Benzinga | Jan 11, 2021 08:10AM EST

Kiniksa Highlights Corporate Priorities And Expected 2021 Milestones

- PDUFA goal date of March 21, 2021 for rilonacept in recurrent pericarditis -

- Data from Phase 2 portion of mavrilimumab Phase 2/3 trial in severe COVID-19 pneumonia and hyperinflammation expected in 1H 2021 -

- Final Phase 1 KPL-404 data expected in 1H 2021 -

HAMILTON, Bermuda, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) (Kiniksa), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today highlighted its corporate priorities and expected 2021 milestones. Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa will provide further detail in a corporate presentation at the Virtual 39th Annual J.P. Morgan Healthcare Conference today, Monday, January 11, 2021 at 4:30 p.m. Eastern Time.

"2020 was marked by significant progress across our entire pipeline, setting the stage to build long-term value across our portfolio," said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. "Moving forward, 2021 has the potential to be a transformational year for Kiniksa with multiple catalysts expected across our pipeline, notably with the potential commercial launch of rilonacept in recurrent pericarditis in the first half of the year. As we focus on our launch readiness preparations, our commitment to bringing novel therapies to patients with unmet need remains at the core of our goals."

Expected 2021 Milestones

Rilonacept (IL-1? and IL-1? cytokine trap)

* Kiniksa's Prescription Drug User Fee Act (PDUFA) goal date for rilonacept in recurrent pericarditis is March 21, 2021, as assigned by the U.S. Food and Drug Administration (FDA) upon the acceptance of the supplemental Biologics License Application (sBLA), with priority review. If approved by the FDA, Kiniksa expects the potential commercial launch of rilonacept in recurrent pericarditis in the first half of 2021 and consequently would evenly split profits on sales of all approved indications in the United States, including cryopyrin-associated periodic syndromes (CAPS) and deficiency of IL-1 receptor antagonist (DIRA), with Regeneron Pharmaceuticals, Inc. (Regeneron).

Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFR?)

* Kiniksa plans to provide next steps for the development of mavrilimumab, including for giant cell arteritis (GCA), in the first half of 2021.

* Kiniksa is conducting a Phase 2/3 clinical trial in severe COVID-19 pneumonia and hyperinflammation. The company expects to provide data from the Phase 2 portion of the trial in the first half of 2021.

Vixarelimab (monoclonal antibody inhibitor of signaling through OSMR?)

* Kiniksa is conducting a Phase 2b dose-ranging trial of vixarelimab in prurigo nodularis. The Phase 2b trial is expected to enroll approximately 180 patients experiencing severe pruritus. Patients will be randomized to receive vixarelimab or placebo subcutaneously (SC) once-monthly.

KPL-404 (monoclonal antibody inhibitor of signaling between CD40 and CD40L)

* Full receptor occupancy through Day 29 shown in preliminary Phase 1 data from the single-ascending dose clinical trial of KPL-404 in healthy volunteers at the 3 mg/kg intravenous (IV) dose. This corresponded with complete suppression of the T-cell Dependent Antibody Response (TDAR) to keyhole limpet hemocyanin (KLH) through Day 29.

* The data to-date support further evaluation in patients, including potential monthly IV or SC administration. Kiniksa expects final data and safety follow-up from all cohorts in the first half of 2021.

Financial Guidance

Kiniksa ended 2020 with approximately $323 million in cash, cash equivalents and short-term investments (unaudited). The company expects that these cash reserves will fund its current operating plan into 2023.