress being held June 15th – 18th, where we will present clinical data from the phase 1/2 trial of BION-1301 as well as the phase 1 trial of CHK-336 in healthy volunteers."

Recent Accomplishments and Updates

Atrasentan

Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has potential therapeutic benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. The phase 3 ALIGN trial is evaluating atrasentan in patients with IgAN and the phase 2 AFFINITY basket trial is evaluating atrasentan in patients with proteinuric glomerular diseases.

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Chinook has completed enrollment of the phase 3 ALIGN trial, including 320 patients in the main stratum and 64 patients in the SGLT2 inhibitor (SGLT2i) combination stratum. Following a Type D meeting with the U.S. Food and Drug Administration (FDA), Chinook has agreed to change the primary proteinuria endpoint in the ALIGN study to be evaluated at 36 weeks, and plans to report topline data from this endpoint in the fourth quarter of 2023 to potentially support an application for accelerated approval with the FDA.
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Chinook has completed enrollment of the first four cohorts of the AFFINITY trial, including patients with IgAN, focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors, and is continuing to enroll the fifth cohort of FSGS patients at a 1.5 mg dose of atrasentan. Chinook plans to present data from one or more additional cohorts of the AFFINITY trial in the second half of 2023.
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Chinook is preparing to initiate the phase 2 ASSIST trial evaluating atrasentan in patients with IgAN on stable doses of a renin-angiotensin system inhibitor (RASi) and an SGLT2i. The goal of the ASSIST trial is to generate proteinuria data with the combination that will be available at the time of atrasentan’s launch. More details of the ASSIST trial design will be presented in June at the ERA Congress in Milan.

BION-1301 (Zigakibart)

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 2 development for patients with IgAN. BION-1301’s potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) has been demonstrated clinically in both healthy volunteers and patients with IgAN.

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Chinook has finalized trial design and is completing site and country feasibility and global regulatory interactions to enable initiation of the phase 3 BEYOND trial of BION-1301 in mid-2023. More details of the BEYOND trial design will be presented in June at the ERA Congress in Milan.
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Chinook has completed enrollment of 30 patients in Cohort 2 of Part 3 of the ongoing phase 1/2 trial of BION-1301. Patients in Cohort 2 receive a subcutaneous (SC) dose of 600 mg of BION-1301 every two weeks. Chinook plans to report additional data from Cohorts 1 and 2 in June at the ERA Congress in Milan as well as in the second half of 2023.
CHK-336

CHK-336 is an oral small molecule lactate dehydrogenase A (LDHA) inhibitor with liver-targeted tissue distribution that Chinook is developing for the treatment of patients with primary hyperoxaluria (PH) and other kidney stone disorders driven by endogenous overproduction of oxalate.

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In April 2022 Chinook initiated a phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial in healthy volunteers evaluating the safety, tolerability and pharmacokinetic profile of CHK-336. Initial data from this trial will be presented in June at the ERA Congress in Milan.
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In April 2023 Chinook voluntarily paused dosing in the phase 1 clinical trial of CHK-336 in healthy volunteers to allow for a thorough investigation of a serious adverse event that occurred in a single subject following the first dose in the 125 mg MAD group. Based on information available thus far, we believe the subject may have had a hypersensitivity reaction shortly after receiving their first dose of 125 mg of CHK-336. Comprehensive follow-up of this subject is ongoing, and Chinook is determining next steps for the program.
Corporate

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Chinook recently announced the appointment of Robert W. Azelby to its Board of Directors. Mr. Azelby brings more than 20 years of executive leadership and commercial experience in the biopharmaceutical industry to Chinook, including chief executive officer roles at Eliem Therapeutics and Alder Biopharmaceuticals, as well as chief commercial officer at Juno Therapeutics and commercial positions across Amgen’s nephrology and oncology business units.
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In November 2022, Sairopa B.V., in which Chinook owns approximately a 36 percent equity interest, entered into an exclusive license and option agreement with Exelixis, Inc. for the development of ADU-1805, a monoclonal antibody targeting SIRPα. Under this agreement, Sairopa received an upfront payment of $40.0 million and an additional $35.0 million milestone payment when the FDA cleared Sairopa’s Investigational New Drug (IND) Application for a phase 1 trial of ADU-1805 in adults with advanced solid tumors in the first quarter of 2023.

First Quarter 2023 Financial Results

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Cash Position – Cash, cash equivalents and marketable securities totaled $357.4 million at March 31, 2023, compared to $385.3 million at December 31, 2022.

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Revenue – Revenue for the quarter ended March 31, 2023 was $1.8 million compared to $2.7 million for the same period in 2022. The decrease was primarily due to revenue recognized under Chinook’s license agreement with SanReno.
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Expenses –
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Research and development expenses for the quarter ended March 31, 2023 were $50.9 million compared to $26.3 million for the same period in 2022. The increase was primarily due to higher licensing, contract research and manufacturing costs, employee-related costs, including stock-based compensation expense, as well as spending for consulting, outside services and other costs. These higher costs primarily resulted from completing enrollment of the phase 3 ALIGN trial, startup activities for additional atrasentan and BION-1301 clinical trials and an increase in hiring to support our clinical programs.

General and administrative expenses for the quarter ended March 31, 2023 were $11.4 million compared to $7.9 million for the same period in 2022. The increase was primarily due to higher employee-related costs, including stock-based compensation expense, and higher consulting and outside services costs.

The change in fair value of contingent consideration and contingent value rights liabilities for the quarter ended March 31, 2023 was an expense of $0.5 million compared to a benefit of $1.0 million for the same period in 2022. The increase in this non-cash expense primarily resulted from a change in estimate of the potential future proceeds derived from the Merck collaboration.

Net Loss – Net loss for the first quarter of 2023 was $60.2 million, or $0.85 per basic share, compared to a net loss of $31.7 million, or $0.54 per share for the same period in 2022.