Kiniksa Pharmaceuticals announces Phase 2/3 trial for KPL-387, targeting recurrent pericarditis, expected mid-2025. Data available in late 2026.
Quiver AI Summary
Kiniksa Pharmaceuticals announced that it is set to initiate a Phase 2/3 clinical trial for KPL-387, a monoclonal antibody targeting recurrent pericarditis, in mid-2025, with Phase 2 data anticipated in the second half of 2026. KPL-387 is designed for monthly subcutaneous dosing, which the company believes could enhance treatment options for patients. The trial will include a dose-focusing portion with up to 80 participants and a pivotal portion with about 85 participants, evaluating efficacy primarily through time to treatment response and pericarditis recurrence. Kiniksa's executives will provide more information during a presentation at the Jefferies 2025 Global Healthcare Conference today.
Potential Positives
- KPL-387 Phase 2/3 trial is on track to initiate in mid-2025, indicating progress in the drug development pipeline.
- Phase 1 data supports the profile for monthly dosing, which could enhance patient compliance and treatment options.
- KPL-387 has the potential to offer a meaningful addition to therapeutic options for patients with recurrent pericarditis, addressing an unmet medical need.
- The company will present at the Jefferies 2025 Global Healthcare Conference, which may raise visibility and investor interest in Kiniksa and its pipeline drugs.
Potential Negatives
- The projected timeline for initiating the Phase 2/3 clinical trial has been pushed to mid-2025, indicating a delay in advancing KPL-387 to market, which may lead to missed opportunities in a competitive therapeutic space.
- The expectation for Phase 2 trial data has been set for the second half of 2026, suggesting a lengthy wait for results that could impact investor confidence and prolong financial uncertainty.
- The press release includes numerous forward-looking statements that highlight potential risks, including difficulties in patient enrollment and challenges with regulatory approval, indicating that the company faces significant uncertainties ahead.
FAQ
What is the purpose of the KPL-387 Phase 2/3 trial?
The trial aims to evaluate the efficacy and safety of KPL-387 for treating recurrent pericarditis.
When will the KPL-387 Phase 2/3 trial begin?
The KPL-387 Phase 2/3 trial is expected to initiate in mid-2025.
What is the expected timeline for Phase 2 data?
Phase 2 data from the trial is anticipated in the second half of 2026.
How does KPL-387 work in the body?
KPL-387 binds to the interleukin-1 receptor 1 (IL-1R1), inhibiting IL-1α and IL-1β signaling.
Where can I view the presentation from the Jefferies conference?
A live webcast and replay of the presentation will be available on Kiniksa’s website within 48 hours.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$KNSA Insider Trading Activity
$KNSA insiders have traded $KNSA stock on the open market 34 times in the past 6 months. Of those trades, 0 have been purchases and 34 have been sales.
Here’s a breakdown of recent trading of $KNSA stock by insiders over the last 6 months:
- MARK RAGOSA (CHIEF FINANCIAL OFFICER) has made 0 purchases and 10 sales selling 190,006 shares for an estimated $4,612,862.
- ROSS MOAT (CHIEF COMMERCIAL OFFICER) has made 0 purchases and 5 sales selling 115,650 shares for an estimated $2,919,230.
- SANJ K PATEL (CHAIRMAN & CEO) has made 0 purchases and 8 sales selling 99,586 shares for an estimated $2,709,948.
- EBEN TESSARI (CHIEF OPERATING OFFICER) has made 0 purchases and 8 sales selling 87,426 shares for an estimated $1,823,925.
- MICHAEL R MEGNA (CHIEF ACCOUNTING OFFICER) has made 0 purchases and 2 sales selling 26,698 shares for an estimated $674,193.
- JOHN F. PAOLINI (CHIEF MEDICAL OFFICER) sold 200 shares for an estimated $5,400
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$KNSA Hedge Fund Activity
We have seen 1 institutional investors add shares of $KNSA stock to their portfolio, and 1 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- HARBOR CAPITAL ADVISORS, INC. removed 20,371 shares (-20.8%) from their portfolio in Q1 2025, for an estimated $452,439
- GOODMAN ADVISORY GROUP, LLC added 1,363 shares (+inf%) to their portfolio in Q1 2025, for an estimated $30,272
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
– KPL-387 Phase 2/3 trial on track to initiate in mid-2025; Phase 2 data expected in 2H 2026 –
– KPL-387 Phase 1 single ascending dose data support profile for monthly dosing –
– Presentation and webcast at Jefferies 2025 Global Healthcare Conference scheduled for 12:50 pm ET today–
LONDON, June 05, 2025 (GLOBE NEWSWIRE) --
Kiniksa Pharmaceuticals International, plc
(Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today announced details for its planned Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis, expected to initiate in the middle of 2025. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines interleukin-1α (IL-1α) and interleukin-1β (IL-1β).
“We leveraged our expertise in this indication and experience with the RHAPSODY study design to plan this pivotal phase 2/3 study. We believe KPL-387 could provide a meaningful addition to the therapeutic options available to patients,” said John F. Paolini, M.D., Ph.D., FACC, Chief Medical Officer of Kiniksa. “We are eager to advance KPL-387, with its target profile of monthly dosing in a single subcutaneous injection in a liquid formulation, through this pivotal Phase 2/3 clinical trial and to patients in need. We expect to initiate the study in the middle of this year, with data from the dose-focusing portion expected in the second half of 2026.”
Phase 2/3 Clinical Trial of KPL-387 in Recurrent Pericarditis
Kiniksa is on track to initiate a Phase 2/3 clinical trial designed to evaluate the efficacy and safety of KPL-387 administered subcutaneously (SC) in patients with recurrent pericarditis. The trial will consist of three overlapping parts combined into a single protocol: a dose-focusing portion (Phase 2), a pivotal portion (Phase 3), and long-term extensions (LTE).
The dose-focusing portion of the trial will enroll up to approximately 80 participants with recurrent pericarditis randomized in a 1:1:1:1 ratio to receive KPL-387 300 mg SC biweekly, 300 mg SC monthly, 100 mg SC biweekly, and 100 mg SC monthly. The primary efficacy endpoint is time to treatment response at Week 24. Subsequently, active, enrolled participants may be eligible to enter an LTE.
Following the dose-focusing portion, enrollment of up to approximately 85 patients with recurrent pericarditis into the pivotal portion of the clinical trial will commence. In the first period, a single-blind run-in (RI), all participants will receive KPL-387 while conventional oral pericarditis medications are weaned and discontinued. Participants achieving Clinical Response in the RI period will then be randomized in a 1:1 ratio to receive either KPL-387 or placebo in an event-driven, double-blind, randomized withdrawal (RW) period. The primary efficacy endpoint is time to first-adjudicated pericarditis recurrence during the RW period. Participants in the RW period may be eligible to enter an LTE.
The Phase 2/3 clinical trial design is supported by data from the Phase 1 first-in-human single ascending dose study.
Presentation Information
Ross Moat, Chief Commercial Officer, and Dr. John Paolini, Chief Medical Officer, will provide a corporate presentation at the Jefferies 2025 Global Healthcare Conference at 12:50 p.m. Eastern Time on Thursday, June 5, 2025.
A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website at
www.kiniksa.com
. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.
About Kiniksa
Kiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit
www.kiniksa.com
.
About KPL-387
KPL-387 is an independently developed, investigational, fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of the cytokines IL-1α and IL-1β. Kiniksa believes KPL-387 could expand the treatment options for recurrent pericarditis patients by enabling dosing with a single monthly SC injection in a liquid formulation.
Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our plan to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026, and that we remain on track to meeting such plan; our target profile of monthly dosing via a single subcutaneous injection in a liquid formulation for KPL-387; our belief that KPL-387 could provide a meaningful addition to therapeutic options available to patients; the design of our Phase 2/3 clinical trial of KPL-387, including the number of participants expected to enroll and our belief that the Phase 3 portion is pivotal; our beliefs about the mechanisms of our assets and potential impact of their approach; and our belief that our portfolio of assets offers the potential for differentiation.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; business development activities and their impact on our financial performance and strategy; changes in our operating plan, business development strategy or funding requirements; existing or new competition; and the impact of global economic policy, including any uncertainty in national and international markets.
These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Every Second Counts!
®
Kiniksa Investor & Media Contact
Jonathan Kirshenbaum
(781) 829-3949
jkirshenbaum@kiniksa.com
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
