Wednesday, June 12, 2024

ProKidney ends manufacturing pause, has positive clinical trial results

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ProKidney Corp. disclosed in a regulatory filing Monday it resumed U.S. manufacturing on June 1 as part of a clinical trial update to investors on one of its top product therapies.

Manufacturing also resumed at its non-European clinical study sites.

ProKidney is a late clinical-stage cellular therapeutics company focused on chronic kidney disease.

It currently has 80 employees with announced expansion plans at its Winston-Salem operations and a $458 million manufacturing plant in Greensboro.

The company announced in November it was pausing manufacturing to address an audit of its quality management system. ProKidney said that “no safety events are responsible for this pause.”

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The company has said its manufacturing process, which is individualized to each patient’s biopsy sample, requires highly specialized facilities and equipment that meet global regulatory requirements for cellular products.

Modifications to the Phase 3 program and the manufacturing pause will delay patient enrollment in its PROACT 1 and 2 studies until the first half of 2024 as well.

The regulatory filing also cited “positive interim results” from its Phase 2 REGEN-007 trial evaluating the company’s renal autologous cell therapy, rilparencel, in patients with chronic kidney disease caused by diabetes and provided clinical and operational updates.

Clinical trial patients are allocated to two treatment groups using different dosing or injection regimens of rilparencel injections into one or both kidneys.

ProKidney said that as of May 7, group 1 patients with at least 12 months follow-up after the second injection of rilparencel “show stabilized kidney function for 18 months.”

Meanwhile, no rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection.

ProKidney said it expects to receive by June 30 what is known as a “declaration of equivalence” that would allow ProKidney to ship rilparencel to clinical study sites in Europe.

In other clinical updates, ProKidney has resumed screening patients for its PROACT 1 study under an amended protocol that allows for higher-risk patients. For its PROACT 2 study, ProKidney recently activated sites in Spain.

“These are critically important operational milestones for ProKidney,” said Bruce Culleton, ProKidney’s chief executive.

“The interim results from REGEN-007 are promising and reveal the potential of rilparencel to preserve kidney function in patients with moderate to severe chronic kidney disease.

“This is our first clinical study using bilateral kidney dosing and cryopreserved rilparencel replicating our approach in both PROACT 1 and PROACT 2 Phase 3 studies.”

ProKidney reported in May a slightly lower loss in the first quarter at $35.3 million. The company is not generating revenue at this point as a publicly traded company, although it had $4.8 million in interest income during the first quarter.

The company’s continuing acceleration of research and development activities produced a 6.3% jump in operating expenses to $27.2 million, while general and administrative expenses dropped 15.8% to $12.8 million.

Local expansions

ProKidney could not be immediately reached on how the resumption of manufacturing affects its Greensboro and Winston-Salem plans.

ProKidney confirmed June 14, 2023, plans to establish a biomanufacturing plant with staged investments of up to $458 million in Greensboro.

The company pledged to create up to 330 jobs by the end of 2028 at an average annual salary of $74,636. Production has been projected to begin in 2027 at the manufacturing facility within 73 Business Center off Greenbourne Drive near Interstate 73.

On Sept. 8, ProKidney confirmed it will expand its Winston-Salem laboratory, manufacturing and office operations by making a $21 million capital investment and creating 50 jobs by 2027.

The company will add combined about 53,000 square feet at its Empire and Westpoint drives locations with a breakdown of $15 million on building improvements, and $6 million in equipment.

The new jobs would be primarily in manufacturing, engineering and quality control with an average annual salary of at least $72,000, plus benefits.

rcraver@wsjournal.com; 336-727-7376;

@rcraverWSJ

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