Monte Rosa Therapeutics Announces Positive Interim Phase 1 Data of MRT-8102 Demonstrating Profound CRP Reductions in Elevated CVD-risk Subjects

Rhea-AI Summary

Monte Rosa Therapeutics (NASDAQ: GLUE) announced positive interim Phase 1 data for MRT-8102, a NEK7-directed oral molecular glue degrader targeting NLRP3/IL-1/IL-6 inflammation pathways. In Part 3 (24 subjects dosed for 4 weeks as of Dec 23, 2025) median hsCRP fell 85% and 94% of subjects reached hsCRP <2 mg/L from a median baseline of 6.3 mg/L. NEK7 degradation in peripheral T cells was ~80–90% across doses (5–400 mg). Median plasma IL-6 dropped 55%; two subjects had a 75% CSF IL-6 decrease. Safety was described as favorable with mainly mild–moderate AEs and no evidence of increased infection risk. Readout of the expanded study is anticipated in H2 2026, and a Phase 2 ASCVD study is planned for 2026.

Positive

• hsCRP -85% after 4 weeks in Part 3 (median baseline 6.3 mg/L)
• 94% of subjects achieved hsCRP <2 mg/L after 4 weeks
• NEK7 degradation ~80–90% in peripheral T cells across doses
• IL-6 median -55% in high CRP subjects across dose levels
• CSF IL-6 -75% observed in two subjects with elevated CSF IL-6

Negative

• Interim efficacy data based on only 24 subjects in Part 3 as of data cutoff
• NEK7 degradation appeared approximately equivalent across 5–400 mg, limiting dose differentiation

Key Figures

hsCRP reduction 85% After four weeks of MRT-8102 dosing in elevated CVD-risk subjects

Subjects below 2 mg/L hsCRP 94% Proportion achieving hsCRP <2 mg/L after four weeks

Baseline hsCRP 6.3 mg/L Median baseline level in elevated CVD-risk subjects

Dose range 5 mg to 400 mg SAD and MAD cohorts dose levels for MRT-8102

NEK7 degradation 80–90% Degradation in peripheral blood T cells across cohorts

IL-6 reduction 55% Median endogenous IL-6 drop in high-CRP subjects

CSF IL-6 decrease 75% Decrease in CSF IL-6 in two subjects with elevated baseline

Part 3 subjects dosed 24 subjects Completed four weeks of dosing as of Dec 23, 2025

Market Reality Check

$23.23 Last Close

Volume Volume 1,610,191 is 1.35x the 20-day average of 1,194,174. normal

Technical Price 16.01 is trading above the 200-day MA at 7.81.

Peers on Argus

Key biotech peers showed mixed moves (e.g., DRTS +9.98%, CTNM -5.29%, ENGN -4.73%), indicating GLUE’s positive setup is stock-specific rather than a broad sector rotation.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Jan 06	Clinical data preview	Positive	+11.2%	Announcement of upcoming interim MRT-8102 Phase 1 data presentation.
Dec 16	Oncology interim data	Positive	+13.4%	Interim MRT-2359 plus enzalutamide data in heavily pretreated mCRPC.
Dec 15	Clinical update notice	Positive	+0.9%	Notice of upcoming MRT-2359 Phase 1/2 interim data presentation.
Nov 06	Earnings and deal	Positive	+5.7%	Q3 2025 results and major Novartis collaboration with substantial upfront payment.
Nov 03	Investor conferences	Positive	-6.1%	Participation in multiple investor conferences without new clinical data.

Pattern Detected

Clinical and partnership-related news for GLUE has often coincided with positive price reactions, with occasional divergences on less fundamental events like conference participation.

Recent Company History

Over the last year, Monte Rosa has steadily advanced its molecular glue degrader pipeline across oncology and inflammation. Key clinical milestones include initiation of the Phase 1 MRT-8102 study in high CVD-risk subjects (Jul 21, 2025) and multiple clinical updates for MRT-2359 in mCRPC. Strategic momentum was reinforced by Q3 2025 results and a major Novartis collaboration reported on Nov 6, 2025. The Jan 7, 2026 MRT-8102 interim data follow yesterday’s event announcement, fitting into a pattern of pipeline execution supported by strong partners and prior positive data readouts.

Market Pulse Summary

The stock surged +45.4% in the session following this news. A strong positive reaction aligns with prior patterns where GLUE often moved on clinical milestones, such as the 11.18% move on the MRT-8102 event preview and other trial updates. The depth of hsCRP and IL-6 reductions supports the mechanistic story across inflammatory indications. However, historical data also show occasional divergences on non-data news, and investors have to weigh execution risks, longer timelines to the planned Phase 2 readouts, and general biotech volatility when assessing durability.

Key Terms

molecular glue degrader medical

"a NEK7-directed molecular glue degrader in development for the treatment"

A molecular glue degrader is a small drug-like molecule that acts like a tiny adhesive, sticking a specific disease-related protein to the cell’s natural disposal machinery so the protein is destroyed rather than merely blocked. Investors watch these compounds because they can turn previously untreatable targets into removable liabilities, potentially creating breakthrough therapies, shifting development risk, and offering strong commercial upside if clinical results and regulatory approval follow.

NLRP3 inflammasome medical

"for the treatment of inflammatory conditions driven by the NLRP3 inflammasome, IL-1, and IL-6"

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.

high-sensitivity CRP medical

"after 4 weeks of dosing MRT-8102 decreased median high-sensitivity CRP (hsCRP) levels"

A high-sensitivity CRP (hs-CRP) test measures very low levels of C-reactive protein in the blood, a protein that rises when the body has inflammation. Investors care because small changes in hs-CRP can signal higher risk for heart disease and are often used to judge the effectiveness of drugs, diagnostics, or preventive treatments—like a thermostat showing subtle changes in a home’s heating that hint at a larger problem or improvement.

single ascending dose medical

"Single ascending dose (SAD) and multiple ascending dose (MAD) cohorts demonstrated"

A single ascending dose is a method used in testing new medicines where small amounts are given to participants, gradually increasing each time to find the safest and most effective dose. For investors, it provides important information about a drug’s safety and potential, helping gauge the progress and prospects of a pharmaceutical development.

multiple ascending dose medical

"Single ascending dose (SAD) and multiple ascending dose (MAD) cohorts demonstrated"

A multiple ascending dose is a method used in testing new medicines where small groups of people receive gradually larger amounts of the drug over time. This approach helps researchers find the safest and most effective dose without causing too many side effects. For investors, it signals ongoing steps in drug development that can impact a company's potential success or approval prospects.

pharmacokinetics medical

"designed to evaluate safety and tolerability, pharmacokinetics (PK), and pharmacodynamics"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pharmacodynamics medical

"evaluate safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)"

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

cerebrospinal fluid medical

"In two subjects with elevated basal levels of cerebrospinal fluid (CSF) IL-6, a significant decrease"

A clear fluid that surrounds and cushions the brain and spinal cord, acting like a protective bath and cleanup system that removes waste and helps circulate nutrients. For investors, cerebrospinal fluid matters because it is a common source of diagnostic markers and a route for delivering or testing neurological drugs; changes in its composition can signal disease or affect a therapy’s development, approval prospects, and market value.

AI-generated analysis. Not financial advice.

In subjects with elevated cardiovascular disease (CVD) risk, MRT-8102, a NEK7-directed molecular glue degrader in development for the treatment of NLRP3/IL-1/IL-6 driven inflammatory diseases, demonstrated rapid and durable reductions in systemic inflammation 

After four weeks of MRT-8102 treatment, C-reactive protein (CRP) levels were reduced by 85%, and 94% of study participants achieved CRP values below 2 mg/L, a threshold associated with reduced cardiovascular disease (CVD) risk

Single ascending dose (SAD) and multiple ascending dose (MAD) cohorts demonstrated deep and sustained NEK7 degradation at doses from 5 mg to 400 mg

Favorable safety profile observed with mild to moderate adverse events (AEs) and no evidence of increased infection risk

Ongoing GFORCE-1 Study of MRT-8102 in subjects with elevated CVD risk expanded to multiple dose levels to accelerate development in atherosclerotic cardiovascular disease (ASCVD); anticipated readout in H2 2026

Plan to initiate Phase 2 ASCVD study in 2026; additional indications being evaluated

Conference call and webcast planned for today at 8 a.m. ET

BOSTON, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced positive interim data from an ongoing Phase 1 clinical study evaluating MRT-8102, a NEK7-directed MGD being developed for the treatment of inflammatory conditions driven by the NLRP3 inflammasome, IL-1, and IL-6.

“Today we showcased the potential of MRT-8102, an orally bioavailable molecular glue degrader of NEK7, to transform the treatment of ASCVD and other cardiovascular and cardiometabolic diseases. In this interim data readout, after 4 weeks of dosing MRT-8102 decreased median high-sensitivity CRP (hsCRP) levels by 85% and resulted in suppression of hsCRP to <2 mg/L in 94% of subjects, despite a significantly higher median baseline level of 6.3 mg/L as compared to benchmark clinical trials. These remarkable interim data from our ongoing Phase 1 study of MRT-8102 demonstrate for the first time that treatment with an oral molecular glue degrader of NEK7 led to levels of CRP reduction comparable to those previously reported with biologic therapies,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “During both the SAD and MAD portions of the study, with doses ranging from 5 to 400 mg daily, we observed substantial and approximately equivalent degradation of NEK7 across all dose levels, as well as corresponding reductions in IL-1β and IL-6, along with a favorable safety profile. Importantly, we saw substantial decreases in CRP levels across all dose levels that were nearly equivalent to those achieved in Part 3 of the trial, suggesting maximum activity from the lowest dose level and pointing to a broad safe dosing range available for further development. We believe our data support the potential of MRT-8102 to be an oral best-in-class therapeutic among agents targeting the NLRP3/IL-1/IL-6 pathway and establish the significant potential opportunity for MRT-8102 in multiple chronic inflammatory diseases, including ASCVD.”

Filip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa Therapeutics, commented, “Based on the highly encouraging data for MRT-8102 we have observed so far, we are expanding our proof-of-concept GFORCE-1 study in subjects with elevated CVD risk, in order to accelerate the anticipated Phase 2 (GFORCE-2) study of MRT-8102 in ASCVD. We expect results from the GFORCE-1 study in H2 2026. Moreover, we are evaluating additional Phase 2 proof-of-concept studies in metabolic dysfunction-associated steatohepatitis (MASH), gout, and recurrent pericarditis, conditions strongly linked to NLRP3 pathway activation.”

The MRT-8102 Phase 1 study (clinicaltrials.gov identifier NCT07119125) is a randomized, double-blind, placebo-controlled trial in healthy volunteers that includes both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The study is designed to evaluate safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), including NEK7 degradation and ex vivo responses to inflammasome stimulation. Part 3 of the Phase 1 study is a randomized, placebo-controlled trial enrolling subjects with increased CVD risk due to obesity and elevated CRP, designed to evaluate safety and tolerability, changes in CRP levels, pharmacokinetics, and changes in other inflammatory markers.

Summary of Key Interim Study Results

• SAD cohorts enrolled 48 subjects and MAD cohorts enrolled 40 subjects. In the Part 3 cohort, 24 subjects have completed 4 weeks of dosing.
• Rapid, deep and sustained degradation of NEK7 was observed in peripheral blood T cells (~80 to 90%) in the SAD, MAD, and Part 3 cohorts across all dose levels.
• MRT-8102 led to significant reductions in serum hsCRP across all dose levels following single dose drug administration and 7-day multiple dose drug administration.
• In the MAD cohorts, MRT-8102 led to marked suppression of IL-1β secretion in patients with elevated CRP levels at baseline.
• When analyzing high CRP subjects across all dose levels, significant reductions of endogenous IL-6 were observed, with median IL-6 levels dropping by 55%, to levels below the cardiovascular risk threshold.
• In two subjects with elevated basal levels of cerebrospinal fluid (CSF) IL-6, a significant decrease of 75% in CSF IL-6 was noted; plasma IL-6 levels at baseline for these two subjects was low, potentially suggesting central nervous system /CSF-specific effects of MRT-8102.
• In Part 3 of the study in subjects with elevated CVD risk, in 24 subjects dosed for 4 weeks as of the data cutoff of December 23, 2025, MRT-8102 resulted in a decrease of hsCRP of 85% after four weeks of dosing, compared with no significant change in hsCRP for the placebo group. In addition, 94% of subjects showed suppression of hsCRP to <2mg/L after four weeks of dosing (median baseline level was 6.3 mg/L).
• The MRT-8102 safety profile observed to date was favorable. Based on blinded safety data for MRT-8102 and placebo, as of the data cutoff, AEs were limited in number, mild to moderate, and self-resolving. There was no dose-dependent relationship in frequency or severity of AEs observed and no evidence of increased infection risk.

ANTICIPATED UPCOMING CORPORATE MILESTONES AND DEVELOPMENT PRIORITIES
Immunology and Inflammation disease programs

• Share data from the GFORCE-1 study of MRT-8102 in subjects with elevated CVD risk in H2 2026.
• Initiate Phase 2 GFORCE-2 study of MRT-8102 in ASCVD in 2026.
• Monte Rosa expects its collaborator, Novartis, to initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026.
• Submit an IND application for a next-generation NEK7-directed MGD in 2026.

Oncology programs

• Initiate MODeFIRe-1 Phase 2 study of MRT-2359 in combination with a second-generation androgen receptor inhibitor in castration-resistant prostate cancer (CRPC) in 2026.
• Present updated data from the ongoing Phase 1/2 study of MRT-2359 at the ASCO Genitourinary Cancers Symposium in February 2026.
• Submit an IND application for a CDK2 and/or cyclin E1-directed MGD in 2026.
  

Investor Conference Call
Monte Rosa will host a conference call and webcast presentation today, January 7, 2026, at 8:00 a.m. ET. A webcast of the presentation will be accessible via the “Events & Presentations” section of Monte Rosa’s website at ir.monterosatx.com. Registration for the conference call is available at the following link. An archived version of the webcast will be made available for 30 days following the presentation.

About MRT-8102
MRT-8102 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that targets NEK7 for the treatment of inflammatory diseases linked to NLRP3, IL-1, and IL-6 dysregulation. NEK7 has been shown to be required for NLRP3 inflammasome assembly, activation and IL-1β release both in vitro and in vivo. Aberrant NLRP3 inflammasome activation and the subsequent release of active IL-1β and interleukin-18 (IL-18) has been implicated in multiple inflammatory disorders, including cardiovascular disease, gout, osteoarthritis, asthma, neurodegenerative diseases, and metabolic disorders. In a non-human primate model, MRT-8102 was shown to potently, selectively, and durably degrade NEK7, and resulted in near-complete reductions of IL-1β and caspase-1 following ex vivo stimulation of whole blood. MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology studies. MRT-8102 is currently being investigated in a Phase 1 study (clinicaltrials.gov identifier NCT07119125) in healthy participants and participants at elevated cardiovascular disease risk. In an interim analysis from the Phase 1 study, in subjects with elevated cardiovascular disease (CVD) risk, MRT-8102 demonstrated rapid and durable reductions in systemic inflammation, including reduction of CRP levels by 85% after four weeks of treatment.

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.

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 our ability to grow our product pipeline, our ability to successfully complete research and further development and commercialization of our drug candidates in current or future indications, including the timing and results of our clinical trials and our ability to conduct and complete clinical trials, statements regarding the positive interim Phase 1 data and potential benefits of MRT-8102, our expectations regarding the potential of MRT-8102 to transform the treatment of ASCVD and other cardiovascular and cardiometabolic diseases, our belief that our data supports the potential of MRT-8102 to be an oral best-in-class therapeutic among agents targeting the NLRP3/ IL-1/IL-6 pathway and establish the significant potential of MRT-8102 in multiple chronic inflammatory diseases, including ASCVD, our statements regarding the expansion of our proof-of-concept GFORCE-1 study in subjects with elevated CVD risk and acceleration of the anticipated Phase 2 (GFORCE-2) study of MRT-8102 in ASCVD patients, our expectations regarding the timing for sharing data from the GFORCE-1 study of MRT-8102 and timing of initiation of a Phase 2 GFORCE-2 study of MRT-8102 in ASCVD, our statements and expectations regarding our evaluation of additional Phase 2 proof of concept studies in MASH, gout, and recurrent pericarditis, conditions strongly linked to NLRP3 pathway activation, statements regarding our expectations that our collaborator, Novartis, will initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026, our expectations regarding the submission of an IND application for a next-generation NEK7-directed MGD and timing thereof, our expectations to initiate a MODeFIRe-1 Phase 2 study of MRT-2359 in combination with a second-generation androgen receptor inhibitor in CRPC in 2026, as well as to present updated data from the ongoing Phase 1/2 study of MRT-2359 at the ASCO Genitourinary Cancers Symposium in February 2026, our expectations regarding the submission of an IND application for a CDK2 and/or cyclin E1-directed MGD and timing thereof, statements regarding the clinical significance of the clinical data read-out at upcoming scientific meetings and timing thereof, statements around our ability to capitalize on and potential benefits resulting from our research and translational insights, 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, 2024, filed with the U.S. Securities and Exchange Commission on March 20, 2025, most recent Quarterly Reports on Form 10-Q 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.

Investors
Andrew Funderburk
ir@monterosatx.com

Media
Cory Tromblee, Scient PR
media@monterosatx.com

FAQ

What were the key hsCRP results for MRT-8102 in the Phase 1 Part 3 (GLUE)?

In 24 subjects dosed for 4 weeks, median hsCRP decreased by 85% and 94% reached hsCRP <2 mg/L from a median baseline of 6.3 mg/L.

How much NEK7 degradation did MRT-8102 achieve in the Phase 1 study (GLUE)?

MRT-8102 produced sustained NEK7 degradation of approximately 80–90% in peripheral blood T cells across 5–400 mg dose levels.

What safety signals were reported for MRT-8102 in the interim Phase 1 data (GLUE)?

Safety was reported as favorable with mostly mild to moderate adverse events and no evidence of increased infection risk.

When will Monte Rosa (GLUE) report further MRT-8102 trial results and start Phase 2?

The company anticipates a GFORCE-1 readout in H2 2026 and plans to initiate a Phase 2 ASCVD study in 2026.

Did MRT-8102 affect IL-6 levels in the Phase 1 interim data (GLUE)?

Yes; median IL-6 levels dropped by 55% in high CRP subjects, and two subjects had a 75% CSF IL-6 decrease.

What dose range was evaluated for MRT-8102 in the Phase 1 study (GLUE)?

Single and multiple ascending dose cohorts evaluated MRT-8102 at doses ranging from 5 mg to 400 mg.