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.
Voyager Therapeutics (NASDAQ: VYGR) presented six-month Good Laboratory Practice (GLP) toxicology data for VY1706, its investigational blood-brain-barrier-crossing AAV gene therapy targeting tau for Alzheimer's disease, in a Developing Topics late-breaking poster at AAIC 2026 in London on Monday July 13, 2026. The updated six-month data extends the prior three-month timepoint (64% reduction reported earlier this month): a single intravenous dose delivered sustained tau protein reduction up to 75% in key brain regions of non-human primates over six months. VY1706 was well tolerated with no adverse clinical pathology and no histopathological findings up to the highest dose tested. Notably, the program showed none of the typical AAV liver transaminase elevations at any dose level throughout six months, plasma neurofilament levels remained generally stable with no dose-related increases, and there were no cellular immune activations. Voyager received FDA Investigational New Drug (IND) clearance for VY1706, enabling initiation of a clinical trial in adults with early Alzheimer's disease with dosing expected in the second half of 2026.
Eisai announced Monday July 13, 2026 that its investigational anti-microtubule-binding region (MTBR) tau antibody etalanetug (development code E2814) reduced levels of plasma extracellular MTBR-tau243 (eMTBR-tau243), a novel fluid biomarker of Alzheimer's disease tau tangle pathology, in findings presented during a Featured Research Session at AAIC 2026 in London. Etalanetug reduced plasma eMTBR-tau243 by 78% at 3 months and by more than 90% at 9 months. The biomarker was largely absent in healthy adults and detected only in patients with dominantly inherited Alzheimer's disease (DIAD), suggesting it reflects disease-related tau pathology at the pathological source (neurofibrillary tangle formation) rather than tau physiology broadly. eMTBR-tau243 consists of tau fragments that include amino acid residue 243 and MTBR sequences, arising during the formation of neurofibrillary tangles, and can now be measured with a blood test to track tau pathology non-invasively. Etalanetug is Eisai's second-generation Alzheimer's antibody program beyond lecanemab (LEQEMBI, amyloid protofibril-directed), extending the company's franchise from amyloid to tau.
Longeveron (NASDAQ: LGVN) presented additional CLEAR MIND Phase 2a clinical data analysis for laromestrocel, its investigational allogeneic mesenchymal stem cell (Medicinal Signaling Cell) therapy, at AAIC 2026 in London on Monday July 13, 2026 from 7:30 AM-4:15 PM BST. The poster titled 'Laromestrocel Stabilizes Brain Inflammation In Key Alzheimer's Disease Gray And White Matter Regions As Assessed Using Free Water MRI' extends the CLEAR MIND Phase 2a program that Longeveron first published in Nature Medicine in March 2025. Free water MRI, a diffusion-based imaging technique that quantifies extracellular water and correlates with neuroinflammation, showed that laromestrocel-treated patients maintained stable brain inflammation levels in key gray and white matter regions relevant to Alzheimer's disease pathology. The findings support a clinically relevant and durable anti-inflammatory mechanism of action for laromestrocel and indicate potential blood biomarker correlates for tracking treatment response. Laromestrocel is administered as an intravenous infusion; the program targets neuroinflammation as a disease-modifying mechanism distinct from amyloid and tau approaches.
Denali Therapeutics (NASDAQ: DNLI) co-founder and CEO Ryan Watts, PhD delivered the opening plenary address at the Alzheimer's Association International Conference (AAIC) 2026 in London on Sunday July 12, 2026, titled 'Accelerating the Discovery and Development of Medicines for Neurodegeneration.' The presentation covered advances in neurodegeneration biology, biomarkers for diagnosis and treatment-effect assessment, and biologic therapies designed to cross the blood-brain barrier. Denali's proprietary TransportVehicle (TV) platform leverages the body's iron transport system (transferrin receptor) to shuttle antibodies, enzymes, and oligonucleotides into the brain. AVLAYAH (tividenofusp alfa-eknm) received FDA accelerated approval March 2026 as the first FDA-approved biologic specifically designed to cross the blood-brain barrier, for the treatment of neurologic manifestations of Hunter syndrome in certain pediatric patients. DNL628 is enabled by Denali's Oligonucleotide TransportVehicle (OTV) and targets the MAPT gene encoding tau, with data expected 1H 2027; DNL921 is a separate Alzheimer's candidate with Phase 1/2b data expected in 2027. The plenary framing ties to the Lonza-Nona Biosciences TfR1 blood-brain-barrier deal covered in Saturday's digest.
Eisai and Biogen announced Sunday July 12, 2026 that new clinical data presented at AAIC 2026 in London support that the LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers efficacy and safety comparable to intravenous (IV) administration in people with early Alzheimer's disease. Data were featured during the Developing Topics Session titled 'Lecanemab Subcutaneous Formulation in Early Alzheimer's Disease: Emerging Clinical Evidence and Practical Use Considerations,' covering the SC formulation, long-term use across diverse patient groups, maintenance dosing, and at-home administration. The findings support a fully subcutaneous treatment pathway from initiation through maintenance treatment, offering greater convenience and flexibility for patients and care partners. The FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025; the SC autoinjector data at AAIC 2026 extends that framework to initial treatment and long-term dosing. Lecanemab is a humanized IgG1 monoclonal antibody selective for amyloid protofibrils; the July 12 dataset is peptide-adjacent to the broader biologic-CNS delivery coverage.
Voyager Therapeutics (NASDAQ: VYGR) presented Developing Topics late-breaking poster data at AAIC 2026 in London (July 12-15) featuring VY1706, its investigational blood-brain-barrier-crossing AAV gene therapy targeting intracellular and extracellular tau for Alzheimer's disease. The 3-month GLP non-human primate toxicology study showed VY1706 was well tolerated at a single intravenous dose up to the highest level tested (5E13 vg/kg), with no adverse clinical pathology or histopathological findings. Tau protein was reduced up to 64% in key brain regions of non-human primates at 13 weeks following a single IV dose. Voyager received FDA Investigational New Drug (IND) clearance for VY1706 in H1 2026, enabling initiation of a clinical trial in adults with early Alzheimer's disease with dosing expected in the second half of 2026. The program extends the same BBB-delivery-plus-tau-reduction thesis that Denali's DNL628 OTV pursues via anti-tau ASO; both address the same therapeutic hypothesis through different modalities (AAV gene therapy vs. anti-sense oligonucleotide).
Biogen (NASDAQ: BIIB) will present Phase 2 CELIA study data for diranersen (BIIB080), an investigational tau-targeting antisense oligonucleotide (ASO), at AAIC 2026 in London during the Developing Topics in Phase 2 Clinical Trials session on Tuesday July 14, 2:00–3:30 PM BST. The 18-month CELIA study evaluated diranersen in patients with early Alzheimer's disease and is the first study to show reduction in tau pathology and cognitive benefit for a tau-targeted therapy. Biogen will present clinical, biomarker, and safety data that build on the May 2026 topline announcement and further characterize the molecule as the program advances toward Phase 3 development. Diranersen targets MAPT RNA to reduce tau production at its source, a differentiated approach to addressing abnormal tau both inside and outside neurons. The CELIA readout is a peptide-adjacent nucleic-acid biologic milestone that shifts the tau treatment conversation from 'reducing pathology' to 'reducing pathology and moving cognition.'
Acumen Pharmaceuticals (NASDAQ: ABOS) will present data on its Enhanced Brain Delivery (EBD) technology and early Alzheimer's disease insights for sabirnetug (ACU193) at AAIC 2026 in London (July 12-15, both in-person and online). Sabirnetug is a humanized monoclonal antibody discovered and developed based on its selectivity for soluble amyloid-beta oligomers (AβOs, a highly toxic and pathogenic form of Aβ) relative to Aβ monomers and amyloid plaques. Soluble AβOs bind to neurons, inhibit synaptic function, and induce neurodegeneration; the mechanism differentiates sabirnetug from plaque-directed anti-amyloid antibodies (lecanemab, donanemab) that clear fibrillar Aβ. Acumen advances sabirnetug in the ongoing Phase 2 ALTITUDE-AD trial in early symptomatic AD, following positive Phase 1 INTERCEPT-AD results. Topline ALTITUDE-AD results are expected in late 2026. The Enhanced Brain Delivery technology component further connects to the day's broader BBB-delivery theme anchored on Denali's opening plenary and the Lonza-Nona deal.
The Alzheimer's Association International Conference (AAIC 2026) opens Sunday July 12 and runs through Wednesday July 15 at the ExCeL London, drawing approximately 12,000 researchers and health-care professionals from around the globe. The peptide-adjacent centerpiece already flagged in Wednesday's Vaccinex announcement is the Featured Research Session on Monday July 13 for pepinemab (humanized IgG4 anti-Semaphorin 4D monoclonal antibody), chaired by Elizabeth Evans, PhD, presenting new glial biomarker data from the Phase 1b/2 SIGNAL-AD study alongside plans for the expanded Phase 2b SIGNAL-AD2 trial. AC Immune (NASDAQ: ACIU) will present three programs from its Morphomer platform: a first-in-class TDP-43 PET tracer with encouraging early human imaging data in frontotemporal dementia and ALS, a novel brain-penetrant NLRP3 inhibitor in Phase 1 that supports an orally delivered CNS therapy profile, and an alpha-synuclein Morphomer showing potent, brain-penetrant inhibition of pathology with neuroprotective effects. Eisai will present 50-plus abstracts spanning the lecanemab (LEQEMBI) Alzheimer's disease portfolio, including biomarker, long-term safety, and clinical-utility readouts.
AstraZeneca and Ionis Pharmaceuticals announced Thursday July 9, 2026 that the Phase 3 CARDIO-TTRansform trial of Wainua (eplontersen) did not meet its primary efficacy endpoint in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). The trial enrolled over 1,400 patients and was the largest Phase 3 study conducted in the ATTR-CM population to date; the primary endpoint was a composite of cardiovascular mortality and recurrent CV clinical events through 140 weeks compared with placebo. Prespecified subgroup analyses showed nominally significant reductions in composite events with eplontersen monotherapy versus placebo, while patients also receiving a baseline TTR stabilizer showed no incremental effect. Eplontersen is an antisense oligonucleotide (a nucleic-acid therapeutic modality distinct from peptides but adjacent in the metabolic-and-cardiovascular therapeutic territory this site tracks); the drug is already FDA-approved as Wainua for hereditary transthyretin amyloidosis polyneuropathy. Full CARDIO-TTRansform results will be presented at the European Society of Cardiology (ESC) Congress in August 2026. AstraZeneca and Ionis shares fell on the readout.
Vaccinex (NASDAQ: VCNX) announced Wednesday July 8, 2026 that it will present new glial biomarker data from the Phase 1/2 SIGNAL-AD study of pepinemab and plans for the expanded Phase 2B SIGNAL-AD2 trial at the Alzheimer's Association International Conference (AAIC) 2026 in London on July 13. Elizabeth Evans, PhD, Chief Operating Officer and Senior VP of Discovery and Translational Medicine, will chair the Featured Research Session. Pepinemab is a humanized IgG4 monoclonal antibody targeting Semaphorin 4D (SEMA4D). The mechanism blocks SEMA4D signaling through astrocyte plexin-B1 receptors, reducing reactive astrocyte activation and downstream neuroinflammation — a disease-modifying approach mechanistically distinct from amyloid- or tau-targeting strategies. Pepinemab is a monoclonal antibody rather than a peptide, but the SEMA4D program sits in the peptide-and-biologic neurodegeneration territory this site tracks alongside the Vera Therapeutics Trutakna (atacicept fusion protein) approval covered yesterday. AAIC readouts to watch: cerebrospinal-fluid glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) biomarker shifts on pepinemab treatment.
On July 7, Kailera Therapeutics reported positive topline results from two Hengrui Pharma Phase 3 trials in China of HRS-7535/KAI-7535, a once-daily oral small-molecule GLP-1 receptor agonist licensed to Kailera outside Greater China. In HARBOR-1, 556 adults with obesity or overweight lost a mean 9.5% of body weight at 120 mg and 10.9% at 180 mg by week 44. OUTSTAND-2, in 810 adults with type 2 diabetes, showed HbA1c reductions of 1.50% to 1.68% and non-inferiority versus dapagliflozin. Hengrui plans China NDA filings; Kailera is running a parallel global Phase 2.
A Phase 1/2 study (NCT07637786) of ONVAX-01, a personalized peptide nanovaccine, in combination with an anti-PD-1 antibody and standard-of-care chemotherapy in patients with advanced pancreatic cancer began recruiting in late June 2026. The trial design has participants receive doses of the nanovaccine along with intravenous infusions of an anti-PD-1 checkpoint inhibitor plus chemotherapy, with serial imaging and blood-marker monitoring for tumor response. ONVAX-01 sits in the same broad therapeutic space as Elicio Therapeutics' ELI-002 7P (which missed its Phase 2 AMPLIFY-7P primary disease-free survival endpoint on June 15) but with a different delivery vehicle (nanoparticle self-assembly versus amphiphile-modified CpG oligonucleotide adjuvant). KRAS mutations drive approximately 90% of pancreatic ductal adenocarcinoma cases and 50% of colorectal cancers, making KRAS-targeting peptide vaccines one of the highest-impact unmet targets in solid-tumor oncology. The peptide nanovaccine modality has roots in 2022 case-report literature on neoantigen nanovaccine immunotherapy in advanced pancreatic cancer and broader nanovaccine work using DP7-C antimicrobial peptide as carrier-plus-adjuvant.
Elicio Therapeutics announced June 15, 2026 that the randomized Phase 2 AMPLIFY-7P study of ELI-002 7P (a 7-peptide formulation targeting the seven most common KRAS mutations, combined with the ELI-004 amphiphile-modified CpG oligonucleotide adjuvant) in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma did not meet its pre-specified primary disease-free survival (DFS) endpoint in the intent-to-treat population. Post-hoc landmark analyses, however, showed a consistent 14% absolute DFS benefit during active treatment at both 3 and 6 months, with treatment-arm separation persisting through 9 months — suggesting early clinical activity that waned over time. Elicio is refining its Phase 3 development strategy based on the data. The 7P formulation extends the 2-peptide ELI-002 2P AMPLIFY-201 program covered in this site's April 29 digest (Nature Medicine publication, durable T-cell responses, median RFS not reached vs 3.02 months in non-responders). KRAS mutations drive roughly 90% of pancreatic cancers and 50% of colorectal cancers, making the KRAS peptide vaccine class one of the highest-impact targets in solid-tumor oncology.
HLB Therapeutics (KOSDAQ: 115450) announced in late May 2026 that its US subsidiary ReGenTree failed to meet the primary endpoint in the European Phase 3 SEER-3 trial of RGN-259, a thymosin beta-4-based eye drop designed to rival Dompé's Oxervate (cenegermin) — the only FDA-approved prescription drop for neurotrophic keratitis. The trial did not show a statistically significant difference in complete corneal healing at 4 weeks compared to placebo, with a company spokesperson telling Korea Biomedical Review that 'a stronger-than-expected placebo effect in the control arm led to a puzzling outcome.' RGN-259 is licensed from RegeneRx and is also in Phase 3 development for dry eye syndrome (ARISE-3). HLB Therapeutics CEO Ahn Gi-hong said the company will analyze the SEER-3 results and focus resources on the ongoing US Phase 3 SEER-2 trial, with topline H2 2026.
NervGen Pharma (Nasdaq: NGEN) confirmed in its Q1 2026 results (early May) that the RESTORE registrational Phase 3 study of NVG-291 in chronic tetraplegia (cervical chronic spinal cord injury, SCI) remains on track for mid-2026 initiation after a successful FDA End-of-Phase 2 meeting. NVG-291 is a subcutaneous peptide mimetic of the intracellular signaling domain of intracellular sigma peptide (ISP), designed to plasticize neural pathways and enable functional recovery in chronic SCI — a first-in-class mechanism where no pharmacological intervention has shown durable motor recovery before. The expanded chronic CONNECT SCI Phase 1b/2a data (n=10 active vs n=10 placebo) showed a three-fold increase in motor connectivity to the first dorsal interosseus hand muscle. Biomechanical gait analysis from an independent movement-intelligence firm is expected Q2 2026 to disentangle genuine neural recovery from compensatory mechanics. Cash was $16.6M as of March 31, 2026 (listed Nasdaq Jan 8, 2026).
EndoCyclic Therapeutics announced FDA clearance of the Investigational New Drug (IND) application for ENDO-205 on March 23, 2026. ENDO-205 is a first-in-class non-hormonal precision peptide therapeutic for endometriosis, designed to eliminate lesions rather than modulate hormones — distinguishing it from all currently approved endometriosis therapies, which are either oral GnRH antagonists (elagolix, relugolix) or hormonal contraceptives. In preclinical models, ENDO-205 eliminated endometriosis lesions and associated inflammation with no safety signals in GLP toxicology studies. The Phase 1 will enroll healthy pre-menopausal women of reproductive age. Endometriosis affects roughly 10% of women of reproductive age globally, with a 6-10 year average diagnostic delay and no curative therapy.
Marea Therapeutics (Endocrine News Pharma Friday, June 19) released Phase 1 first-in-human data for MAR002, a first-in-class half-life-extended allosteric human monoclonal antibody growth hormone receptor antagonist (GHRA), at ENDO 2026 in Chicago. The Phase 1 readout supports a potential best-in-disease profile across safety, tolerability, pharmacodynamic IGF-1 lowering, and pharmacokinetics, with a long duration of action compatible with infrequent subcutaneous dosing — potentially once every two weeks — versus the daily subcutaneous administration required for pegvisomant (Somavert). MAR002 sits at the intersection of acromegaly's existing somatostatin (octreotide, lanreotide, Palsonify), GH-receptor (pegvisomant), and dopamine agonist (cabergoline) approaches and reframes the GHR antagonist class around an antibody, not a pegylated protein. Acromegaly's US/EU prevalence is roughly 40-70 per million.