Full Press Release Details
Kiniksa Pharmaceuticals
Announces Development Indication for Abiprubart
Phase 2b trial in Sjogren's Disease planned to initiate in 2H 2024 -
Phase 2 Cohort 4 rheumatoid arthritis data further validate biological activity -
development in Sjogren's Disease fully funded through Phase 3 -
expects to remain cash flow positive on an annual basis within current operating plan -
- April 2, 2024 - Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical
company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced
plans to initiate a Phase 2b trial with abiprubart in Sjogren's Disease. Additionally, the company announced data from Cohort 4
of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis. Abiprubart is an investigational humanized anti-CD40 monoclonal
antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.
"We believe abiprubart has the potential to provide meaningful
benefit to patients suffering from Sjogren's Disease, a debilitating disorder with no current FDA-approved therapies. Based on the
clear biological activity demonstrated by abiprubart, potential for convenient subcutaneous administration, and external proof-of-concept
of inhibition of the CD40-CD154 interaction, we plan to initiate a Phase 2b trial of abiprubart in Sjogren's Disease in the second
half of 2024," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Supported by our robust ARCALYST revenue
growth and current cash position, we continue to execute a strategic and disciplined capital allocation approach in areas we believe provide
the best opportunity to drive long-term value. Based on our current operating plan, which includes advancement of abiprubart through
Phase 3 development in Sjogren's Disease, we expect to remain cash flow positive on an annual basis."
Phase 2b Clinical Trial of Abiprubart in Sjogren's Disease
Kiniksa is planning to initiate a randomized,
double-blind, placebo-controlled Phase 2b trial designed to evaluate the treatment response
of chronic subcutaneous (SC) administration of abiprubart in patients with Sjogren's
The placebo-controlled portion of the trial will randomize approximately
201 patients in a 1:1:1 ratio to receive abiprubart 400 mg SC biweekly, 400 mg SC monthly, or placebo over a period of 24 weeks. The primary
endpoint will be change from baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) versus placebo at Week
24. Subsequently, patients will enter a long-term extension in which all patients will receive active treatment for an additional 24 weeks.
The trial is expected to initiate in the second half of 2024.
Abiprubart Phase 2 Rheumatoid Arthritis Data
The Phase 2 rheumatoid arthritis trial uses a randomized, double-blind,
placebo-controlled design to evaluate pharmacokinetics (PK), safety, and efficacy of chronic SC administration of abiprubart and to provide
optionality to evaluate abiprubart across a range of autoimmune diseases. The trial enrolled patients with active rheumatoid arthritis
who had an inadequate response or were intolerant to a Janus kinase inhibitor (JAKi) or at least one biologic disease-modifying anti-rheumatic
Following previously reported topline data, Kiniksa today announced
final data from the first three cohorts of the clinical trial:
Today, Kiniksa announced topline data from the fourth cohort of the
Additionally, Kiniksa today announced a post-hoc analysis of data pooled
from the Cohort 3 and Cohort 4 abiprubart and placebo groups:
"These Phase 2 data demonstrate that abiprubart is a potentially
efficacious and well-tolerated therapeutic approach for multiple autoimmune diseases, including Sjogren's Disease," said John
F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. "The comparable magnitude of reduction in Rheumatoid Factor observed across
weekly, biweekly, and monthly dosing and supportive post-hoc analysis of pooled efficacy data reinforce our confidence that abiprubart
is highly active. We look forward to initiating the Phase 2b trial in Sjogren's Disease in the second half of this year."
Kiniksa expects to remain cash flow positive on an annual basis within
its current operating plan, which includes advancement of abiprubart through Phase 3 development in Sjogren's Disease.
Kiniksa is a commercial-stage biopharmaceutical company focused on
discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant
unmet medical need. Kiniksa's immune-modulating assets, ARCALYST, abiprubart, and mavrilimumab, are based on strong biologic rationale
or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation.
For more information, please visit www.kiniksa.com.
Abiprubart is an investigational
humanized monoclonal antibody that binds to CD40 and is designed to inhibit the CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory
signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the
CD40-CD154 co-stimulatory interaction is an attractive approach to addressing multiple autoimmune disease pathologies.
About the Phase 2 Clinical
Trial of Abiprubart in Rheumatoid Arthritis
The ongoing Phase 2 rheumatoid
arthritis trial uses a randomized, double-blind, placebo-controlled design to evaluate PK, safety, and efficacy of chronic SC administration
of abiprubart and to provide optionality to evaluate abiprubart across a range of autoimmune diseases. This trial enrolled patients with
active rheumatoid arthritis who had an inadequate response or were intolerant to a JAKi or at least one bDMARD.
The multiple ascending-dose PK
lead-in portion randomized 8 patients each in a 3:1 ratio to receive abiprubart 2 mg/kg or placebo (Cohort 1) or 5 mg/kg or placebo (Cohort
2), administered subcutaneously biweekly over a period of 12 weeks. The primary objective of this part of the trial was to evaluate PK,
safety, and tolerability over 12 weeks. The secondary efficacy endpoint was change from baseline in DAS28-CRP versus placebo.
The first part of the proof-of-concept
portion of the trial (Cohort 3) randomized 78 patients in a 1:1:1 ratio to receive abiprubart 5 mg/kg SC weekly, abiprubart 5 mg/kg SC
biweekly, or placebo over a period of 12 weeks. The final part of the proof-of-concept portion of the trial (Cohort 4) randomized
51 patients in a 3:2 ratio to receive a fixed 600 mg loading dose on Day 1 followed by 400 mg SC every four weeks or placebo over a period
of 12 weeks. The primary efficacy endpoint of the proof-of-concept portion of the trial was change from baseline in DAS28-CRP versus placebo.
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
2b clinical trial of abiprubart in Sjogren's Disease in the second half of 2024; our expectation that abiprubart development in
Sjogren's Disease will remain fully funded through Phase 3 development; our expectation to advance abiprubart through Phase 3 development
in Sjogren's Disease; our expectation to remain cash flow positive on an annual basis within our current operating plan; our expectation
that our capital allocation will provide the best opportunity to drive long-term value; our expectations around the possibility of achieving
meaningful effect and differentiation via subcutaneous administration with abiprubart; future clinical trial design, including the design
of our planned Phase 2b trial of abiprubart in Sjogren's Disease; our beliefs about the mechanisms of our product candidates and
potential impact of their approach, including that using abiprubart to disrupt the CD40-CD154 co-stimulatory interaction is an attractive
approach to address multiple autoimmune disease pathologies; and our belief that all of our product candidates offer the potential for
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 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; changes in our operating plan, business development strategy or funding requirements; and existing or new competition.
These and other important factors discussed in our filings with the