Peptide News Digest

Clinical Trials News

229 stories across all digests

Clinical trial coverage on Peptide News Digest pulls in Phase 1 through Phase 3 readouts across the peptide universe — GLP-1 obesity and cardiometabolic trials (SELECT, SURMOUNT-4, ACHIEVE-3, REDEFINE-1, SYNCHRONIZE-1), peptide vaccine work (AMPLIFY-201, MEL39), peptide-drug conjugate trials, and antimicrobial peptide programs.

Most of the noise sits with Lilly and Novo, but the interesting reads are usually elsewhere: Bicycle Therapeutics on solid tumors, Lirum on Ewing sarcoma, Cerapedics on lumbar fusion, Pelage on hair loss. Real-world evidence and registry data also land here when they reframe what the randomized trials showed.

Each entry names the sponsor, the phase, and the endpoint. Browse the latest below, or jump to the readouts by drug at #semaglutide, #tirzepatide, or #orforglipron.

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Assembly Biosciences ABI-6250 Phase 1a Topline at EASL 2026: First-in-Class Oral HDV Entry Inhibitor — The Small-Molecule Competitor to Gilead's Just-Approved Bulevirtide Peptide

Assembly Biosciences presented topline Phase 1a data on ABI-6250 at EASL 2026 (poster WED-579, Dr. Edward Gane, University of Auckland) — a first-in-class oral hepatitis D virus (HDV) entry inhibitor. The Phase 1a study evaluated safety, pharmacokinetics, and pharmacodynamic activity in healthy participants; the data supports advancing directly into a Phase 2 study by year-end. ABI-6250 is the only oral entry inhibitor in development for chronic HDV. The mechanistic context matters: Gilead's Hepcludex (bulevirtide) — a 47-amino-acid injectable lipopeptide NTCP entry inhibitor — just won FDA accelerated approval May 22 as the first US HDV treatment. ABI-6250 targets the same entry-inhibition step but as an oral small molecule rather than an injectable peptide, positioning it as a potential next-generation convenience competitor in the small but newly-validated HDV market. Assembly also announced May 22 an expansion of ABI-6250 development into cholestatic liver diseases. The peptide-vs-small-molecule dynamic in HDV mirrors the same competition that played out in GLP-1 (injectable semaglutide vs oral orforglipron).

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Altimmune Pemvidutide IMPACT Phase 2b qFibrosis Data Released (May 27 LBP-036, 08:30 CEST): HistoIndex Digital Pathology Shows Significant Fibrosis Regression at 24 Weeks With Concurrent NIT and Cardiovascular-Marker Improvements

Altimmune released new analyses from the IMPACT Phase 2b trial today at EASL 2026 Barcelona. The late-breaking poster LBP-036 (Dr. Shaheen Tomah, 08:30 CEST) reported pemvidutide treatment produced concurrent improvements across multiple non-invasive tests of MASH activity and fibrosis, with HistoIndex qFibrosis digital-pathology analysis documenting significant fibrosis-stage improvements at 24 weeks versus placebo. The trial randomized 212 biopsy-confirmed MASH patients (F2-F3 fibrosis, with and without diabetes) to weekly subcutaneous pemvidutide 1.2 mg, 1.8 mg, or placebo over 48 weeks. Companion data on response analysis across NITs of liver inflammation/fibrosis and cardiovascular measures landed in additional posters. The abstract carries the EASL committee's 'Best of EASL 2026' top-tier selection. Pemvidutide is a 1:1 balanced GLP-1/glucagon dual receptor agonist peptide with FDA Fast Track + Breakthrough Therapy Designations for MASH; oral presentation Thursday May 28 at 17:00 CEST anchors the 48-week efficacy and safety data.

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MetaVia DA-1726 Higher-Dose Phase 1 EASL 2026 Late-Breaking Poster: 48 mg Cohort Safety, Tolerability, Pharmacokinetics + Exploratory Noninvasive Liver Assessment in GLP-1/Glucagon Dual Oxyntomodulin Analog

MetaVia presented late-breaking Phase 1 data on DA-1726 at the EASL Congress 2026 today in Barcelona. The poster titled 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue, in a Higher-Dose Phase 1 Cohort with Exploratory Noninvasive Liver Assessment' covers the 48 mg dose level. DA-1726 is a once-weekly subcutaneous oxyntomodulin analog functioning as a GLP-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist for obesity and MASH. The 4-week Phase 1 MAD trial earlier in 2026 documented compelling weight loss with best-in-class potential glucose control (GLP-1R arm), waist reduction (GCGR arm), and tolerability profile. The current 16-week Phase 1 Part 3 titration study is designed to optimize higher-dose levels and tolerability with full data expected Q4 2026. The EASL poster extends the early-phase MASH biomarker package and supports the planned Phase 2 advancement.

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Arrowhead Pharmaceuticals ARO-INHBE EASL 2026 (May 27): RNAi-Based Activin E/ALK7 Pathway Therapeutic Cuts Liver Fat 44% at ≥200 mg; Doubles Weight Loss + Triples Fat Reduction in Combination With Tirzepatide

Arrowhead Pharmaceuticals presented Phase 1/2a interim clinical data on ARO-INHBE at EASL 2026 today (Rinki Murphy, MBChB, PhD presenting). ARO-INHBE is an RNAi therapeutic targeting the Activin E/ALK7 pathway — a genetically validated regulator of adipose fat storage. The data: a single 400 mg dose produced 85.3% mean maximum Activin E reduction with persistent effect beyond 3 months; ≥200 mg doses reduced liver fat 44%. In combination with low-dose tirzepatide 5 mg in obese patients with type 2 diabetes, ARO-INHBE doubled weight loss and tripled reductions in visceral fat, total fat, and liver fat versus tirzepatide alone. Effect persists through Week 24 supporting potential twice-yearly dosing. Arrowhead is engaging with regulatory authorities on Phase 2 designs in MASH and obesity. The combination data is the strongest evidence to date that adding a non-GLP-1 mechanism to incretin therapy can meaningfully amplify body-composition outcomes — a contrast to the GLP-1-alone monotherapy story that has dominated obesity-pharmacology since 2021.

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Dana-Farber NeoVax Personalized Neoantigen Peptide Vaccine + Pembrolizumab in Newly Diagnosed Glioblastoma — Phase 1 ASCO 2026 Data Shows Anti-Tumor Activity Persisting Past One Year

Dana-Farber Cancer Institute researchers led by David Reardon (Director, Center for Neuro-Oncology) and Catherine Wu (Chief, Division of Stem Cell Transplantation and Cell Therapies) presented Phase 1 data at ASCO 2026 on NeoVax — a personalized neoantigen peptide vaccine — combined with pembrolizumab in newly diagnosed glioblastoma. The study excluded dexamethasone (an immune suppressant) and added pembrolizumab to enhance anti-tumor activity. Vaccine-stimulated anti-tumor activity was still evident in some patients after one year, with vaccine-specific T cells migrating into the brain and tumors following vaccination. The MGMT-methylated patient subgroup showed median survival meaningfully exceeding historical observations, though the authors emphasized this requires cautious interpretation given the lack of a randomized comparator arm. The timing of pembrolizumab administration didn't affect immune-response stimulation, but pembrolizumab-before-NeoVax-priming may extend overall survival. NeoVax adds to the personalized neoantigen vaccine cohort (BioNTech autogene cevumeran, Moderna intismeran autogene, Evaxion EVX-01) anchoring the broader peptide cancer vaccine field.

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Novo Nordisk ESSENCE Japanese MASH Subgroup + Menopausal Women Analyses Land at EASL 2026 Day 1 — Extending Semaglutide MASH-with-Fibrosis Approval Toward Underrepresented Populations

Novo Nordisk presented two ESSENCE Phase 3 subgroup analyses at EASL 2026 today. The Japanese MASH subgroup analysis extends the semaglutide 2.4 mg efficacy and safety case to Asian populations where MASLD and MASH develop at lower body-mass-index thresholds and involve distinct metabolic risk profiles. The Menopause subgroup analysis covers women in menopause, where hormonal changes accelerate liver disease progression and metabolic deterioration. Both analyses show consistent hepatic safety profile and efficacy across the underrepresented groups. The August 2025 FDA MASH-with-fibrosis approval of semaglutide 2.4 mg was based on the broader ESSENCE Phase 3 cohort; the EASL Day 1 presentations strengthen the global labeling case across non-Western populations and the menopausal-women subgroup that has historically been underrepresented in MASH clinical trials. Real-world evidence data presented today documents quality-of-life impairment and healthcare-cost escalation in MASH patients.

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Madrigal Rezdiffra EASL 2026 Day 1 Eight-Poster Data Drop (May 27): Cardiovascular Lp(a)/LDL-C/ApoB Reductions + ANTICIPATE-NASH Portal Hypertension Risk Score Improvement in Compensated F4c MASH Cirrhosis

Madrigal Pharmaceuticals delivered eight Rezdiffra (resmetirom) poster presentations at EASL 2026 today. Key data: secondary analysis of MAESTRO-NASH and MAESTRO-NAFLD-1 documented Rezdiffra-driven improvements in cardiovascular lipid risk markers (Lp(a), LDL-C, ApoB); a two-year analysis in patients with compensated MASH cirrhosis (F4c) showed meaningful improvement in ANTICIPATE-NASH risk scores, a validated marker for clinically significant portal hypertension. Real-world effectiveness analyses and noninvasive biomarker plus machine-learning models for predicting MASH and fibrosis improvement rounded out the presentation slate. Rezdiffra (resmetirom) — a thyroid hormone receptor β agonist small molecule, not a peptide — was approved March 2024 as the first FDA-approved MASH therapy for noncirrhotic MASH with F2-F3 fibrosis. The compensated MASH cirrhosis (F4c) data extend the case toward an indication where the GLP-1/glucagon peptide programs (pemvidutide IMPACT, survodutide SYNCHRONIZE-1, retatrutide MASLD Phase 3) are also competing.

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Aktis Oncology AKY-2519 First-in-Human Imaging + Dosimetry Data: B7-H3-Targeting Miniprotein Radioconjugate Shows Robust Tumor Uptake in mCRPC and Solid Tumors (ASCO 2026)

Aktis Oncology released first-in-human clinical imaging and dosimetry data on AKY-2519 ahead of ASCO 2026. AKY-2519 is a miniprotein radioconjugate — a small synthetic protein scaffold (akin to engineered peptide architecture) linked to a therapeutic radionuclide — targeting B7-H3, an antigen overexpressed in multiple solid tumors including metastatic castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer. The Phase 1 data demonstrated robust tumor uptake and limited normal-tissue exposure across multiple B7-H3-expressing tumor types. Two ASCO 2026 poster presentations cover the imaging and dosimetry results. The FDA cleared the IND for AKY-2519 in March 2026; a Phase 1b clinical trial in mCRPC patients is ongoing, with a second Phase 1b in various B7-H3-expressing tumor types expected to initiate in H2 2026. AKY-2519 joins Novartis's Pluvicto (PSMA-617) and Lutathera (DOTATATE) in the small but growing class of peptide-related radioconjugates with first-in-human or commercial validation.

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Galectin Therapeutics Belapectin NAVIGATE Trial EASL 2026 (May 27): New Oral and Poster Analyses on Disease-Modification Potential in Advanced MASH Cirrhosis

Galectin Therapeutics announced oral and poster presentations today at EASL 2026 covering new analyses from the global Phase 3 NAVIGATE trial of belapectin in advanced MASH cirrhosis. Belapectin is a galectin-3 inhibitor (a carbohydrate-based, not strictly peptide, therapeutic) developed for compensated MASH cirrhosis — the indication that current FDA-approved MASH therapies (Madrigal's Rezdiffra, August 2025-approved semaglutide) do not yet directly address. The NAVIGATE trial is designed to demonstrate disease-modification potential in compensated MASH cirrhosis (F4c) — the patient population at highest risk of progression to decompensated cirrhosis and hepatocellular carcinoma. The Galectin data sits alongside Madrigal's parallel EASL data on Rezdiffra cardiovascular and portal-hypertension markers from MAESTRO-NASH/MAESTRO-NAFLD-1 secondary analyses, completing the non-peptide MASH-treatment context for the GLP-1/glucagon peptide programs at the meeting.

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Sagimet Biosciences Denifanstat + Resmetirom MASH Combination EASL 2026 Posters (May 27): FASN Inhibitor + Madrigal's Rezdiffra as Combination MASH Therapy Test

Sagimet Biosciences presented two posters at EASL 2026 today on the combination of its denifanstat (FASN inhibitor small molecule) with Madrigal's Rezdiffra (resmetirom, thyroid hormone receptor β agonist) for MASH. The combination work tests whether layered MASH therapies producing complementary mechanism-of-action effects can outperform either monotherapy. Denifanstat inhibits fatty acid synthase — the enzyme producing the majority of newly synthesized fatty acids in the liver — reducing hepatic lipogenesis upstream of the inflammation and fibrosis cascade that resmetirom addresses through downstream thyroid-hormone-receptor mechanisms. The combination represents the broader trend of MASH-as-multi-mechanism-battleground that defines EASL 2026: GLP-1/glucagon peptides (pemvidutide, DA-1726, survodutide), RNAi (ARO-INHBE), thyroid hormone agonism (Rezdiffra), FASN inhibition (denifanstat), and galectin-3 inhibition (belapectin) all running parallel programs.

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Sapience Therapeutics Lucicebtide Phase 2 GBM Specific Data Point: 28.4-Month Projected Median PFS Versus 4.0-6.9 Month Historic Benchmark in Newly Diagnosed Glioblastoma

Sapience Therapeutics' May 21 ASCO 2026 data update on lucicebtide (ST101) — a first-in-class C/EBPβ peptide antagonist — included a specific data point worth surfacing for the Tuesday cycle. In the Phase 2 Window-of-Opportunity study (n=9 evaluable as of April 27 data cutoff), patients with newly diagnosed glioblastoma (ndGBM) treated with lucicebtide plus standard-of-care chemoradiation achieved a projected median progression-free survival of 28.4 months — meaningfully exceeding the 4.0-6.9 month historic benchmark range. Six of nine patients remain alive past 22.3 months against a historical median OS range of 14.6-17.0 months. Median overall survival has not yet been reached. Lucicebtide crossed the blood-brain barrier with confirmed tumor uptake and target engagement via negative enrichment of the C/EBPβ regulon in tumor and myeloid cells. The poster session is scheduled for Monday June 1.

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Altimmune Pemvidutide EASL 2026 IMPACT Phase 2b — Late-Breaking Fibrosis Regression Poster Wednesday May 27 in MASH

Altimmune presents IMPACT Phase 2b clinical trial data on pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) at the European Association for the Study of the Liver Congress 2026 (May 27-30 Barcelona). The randomized, placebo-controlled, double-blind Phase 2b trial enrolled 212 biopsy-confirmed MASH patients with fibrosis stages F2 or F3 (with and without diabetes), randomized 1:2:2 to weekly subcutaneous pemvidutide 1.2 mg, 1.8 mg, or placebo for 48 weeks. The late-breaking poster Wednesday May 27 at 08:30 CEST reports the AI-based Liver Explore quantitative digital pathology analysis showing significant reductions in proportionate areas of early, advanced, and total liver fibrosis at 24 weeks. The non-invasive PRO-C3:CTX-III ratio reduced consistent with fibrosis regression. Pemvidutide is a GLP-1/glucagon dual-action peptide with FDA Fast Track designation for MASH plus Breakthrough Therapy Designation. The approach competes directly with Boehringer Ingelheim's survodutide and Eli Lilly's retatrutide on the GLP-1/glucagon arm for MASH.

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Sapience Therapeutics Lucicebtide ASCO 2026 Phase 2 Update (May 22): First-in-Class C/EBPβ Peptide Antagonist Shows Durable PFS + OS in Window-of-Opportunity Newly Diagnosed Glioblastoma

Sapience Therapeutics announced May 22 positive Phase 2 clinical and pharmacodynamic data update from its lucicebtide (ST101) trial in glioblastoma ahead of the ASCO 2026 Annual Meeting (May 29-June 2 Chicago). The Phase 2 Window-of-Opportunity study evaluates lucicebtide alone and in combination with standard-of-care chemoradiation, with dosing both before and after surgical resection. Nine patients were evaluable for analysis; the maturing data show durable progression-free and overall-survival improvements with a well-tolerated safety profile. Lucicebtide is a first-in-class peptide antagonist of CCAAT/enhancer-binding protein β (C/EBPβ) — a transcription factor that drives tumor aggressiveness, immune evasion, and stemness in glioblastoma. The 125-patient program across recurrent GBM monotherapy and newly diagnosed combination cohorts is the largest peptide-mechanism dataset in GBM to date. The Monday June 1 poster session details the efficacy, pharmacodynamics, and safety in newly-diagnosed patients.

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Corbus Pharmaceuticals CRB-701 ASCO 2026 Pre-Meeting Detail (May 22): Phase 1/2 Nectin-4 ADC in HNSCC + Cervical Cancer; Oral Cervical Session May 29, HNSCC Poster May 30, Mid-2026 Registrational Study Start in 2L HNSCC

Corbus Pharmaceuticals announced ASCO 2026 abstracts featuring updated clinical data from the Phase 1/2 study of CRB-701 (SYS6002), a next-generation antibody-drug conjugate targeting Nectin-4. The oral presentation in cervical cancer is scheduled for Thursday May 29 at 4:57 PM CDT; the head and neck squamous cell carcinoma (HNSCC) poster on Friday May 30 at 4:30 PM CDT. The data will include clinical response durability and HNSCC patient-subgroup analysis. Corbus reached broad alignment with the FDA on registrational-study designs in second-line HNSCC and cervical cancer, enabling potential accelerated approval based on objective response rate and full approval on overall survival. The company expects to initiate a registrational study for CRB-701 in second-line HNSCC mid-2026. CRB-701 targets the same Nectin-4 antigen as enfortumab vedotin (Padcev) and Bicycle Therapeutics' zelenectide pevedotin — the second-line HNSCC opportunity is the segment where the three programs will compete most directly.

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TRIUMPH-1 Dysesthesia Signal Mechanism Discussion: 12.5% at 12 mg Tied to Glucagon-Receptor Activation, Dose-Dependent, Mild and Resolving in TRIUMPH-4 Follow-On

The TRIUMPH-1 dysesthesia signal (skin tingling, paresthesia-like sensations) that BMO Capital flagged Thursday merits a mechanistic look. The signal appeared in 12.5% of participants on retatrutide 12 mg in TRIUMPH-1, but was NOT reported in the Phase 2 retatrutide program. TRIUMPH-4 (December 2025 readout) recorded dysesthesia in approximately 20.9% of participants on the highest dose — most cases mild and resolving during ongoing treatment. The mechanistic explanation is tied to retatrutide's glucagon-receptor activation: glucagon signaling drives small-fiber sensory neuropathy patterns through downstream effects on c-AMP-mediated nociceptor sensitization. The pattern is dose-dependent (4 mg essentially no signal, 9 mg modest, 12 mg the peak). The clinical question is whether dysesthesia stays mild and reversible at commercial scale or whether a small fraction of patients develop persistent or more severe sensory disturbances. The signal is the differentiator from tirzepatide (no glucagon arm) and semaglutide (no glucagon, no GIP).

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Retatrutide MASLD Phase 3 (NCT06859268) Enrollment Continues — 86% Phase 2 Liver-Fat Reduction Baseline; H1 2027 Topline Expected

Eli Lilly's retatrutide MASLD Phase 3 program (NCT06859268) continues enrollment across multiple international sites following the December 2025 Phase 2 readout that documented 86% mean liver-fat reduction at 48 weeks on 12 mg dosing. The Phase 3 trial enrolls adults with biopsy-confirmed MASH stages F2-F3 with primary endpoint at week 52 measuring MASH resolution without worsening of fibrosis. The 86% liver-fat reduction substantially exceeds the resmetirom 38-46% benchmark from the MAESTRO-NAFLD-1 reference cohort. Topline data is expected H1 2027; full results at AASLD or EASL 2027. The MASLD Phase 3 sits alongside TRIUMPH-3 (obesity + CVD) and TRIUMPH-OUTCOMES (10,000-patient cardiovascular outcomes trial reading 2027) as the second 2027 retatrutide catalyst. If positive, retatrutide files for MASH labeling alongside the obesity NDA — potentially within the same FDA submission window.

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Bicycle Therapeutics Duravelo-2 Phase 2 Detailed Data (May 22): 65% ORR (17/26) and 58% BICR-Confirmed ORR (15/26) at 27-Week Cutoff for Zelenectide Pevedotin + Pembrolizumab in 1L Urothelial Cancer

Bicycle Therapeutics' formal post-ASCO 2026 press release Friday morning specified the headline Phase 2 numbers from yesterday's abstract release. In the Duravelo-2 combination cohort, the optimal zelenectide dose plus pembrolizumab 200 mg every three weeks produced 65% ORR (17/26 evaluable patients) regardless of confirmation, with 58% BICR-confirmed ORR (15/26) at the 27-week cutoff in previously untreated locally advanced or metastatic urothelial cancer. An additional confirmed BICR response observed after the cutoff would bring the rate to 62%. The trial tested two dose schedules: 5 mg/m² weekly and 6 mg/m² two-weeks-on-one-week-off; the optimal dose moves forward in the Phase 3 expansion. Treatment retention was high and dose-limiting adverse events limited. The 65% Phase 2 ORR matches the 65% Phase 1 Duravelo-1 ORR (13/20) — pharmacology consistency across two different patient populations, an unusual durability signal for a peptide-drug conjugate.

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BriaCell ASCO 2026 Follow-On Press Release (May 22): Final Phase 2 Bria-IMT Median Overall Survival 16.6 Months in Heavily Pretreated Metastatic Breast Cancer With Phase 3 Formulation

BriaCell's formal post-ASCO 2026 press release Friday morning specified the headline number from yesterday's abstract release. Final Phase 2 median overall survival with Bria-IMT plus checkpoint inhibitor reached 16.6 months in heavily pretreated metastatic breast cancer patients using the Phase 3 formulation — a substantial improvement over historical post-ADC, post-CPI, post-CDK4/6-failure populations where median OS typically runs 8-10 months. The release also specified positive quality-of-life data from the ongoing Phase 3 study and biomarker analyses confirming the predictors of anti-cancer response observed in Phase 2 carry forward into the Phase 3 cohort. The three poster presentations plus three publication-only abstracts at ASCO 2026 (May 29-June 2) will detail 12- and 24-month survival, treatment tolerability, and circulating-tumor-cell biomarker work. The 16.6-month median OS sets the bar BriaCell needs to clear or beat in the ongoing Phase 3 to support its accelerated approval ambitions.