~70% IgA reductions sustained at 12 weeks after a single dose of JADE101
>70% IgA reductions projected at steady state with a single subcutaneous maintenance injection every 12 weeks
IgA-lowering effect observed to be faster, deeper, and more durable than with first-generation anti-APRIL or dual APRIL/BAFF agents
JADE101 was well-tolerated across all evaluated doses
Phase 2 clinical trial in patients with IgA nephropathy underway, with interim clinical data expected in 2027
Phase 3 registrational trial expected to be initiated in the first half of 2027
Company to host a webcast and conference call today at 8:00 a.m. ET

SAN FRANCISCO and VANCOUVER, British Columbia, June 01, 2026 (GLOBE NEWSWIRE) -- Jade Biosciences, Inc. (the "Company" or "Jade") (NASDAQ:JBIO), a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today announced positive interim results from its Phase 1 trial evaluating JADE101, a novel, investigational anti-A Proliferation-Inducing Ligand (APRIL) monoclonal antibody in development for the treatment of immunoglobulin A nephropathy (IgAN). JADE101 is designed with ultra-high binding affinity to selectively block APRIL, a key driver of pathogenic IgA production in IgAN, a chronic autoimmune disease that frequently affects young adults and can lead to end-stage kidney disease over a patient's lifetime. These results will be presented in a focused oral session during the 63rd European Renal Association (ERA) Congress, taking place in Glasgow, Scotland, from June 3-6, 2026.

"IgA is a critical biomarker in IgA nephropathy, with strong evidence linking early and sustained IgA reductions to later reductions in proteinuria, a key marker of disease activity and long-term kidney risk," said Jonathan Barratt, PhD, Mayer Professor of Renal Medicine at the University of Leicester. "With JADE101, IgA reductions of approximately 70% sustained at 12 weeks in healthy volunteers are both biologically and clinically meaningful, offering the potential to deliver more substantial clinical outcomes and extend the dosing interval beyond currently available therapies. JADE101's potential to deliver sustained disease control with less frequent dosing could represent a significant advance in treating a disease that often begins in young adulthood and requires lifelong management."

"The interim results from this Phase 1 trial showed that JADE101 drove rapid, deep and durable IgA reductions in healthy volunteers, with favorable tolerability and the potential for dosing every 12 weeks," said Tom Frohlich, Chief Executive Officer of Jade Biosciences. "JADE101 was designed with ultra-high potency, selective APRIL inhibition and extended half-life to achieve a differentiated and patient-friendly profile. These data position JADE101 as a potentially best-in-class anti-APRIL therapy at the forefront in a large and growing market. With the goal of bringing this therapy to patients as quickly as possible, we have advanced JADE101 into a Phase 2 trial and plan to initiate a Phase 3 registrational trial in the first half of 2027."

JADE101 Phase 1 Trial Design

The JADE101 Phase 1 trial is a double-blind, placebo-controlled study evaluating the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single ascending subcutaneously administered doses of JADE101 in healthy volunteers.

As of the data cutoff of April 14, 2026, the trial has enrolled 32 healthy adult volunteers across four dose cohorts, with eight participants per cohort randomized in a 6:2 ratio to receive JADE101 or placebo. Evaluated doses included single subcutaneous administrations of 175 mg, 350 mg, 700 mg, and 1,400 mg.

Key findings at this interim analysis included:

Depth and Duration of IgA Reductions Driven by Potent Free APRIL (fAPRIL) Suppression

Mean IgA reductions reached approximately 70% from baseline and were sustained at 12 weeks at the 700 mg dose; this dose is anticipated to reflect the steady-state IgA responses in IgAN patients with the planned JADE101 dosing strategy
- IgA-lowering effect observed to be deeper, faster, and more durable following a single dose of JADE101 than with first-generation anti-APRIL or dual APRIL/BAFF inhibitors
- Greater than 70% IgA reductions simulated at steady-state with a single subcutaneous injection of 350 mg of JADE101 every 12 weeks (Q12W) following one 700 mg induction dose, which could support best-in-class clinical activity with a convenient dosing regimen of only four injections per year
- IgA-lowering potency estimated to be approximately 379-fold higher than sibeprenlimab and approximately 26-fold higher than povetacicept
JADE101 achieved rapid, complete and durable suppression of fAPRIL, consistent with the femtomolar APRIL binding affinity of JADE101

Favorable Safety Profile; Well-Tolerated Across All Evaluated Subcutaneous Dose Levels

Single subcutaneous doses of JADE101 up to 1,400 mg were well tolerated with an observed safety profile generally consistent with the anti-APRIL class
The most common treatment-emergent adverse events in the pooled safety analysis occurring in more than two participants were headache, upper respiratory tract infection, injection site erythema, oropharyngeal pain and pyrexia
There were no serious adverse events and no adverse events leading to study discontinuation
There were no cases of hypogammaglobulinemia, defined as IgG less than or equal to 3 g/L

Differentiated Pharmacokinetic Profile Supports Potential for Convenient Dosing

JADE101 demonstrated dose-dependent increases in exposure across evaluated dose levels
Half-life at steady state for JADE101 was approximately 8.7-fold longer than reported for povetacicept and approximately 2.6-fold longer than reported for sibeprenlimab
Target-mediated drug disposition threshold with JADE101 is estimated to be approximately 2.5-fold lower than reported for sibeprenlimab
No apparent impact of anti-drug antibodies on PK or PD was observed

Phase 2 IgAN Trial Underway with Phase 3 Registrational Trial Planned for First Half of 2027

JUNIPER is an ongoing Phase 2 clinical trial evaluating JADE101 in participants with IgAN. The open-label trial is expected to enroll approximately 30 participants. Participants are expected to receive a 700 mg induction dose of JADE101 at treatment onset followed by maintenance doses of 350 mg starting at Week 4 and subsequently either every 8 weeks (n=15) or every 12 weeks (n=15). Evaluating both dose intervals is intended to support accelerated Phase 3 initiation and satisfy global regulatory expectations for dose finding. The primary objectives of the trial are to evaluate the safety and tolerability of JADE101. Secondary and exploratory objectives include changes in 24-hour urine protein-to-creatinine ratio (UPCR-24), including the proportion of participants achieving UPCR-24 levels below 0.5 g/day and 0.3 g/day, renal function as measured by estimated glomerular filtration rate (eGFR), and hematuria resolution over time. Interim clinical data are anticipated in 2027.

Jade plans to initiate a registrational Phase 3 clinical trial in the first half of 2027, pending Food and Drug Administration requirements.

Conference Call and Webcast

Jade Biosciences will host a conference call and webcast on Monday, June 1, 2026, at 8:00 a.m. ET to discuss the JADE101 interim clinical data.

Investors and the general public are invited to listen to the live webcast and may register on the "Events and Presentations" page of Jade's website at JadeBiosciences.com. To join the live conference call, participants must register here. Upon registering, participants will receive dial-in details and a unique PIN to access the call. A replay of the webcast will be available on the Jade website shortly after the call concludes.

Jade's ERA 2026 session details are as follows:

Presentation Title: Interim Results of a Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JADE101 in Healthy Volunteers

Presenter: Brandon Gufford, PharmD, PhD, DABCP, Jade Biosciences

Session: Glomerular and Tubulo-interstitial Diseases

Date/Time: Friday, June 5, 2026, 2:51 – 2:57 PM BST / 9:51 - 9:57 AM ET

Presentation Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of JADE101 in Participants with Immunoglobulin A Nephropathy

Presenter: Li Li, MD, Jade Biosciences

Session: Glomerular and Tubulo-interstitial Diseases

Date/Time: Thursday, June 4, 2026, 5:45 to 5:51 PM BST / 12:45 - 12:51 ET

About IgA nephropathy (IgAN)

IgAN is a chronic autoimmune kidney disease that affects approximately 169,000 people in the U.S. and is most often diagnosed in young adults. The disease is characterized by the deposition of pathogenic IgA-containing immune complexes in the kidneys. These deposits can lead to increased protein in the urine, also known as proteinuria, declining kidney function, and potentially end-stage kidney disease requiring dialysis or a transplant. IgAN often requires lifelong treatment to preserve kidney function and prevent progression to kidney failure.

About Jade Biosciences, Inc.  

  

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated for the treatment of immunoglobulin A nephropathy. Jade's pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody program. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.  

  

Forward-Looking Statements and Cross-Study Comparisons

Certain statements in this communication, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Jade's expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation: Jade's ability to achieve the expected benefits or opportunities with respect to JADE101, including its best-in-class potential; the expected enrollment of the Phase 2 clinical trial of JADE101; the expected timelines for the availability of interim data from the Phase 2 clinical trial of JADE101; Jade's plans to conduct a Phase 3 clinical trial of JADE101, the design and timing thereof and Jade's expectations that such trial will serve as a registrational study; Jade's proposed dosing strategy and its expected optimization of clinical activity and convenience; projected or simulated pharmacodynamic outcomes, including steady-state IgA reductions, and the potential therapeutic uses, efficacy, durability, safety profiles, and dosing of JADE101. The words "opportunity," "potential," "milestones," "pipeline," "can," "goal," "strategy," "target," "anticipate," "achieve," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "plan," "possible," "project," "should," "will," "would" and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Jade will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Jade's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: interim results of a clinical trial are not necessarily indicative of final results and one or more of the outcomes may materially change following more comprehensive reviews of the data, as follow-up on the outcome of any particular participant continues and as more participant or final data becomes available; modeled and predicted data for JADE101 may not be realized in actual clinical studies and may not accurately represent performance of third party products; the ongoing and planned clinical trials of JADE101 and any other clinical trials may be delayed or may not demonstrate desirable efficacy or predicted performance; Jade's planned JADE101 Phase 3 clinical trial may be delayed based on FDA feedback or requirements, as the FDA retains broad discretion to require additional clinical data for any product candidate prior to the conduct of a Phase 3 clinical trial or submission for regulatory approval; even if such Phase 3 trial is successful, it may not support regulatory approval; adverse events and safety signals may occur; Jade may experience unanticipated costs, difficulties or delays in the product development process; Jade's product candidates may be delayed to a point where they are not commercially viable; clinical trial start up, enrollment or regulatory challenges may occur; challenges associated with Jade's dependence on third-party vendors for the development, manufacture and supply of its product candidates may occur; Jade may use its capital resources sooner than expected; and the other risks, uncertainties and factors more fully described in Jade's most recent filings with the Securities and Exchange Commission (including the Quarterly Report on Form 10-Q for the quarter ended March 31, 2026). Should one or more of these risks or uncertainties materialize, or should any of Jade's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You should not place undue reliance on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Jade does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Jade. No head-to-head study has been conducted comparing JADE101 to other candidates or approved agents. Differences exist between study designs, patient characteristics and other factors, and caution should be exercised in drawing any conclusions from a comparison of the data across studies as cross-study comparisons are inherently limited and such data may not be directly comparable. In addition, data from third party products have been extracted via digitization and represent approximate values.

 

Jade Biosciences Contact  

 

Priyanka Shah  

Media@JadeBiosciences.com  

IR@JadeBiosciences.com  

908-447-6134  

  

Jade Biosciences Announces Positive Interim Phase 1 Results for JADE101 Demonstrating Potential Best-in-Class Profile and Every-12-Week Dosing in IgA Nephropathy