Phase 2 is where peptide programs prove dose, target engagement, and proof-of-concept efficacy before committing to Phase 3 capital. Coverage on this site has tracked Phase 2 readouts and trial initiations across metabolic, oncology, and pulmonary indications.
Recent Phase 2 activity covered here: Boehringer Ingelheim's first-in-class triple GLP-1/GIP/NPY2 agonist BI 3034701 advancing to Phase 2 in mid-2026; Rein Therapeutics' LTI-03 Phase 2 RENEW trial with 8 patients enrolled in idiopathic pulmonary fibrosis; Bicycle Therapeutics dosing the first patient in a Phase 2 nuzefatide pevedotin trial in recurrent pancreatic cancer (April 2026); and Biomea Fusion's icovamenib COVALENT-112 52-week Phase 2 type-1 diabetes data showing a 52% C-peptide AUC increase. Several Roche, Pfizer, and AstraZeneca obesity-pipeline assets sit in Phase 2 readouts due before year-end 2026.
Stories here cover Phase 2 readouts, dose-selection decisions, and the bridge to Phase 3. See #phase-3, #clinical-trials, and #dose-selection.
Silence Therapeutics (NASDAQ: SLN) announced positive topline results from the Phase 2 SANRECO trial of divesiran, a first-in-class TMPRSS6-targeting siRNA product candidate developed from the company's proprietary mRNAi GOLD platform. The trial enrolled 48 phlebotomy-dependent adults with polycythemia vera (PV) and evaluated divesiran 6 mg/kg administered subcutaneously every 6 weeks (Q6W) or every 12 weeks (Q12W) versus placebo over a 36-week randomized double-blind period. Results: 88% of divesiran-treated patients achieved a response versus 19% on placebo (P<0.0001), corresponding to a 69% placebo-adjusted response rate. How divesiran works: it silences TMPRSS6 (transmembrane serine protease 6) expressed almost exclusively in the liver; TMPRSS6 is a negative regulator of hepcidin, the body's master regulator of iron metabolism. By silencing TMPRSS6, divesiran increases hepcidin production and release by liver hepatocytes, which restricts iron availability to bone marrow and reduces the excessive red blood cell production that drives PV symptoms. Divesiran has FDA Fast Track and Orphan Drug designations for PV. Silence Therapeutics anticipates initiating a Phase 3 trial evaluating divesiran Q12W versus placebo in the first half of 2027. Shares rose sharply on the news, touching a 52-week high. The read-through extends the broader siRNA cardiometabolic and rare-disease franchise landscape that also includes Alnylam's Amvuttra and Arrowhead's Redemplo (plozasiran) in adjacent hepatic-target siRNA categories.
Kiniksa Pharmaceuticals (NASDAQ: KNSA) reported Q2 2026 financial results Tuesday July 28, 2026 with ARCALYST (rilonacept, an IL-1α and IL-1β cytokine trap fusion protein) net product revenue of $243.6 million, +55% year-over-year growth. ARCALYST is FDA-approved for the reduction in risk of recurrence of pericarditis in patients 12 years of age and older, and represents Kiniksa's primary commercial franchise. The Q2 revenue trajectory reflects continued cardiovascular-specialist adoption of rilonacept as a maintenance therapy alternative to colchicine-plus-corticosteroid regimens in the recurrent pericarditis population. Kiniksa separately reported Phase 2 data from the KPL-387 program (an investigational IL-1 receptor antagonist monoclonal antibody) showing rapid and sustained reductions in pain and inflammation at the 300 mg subcutaneous injection administered once monthly. The company hosted a conference call and webcast at 8:30 AM Eastern Time Tuesday July 28 to discuss Q2 financial performance and portfolio pipeline advancement including KPL-387 next-step development, ARCALYST commercial expansion, and additional pipeline candidates. Kiniksa Pharmaceuticals is one of the peptide-adjacent biotech companies focused on IL-1 pathway inhibition through both antibody and fusion-protein modalities.
Boehringer Ingelheim announced Thursday July 16, 2026 the start of a Phase 2 clinical trial evaluating BI 3034701, its investigational triple GLP-1/GIP/NPY2 receptor agonist peptide, in patients with obesity and overweight. BI 3034701 is a potential first-in-class triple agonist designed to activate three complementary biological pathways: GLP-1 and GIP receptors reduce appetite and regulate metabolism, and the neuropeptide Y2 (NPY2) receptor modulates central hunger signaling. Phase 1 studies previously showed a generally favorable safety and tolerability profile that supported advancing the program. BI 3034701 is based on Gubra-discovered technology and licensed to Boehringer Ingelheim, which is responsible for global clinical development and commercialization. The program adds a distinct third target to the emerging next-generation obesity landscape: Eli Lilly's retatrutide (GLP-1/GIP/glucagon triple agonist in TRIUMPH Phase 3), Novo Nordisk's UBT251 (GLP-1/GIP/glucagon triple in Phase 1/2a), and Boehringer's dual glucagon/GLP-1 survodutide (Phase 3, 16.6% weight loss in obesity). The NPY2 receptor target is novel to the class and could carry a distinct safety and tolerability profile alongside the incretin-plus-incretin backbone.
Biogen (NASDAQ: BIIB) presented full Phase 2 CELIA study data for diranersen (BIIB080), an investigational tau-targeting antisense oligonucleotide (ASO) delivered intrathecally, at AAIC 2026 in London on Tuesday July 14, 2026 during the Developing Topics in Phase 2 Clinical Trials Session (2:00-3:30 PM BST). The 76-week placebo-controlled study evaluated three doses (60 mg every 24 weeks, 115 mg every 24 weeks, and 115 mg every 12 weeks) and did not meet its primary endpoint of dose response on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at Week 76. Strong reductions in tau pathology occurred across all studied doses, generally consistent with the Phase 1b study. Prespecified analyses of cognitive endpoints demonstrated slowing of clinical decline across all doses, with the effect particularly pronounced at the lowest 60 mg q24w dose. Biogen framed the results as the first randomized Phase 2 evidence of a tau-directed therapy showing both biomarker impact and cognitive benefit, and plans to advance diranersen to registrational Phase 3 development.
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.'
Twenty days before the July 23 PCAC vote on 503A bulks list eligibility for BPC-157, the FDA staff briefing documents and independent analyst reviews converge on a consistent picture of the substance's pharmaceutical-development state. Three decades of preclinical research led primarily by Predrag Sikiric's laboratory at the University of Zagreb (200+ published rodent studies covering tendon-to-bone healing, gastric mucosal protection, and vascular regeneration) have not yielded an approved formulation, a validated human dosing regimen, or a completed Phase 2 clinical trial in any indication. Pharmacokinetic data from rat and dog studies show plasma half-life under 30 minutes after IM or IV dosing, though the biological effects (angiogenesis, anti-inflammation, tissue regeneration initiation) persist for weeks to months in animal models. A limited Phase 2 pilot evaluated oral BPC-157 in ulcerative colitis patients with preliminary data suggesting mucosal-healing improvement and clinical-symptom-score benefit, but full results have not been published in peer-reviewed form. The historical evidence base is what PCAC weighs against the July staff briefing conclusion of insufficient evidence for 503A bulks list eligibility. Several biotech companies have publicly signaled 2026 plans to develop BPC-157 analogs with improved pharmacokinetic properties for tendon repair and IBD, but no company has yet advanced an analog into IND-stage development.
MBX Biosciences (Nasdaq: MBX) on June 12 reported full 12-week Phase 2 Avail data and one-year open-label extension results for once-weekly canvuparatide, a precision PTH peptide for chronic hypoparathyroidism. The trial hit its primary endpoint with a 63% responder rate versus 31% on placebo at 12 weeks; the OLE delivered a 79% responder rate at six months and 57% at one year. Patients showed normalized serum calcium, reduced urine calcium excretion, restored bone metabolism, and improved eGFR; 90% of OLE patients remained on study at one year with no new safety signals. A registrational Phase 3 in chronic hypoparathyroidism starts Q3 2026.
Genentech presented Phase 2 CT388-103 data for enicepatide, the once-weekly GLP-1/GIP dual agonist, at the Roche investor event Monday June 8. The 48-week study produced 22.5% placebo-adjusted weight loss in adults with overweight or obesity, with 26% of participants losing more than 30% of body weight and almost 40% reaching at least 25%. Both enicepatide and petrelintide advance into Phase 3, and the planned Phase 2 multi-arm fixed-dose combination of the two starts mid-2026.
Novo Nordisk presented Phase 2 data for zenagamtide (formerly amycretin), its unimolecular GLP-1 and amylin receptor agonist, at ADA 2026 in 262 adults with type 2 diabetes randomized across six subcutaneous doses (0.4 to 40 mg) versus placebo. The 40 mg arm cut HbA1c by 1.71 percentage points and reduced body weight by 14.6% at 36 weeks, with nearly 89% of patients reaching HbA1c below 7%. The study met its primary HbA1c endpoint across all doses; Novo plans Phase 3 in H2 2026 and hosted a same-day R&D investor event.
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.
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.
Viking Therapeutics presented full 13-week Phase 2 VENTURE-Oral data at ECO 2026 May 12 in Istanbul: once-daily oral VK2735 produced statistically significant, dose-dependent mean weight loss up to 12.2% (26.6 lbs) over 13 weeks with placebo-adjusted significance starting at Week 1. The favorable tolerability profile and rapid early onset of effect support Viking's Q4 2026 plan to initiate a Phase 3 trial of the oral formulation following positive FDA feedback. The data complements the Phase 3 VANQUISH-1 subcutaneous program (4,650 patients enrolled November 2025) and VANQUISH-2 in T2D+obesity (~1,000 patients, enrollment completed March 26, 2026). VK2735's dual GLP-1/GIP mechanism puts it in direct comparison with tirzepatide and the next-generation Mounjaro/Zepbound franchise.
Bicycle Therapeutics confirmed in its AACR 2026 update that the company began enrolling patients in a Phase 2 study of nuzefatide pevedotin (BT5528) in adults with recurrent pancreatic ductal adenocarcinoma in March 2026, with the first patient successfully dosed in April. The bicyclic peptide-drug conjugate targets EphA2-expressing tumor cells. Earlier Phase 1/2 data — through a February 9, 2026 cutoff — showed 40% confirmed ORR in EphA2+ urothelial cancer patients on nuzefatide 6.5 mg/m² plus nivolumab, rising to 100% confirmed ORR in MMAE-naïve EphA2+ patients (n=14). The company has identified 8 mg/m² Q2W as the preferred monotherapy dose. The PDAC trial extends Bicycle's footprint into a difficult tumor type where EphA2 imaging readouts at AACR 2026 reinforced target validation.
Rein Therapeutics announced April 29 a clinical update for its Phase 2 RENEW trial of LTI-03 — a peptide therapeutic for idiopathic pulmonary fibrosis (IPF). 8 patients have been enrolled to date, with 2 additional patients expected to be enrolled this week. Enrollment began March 2026 and continues steadily. LTI-03 is one of the few peptide candidates in the IPF space, where current standards of care (pirfenidone, nintedanib) have meaningful tolerability limits. The peptide-based approach is mechanistically distinct, targeting Caveolin-1-related fibrotic pathways.
Boehringer Ingelheim disclosed alongside the survodutide topline that BI 3034701, a first-in-class triple GLP-1/GIP/NPY2 receptor agonist peptide, will enter Phase 2 in mid-2026. The compound completed a randomized placebo-controlled Phase 1 study in healthy volunteers and people with overweight/obesity that demonstrated favorable safety and tolerability and encouraging weight loss. BI 3034701 was developed in collaboration with Gubra, with Boehringer responsible for further development and global commercialization. The novel NPY2 component targets satiety pathways complementary to incretin agonism — a meaningful mechanistic differentiation in the next-gen obesity pipeline.