Monte Rosa Therapeutics Presents Preclinical Data at ACR Convergence 2026 on the Potential of MRT-8102 in Gout

Monte Rosa expects initial Phase 2 gout data in H2 2027, following the planned Q4 2026 study start.

Rhea-AI Summary

Monte Rosa Therapeutics (GLUE) presented preclinical findings showing MRT-8102 reduced inflammatory activity in human experimental systems and a rabbit gout model. MRT-8102 degrades NEK7, a protein required to activate the NLRP3 inflammatory complex. It reduced crystal-triggered caspase-1 activity in human macrophages and suppressed release of the inflammatory protein IL-1β in stimulated blood from donors with and without gout.

In rabbits, oral MRT-8102 reduced joint swelling and improved ultrasound-assessed joint scores versus vehicle controls. It also reduced synovial-fluid C-reactive protein and induced NEK7 degradation in spleens. These are preclinical results, not outcomes in patients with gout. Monte Rosa expects its Phase 2 GEMINI-1 study to begin in Q4 2026, with initial data in H2 2027. The study will assess prevention of recurrent flares after acute flare management.

Positive

• Minor pointMRT-8102 reduced crystal-triggered caspase-1 activity in human macrophages in preclinical experiments.
• Minor pointIL-1β release was suppressed in stimulated blood samples from donors with and without gout.
• Minor pointOral MRT-8102 reduced rabbit joint swelling and improved ultrasound composite scores versus vehicle controls.
• Minor pointRabbit joint-swelling activity compared favorably with selected benchmarks, including prednisolone, colchicine and an NLRP3 inhibitor.
• Minor pointNEK7 degradation occurred in rabbit spleens, alongside reduced synovial-fluid C-reactive protein.

3 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.GEMINI-1 is expected to start in Q4 2026, with initial data expected in H2 2027.
• Minor pointPhase 1 GFORCE-1 reduced pathogenic ASCVD drivers to levels comparable to healthy volunteers in participants with obesity and elevated cardiovascular risk.
• Minor pointPhase 1 GFORCE-1 safety showed no serious adverse events and treatment-emergent adverse event rates comparable to placebo.

Negative

• None.

News Explained

Monte Rosa reports that MRT-8102 was studied in Phase 1 GFORCE-1 in people with obesity and elevated cardiovascular risk; it reduced key ASCVD-related drivers, was well tolerated, and had no serious adverse events, with treatment-emergent event rates comparable to placebo. This adds human-study experience for the drug, but not clinical results in people with gout.

Key Figures

GEMINI-1 initiation: Q4 2026 Initial GEMINI-1 data: H2 2027

GEMINI-1 initiation

Q4 2026

Expected start of the Phase 2 gout study

Initial GEMINI-1 data

H2 2027

Expected timing

Historical Context

1 past event · Latest: Nov 05

1 event

1. Nov 05

   Phase 1 results

   24h Move

   -5.3%

   MRT-8102 Phase 1 results showed 80%–90% median target-protein reduction and no serious adverse events.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

nek7, nlrp3 inflammasome, caspase-1, monosodium urate, +1 more

5 terms

nek7 medical

"MRT-8102, a NEK7-directed MGD, inhibited NLRP3 inflammasome activity"

NEK7 is a human serine/threonine kinase (NIMA-related kinase 7) that helps control cell division and also acts as a required regulatory protein for activation of the NLRP3 inflammasome, a multi-protein complex that triggers inflammatory signaling and release of certain immune cytokines. As an intracellular enzyme, NEK7 binds to and influences other proteins rather than acting as a circulating factor; its role in inflammation is distinct from but linked to its functions in mitosis.

nlrp3 inflammasome medical

"inhibited NLRP3 inflammasome activity in human experimental systems"

A protein complex inside immune cells that acts like a cellular smoke alarm: it senses stress or danger signals and triggers a rapid inflammatory response by activating enzymes that release inflammatory molecules. Investors pay attention because blocking or modulating this pathway is a major drug-development target for a range of diseases (inflammatory, cardiovascular, metabolic, neurodegenerative), so progress, trial results, safety signals, or regulatory decisions around NLRP3-targeting therapies can materially affect clinical prospects, market size, and company valuation.

caspase-1 medical

"MRT-8102 reduced caspase-1 activity in human macrophages"

Caspase-1 is an enzyme (a cysteine protease) that activates inflammatory signaling by cutting inactive precursor proteins into their active forms, most notably converting pro–interleukin-1β and pro–interleukin-18 into the mature cytokines. It is typically activated inside immune cells by multiprotein complexes called inflammasomes and can also trigger a form of inflammatory cell death called pyroptosis; its role is biochemical and regulatory, not a diagnostic label or a treatment.

monosodium urate medical

"stimulated with monosodium urate (MSU) or calcium pyrophosphate dihydrate"

The sodium salt of uric acid that can crystallize in body tissues; when uric acid levels in blood or joint fluid become high enough, monosodium urate (MSU) precipitates as microscopic needle-shaped crystals that deposit in joints and soft tissues and trigger intense inflammatory reactions associated with gout and tophus formation. MSU is distinct from dissolved uric acid—its clinical effects come from solid crystals rather than the soluble molecule—and testing or imaging is required to demonstrate crystal deposition.

ex vivo medical

"suppressed IL-1β release in ex vivo-stimulated whole blood"

Ex vivo describes tests or treatments performed on living cells, tissues, or organs that have been removed from the body and studied in an external environment. For investors, ex vivo work sits between basic lab dish tests and whole‑animal or human studies, offering a more realistic preview of how a therapy or diagnostic might behave in real tissue — like running an engine on a test stand before putting it back into a car — which can reduce scientific risk and inform development milestones.

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NEK7-directed molecular glue degrader inhibited NLRP3 inflammasome activation in human experimental systems and demonstrated anti-inflammatory activity in a rabbit model of gouty arthritis

GEMINI-1, a Phase 2 study of MRT-8102 in patients with gout, is expected to initiate in Q4 2026, with initial data expected in H2 2027

Poster presentation on November 9, 2026, at 10:30 a.m. ET

BOSTON, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced the presentation of preclinical data showing that MRT-8102, a NEK7-directed MGD, inhibited NLRP3 inflammasome activity in human experimental systems and reduced inflammation in a rabbit model of gouty arthritis, supporting the Company’s planned Phase 2 study in patients with gout. The data are being presented at ACR Convergence 2026, being held November 6-11 in Orlando, FL.

“MRT-8102 offers a novel approach to addressing NEK7/NLRP3-driven inflammation in gout by selectively degrading NEK7, a critical component of the inflammasome,” said Sharon Townson, Ph.D., Chief Scientific Officer of Monte Rosa Therapeutics. “Oral MRT-8102 reduced joint swelling and improved ultrasound-assessed joint pathology in a preclinical model of gouty arthritis. We believe these findings, together with inhibition of crystal-induced inflammasome activation in human macrophages and suppression of IL-1β release in blood samples from donors with gout, support the potential of MRT-8102 as a new therapeutic option for gout and provide a strong rationale for clinical evaluation in patients with recurrent flares.”

The poster, entitled “MRT-8102, an Orally Bioavailable NEK7-Selective Molecular Glue Degrader, Suppresses NLRP3 Inflammasome Activation and Demonstrates Efficacy in a Rabbit Model of Gouty Arthritis” (Poster #1082), will be presented by Philippe Pagni, Ph.D., Director of Biology, Monte Rosa Therapeutics, during Poster Session B, “Innate Immunity,” on Monday, November 9, from 10:30 a.m. to 12:30 p.m. ET.

Summary of preclinical study results:

• MRT-8102 reduced caspase-1 activity in human macrophages stimulated with monosodium urate (MSU) or calcium pyrophosphate dihydrate (CPPD) crystals, supporting its potential to address crystal-induced inflammation in gout and pseudogout.
• MRT-8102 suppressed IL-1β release in ex vivo-stimulated whole blood from donors with and without gout.
• In an MSU-induced rabbit model of gouty arthritis, oral administration of MRT-8102 reduced joint swelling and improved musculoskeletal ultrasound composite scores relative to vehicle controls.
• In the rabbit model, MRT-8102 reduced joint swelling with activity that compared favorably to selected clinical and mechanistic benchmarks, including prednisolone, colchicine, and an NLRP3 inhibitor.
• MRT-8102 induced NEK7 degradation in rabbit spleens and reduced synovial-fluid C-reactive protein, consistent with target engagement and suppression of NLRP3-associated inflammation.
  
  

GEMINI-1, a Phase 2 study of MRT-8102 in patients with gout, is expected to initiate in Q4 2026. The study will evaluate prevention of flare recurrence following acute flare management, with initial data expected in H2 2027.

About MRT-8102
MRT-8102 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that targets NEK7, a protein required for NLRP3 inflammasome assembly and activation. The NEK7/NLRP3 pathway is implicated in numerous inflammatory diseases, including atherosclerotic cardiovascular disease (ASCVD), gout, and hidradenitis suppurativa. In ASCVD, the NEK7/NLRP3 pathway drives multiple processes relevant to plaque formation and growth, vessel wall alterations, and thrombosis. In gout, MSU crystals trigger NEK7-mediated NLRP3 complex assembly, driving release of IL-1β and damage-associated molecular patterns (DAMPs) and inducing flare pathology. By degrading NEK7, MRT-8102 is designed to inhibit NLRP3 inflammasome activation and downstream inflammatory signaling, including the release of IL-1β and DAMPs that contribute to tissue inflammation and damage. In the Phase 1 GFORCE-1 study involving participants with obesity and elevated cardiovascular risk, MRT-8102 reduced key pathogenic drivers of ASCVD to levels comparable to healthy volunteers. MRT-8102 was well tolerated, with no serious adverse events reported and treatment-emergent adverse event rates comparable to placebo.

About Monte Rosa
Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of first-in-class and only-in-class MGDs, spanning autoimmune and inflammatory diseases, oncology, and beyond, with three programs in the clinic. Monte Rosa has ongoing collaborations with leading pharmaceutical companies in the areas of immunology, oncology and neurology. For more information, visit www.monterosatx.com.

Investors
Andrew Funderburk
ir@monterosatx.com

Media
Cory Tromblee, Scient PR
media@monterosatx.com

Forward-Looking Statements
This communication includes express and implied “forward-looking statements,” including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained herein include, but are not limited to, statements about the ongoing development of our NEK7-directed MGD, referred to as MRT-8102, including statements regarding the potential for MRT-8102 to address NEK7/NLRP3-driven inflammation and serve as a potential new, differentiated therapeutic option in gout, including in gout flare prophylaxis, our rationale for further clinical evaluation of MRT-8102, our expectations to initiate multiple Phase 2 studies of MRT-8102, including the GEMINI-1 study in gout patients in Q4 2026 with initial data expected in H2 2027, and our expectations for our initial clinical data, among others. By their nature, these statements are subject to numerous risks and uncertainties, including those risks and uncertainties set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission on March 17, 2026, and any subsequent filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements, as well as the risk that outcomes of preclinical studies may not be predictive of clinical trial results and the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance, or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations, or otherwise, except as required by applicable law. Certain information contained in these materials and any statements made orally during any presentation of these materials that relate to the materials or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of these materials, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in these materials relating to or based on such internal estimates and research.

FAQ

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What did Monte Rosa's MRT-8102 preclinical gout studies show?

MRT-8102 reduced inflammatory activity in human experimental systems and a rabbit model of gouty arthritis. It suppressed crystal-triggered caspase-1 activity in human macrophages and IL-1β release in stimulated blood samples. In rabbits, oral treatment reduced joint swelling and improved ultrasound composite scores relative to vehicle controls.

When will Monte Rosa start the GEMINI-1 Phase 2 gout study?

Monte Rosa expects GEMINI-1 to begin in Q4 2026, with initial data expected in H2 2027. The Phase 2 study will evaluate prevention of flare recurrence in patients with gout following acute flare management.