Clinical Trials Roundup | 29 May 2026

May 29, 2026 | Clinical Trials

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Written by: Contributor
On behalf of: Life Science Daily News

Apogee Therapeutics’ zumilokibart meets its primary and all secondary endpoints with high statistical significance in the Phase 2 APEX Part B trial for moderate-to-severe atopic dermatitis, TG Therapeutics’ BRIUMVI receives positive Phase 3 ENHANCE data supporting a simplified single-infusion initiation regimen in relapsing multiple sclerosis, Alfasigma’s filgotinib demonstrates sustained improvements across the full spectrum of axial spondyloarthritis in the pivotal Phase 3 OLINGUITO trial, and Eli Lilly’s retatrutide achieves up to 28.3 per cent mean body weight reduction at 80 weeks in the pivotal TRIUMPH-1 Phase 3 trial, the most significant clinical trial results 29 May 2026 has to offer from across the pipeline.

This week delivered a rich cluster of readouts spanning dermatology, neurology, rheumatology, and metabolic disease, reflecting a pipeline that continues to advance across both rare and high-prevalence conditions. The atopic dermatitis data represent a potential turning point in the inflammatory disease space, with clinical results positioning a new entrant to challenge an established class of approved therapies. Elsewhere, a pivotal obesity programme has now crossed a threshold that rivals outcomes historically associated with bariatric surgery, while a delivery innovation in multiple sclerosis and a new dataset from rheumatology’s most closely watched annual congress round out a consequential seven days. Here, Life Science Daily News brings you the most significant clinical trial results 29 May 2026.

Apogee Therapeutics’ Zumilokibart Meets All Endpoints in Phase 2 APEX Part B Trial for Atopic Dermatitis

Apogee Therapeutics announced on 27 May 2026 positive 16-week data from Part B of the Phase 2 APEX clinical trial of zumilokibart (APG777), an investigational anti-interleukin-13 (IL-13) monoclonal antibody, in 346 adults with moderate-to-severe atopic dermatitis (AD). The trial met its primary and all secondary endpoints with high statistical significance. In the mid-dose arm, 65.9 per cent of patients achieved EASI-75 at week 16, representing a placebo-adjusted response of 41.9 per cent. All three dose groups outperformed placebo across the primary endpoint and all key secondary measures, including EASI-90, Validated Investigator’s Global Assessment (IGA) 0/1, and patient-reported outcome scores. Zumilokibart was well tolerated, with a safety profile consistent with the known class characteristics of IL-13 inhibitors. The most common treatment-emergent adverse events were nasopharyngitis, headache, and non-infective conjunctivitis. The pooled conjunctivitis rate at the planned Phase 3 mid-dose was 10.6%, lower than the high dose (20.7%) and low dose (15.1%), a finding the company notes is consistent with the class profile and will be monitored in the Phase 3 programme.

Based on the dose optimisation results, Apogee plans to advance the mid-dose into three Phase 3 trials in moderate-to-severe AD in the second half of 2026, pending regulatory interactions: ADventure 1, ADventure 2, and ADventure TCS, each expected to enrol approximately 400 patients across 16-week induction and 52-week maintenance periods. The company simultaneously disclosed plans to begin a Phase 2a study in eosinophilic esophagitis (EoE) in the second half of 2026 and a Phase 2b study in moderate-to-severe asthma in the first half of 2027, supporting zumilokibart’s potential as a pipeline-in-a-product candidate across multiple type 2 inflammatory diseases. Apogee also announced a $1.3 billion strategic financing collaboration with Blackstone Life Sciences, expected to fund development through potential commercialisation. The APEX Part A 52-week maintenance data, previously reported, demonstrated continued improvement in disease control over time with dosing as infrequent as every three to six months, a potential convenience advantage over current approved anti-IL-13 and anti-IL-4/13 therapies, which typically require fortnightly subcutaneous dosing.

TG Therapeutics’ BRIUMVI Meets Phase 3 Primary Endpoint in ENHANCE Trial, Supporting Simplified Initiation Regimen in Relapsing Multiple Sclerosis

TG Therapeutics announced on 27 May 2026 positive topline results from the Phase 3 ENHANCE trial, a randomised, double-blind study evaluating a consolidated single-infusion initiation regimen for BRIUMVI® (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved two-infusion initiation regimen (150 mg on Day 1 and 450 mg on Day 15) and a single consolidated infusion of 600 mg on Day 1, eliminating the need for the Day 15 clinic visit. The safety and tolerability profile of the consolidated regimen was consistent with the established BRIUMVI safety profile, with no new safety signals identified.

BRIUMVI is a glycoengineered anti-CD20 monoclonal antibody approved by the FDA in December 2022 for adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is differentiated from other anti-CD20 therapies by its design to maximise antibody-dependent cellular cytotoxicity (ADCC) while minimising complement-dependent cytotoxicity (CDC), enabling effective B-cell depletion at low doses. The ENHANCE trial was designed to support a supplemental biologics licence application (sBLA), which TG Therapeutics has targeted for the second half of 2026. If approved, the consolidated regimen would meaningfully reduce the treatment burden for patients initiating therapy, removing the requirement for a second infusion visit 15 days after the first, and potentially supporting broader access and adherence in clinical practice. BRIUMVI is currently administered as maintenance infusions every six months following the initiation regimen.

Alfasigma’s Filgotinib Demonstrates Sustained Improvements Across Full Spectrum of Axial Spondyloarthritis in Phase 3 OLINGUITO Trial

Alfasigma presented on 26 May 2026 the first data from the Phase 3 OLINGUITO clinical trial (NCT05785611) evaluating filgotinib, an oral, once-daily JAK1 preferential inhibitor, in patients with active axial spondyloarthritis (axSpA), at the European Alliance of Associations for Rheumatology (EULAR) 2026 congress in Barcelona. The trial comprised two international, randomised, double-blind, placebo-controlled studies evaluating filgotinib 200 mg once daily in both radiographic axSpA (r-axSpA, also known as ankylosing spondylitis) and non-radiographic axSpA (nr-axSpA). In both populations, a significantly greater proportion of patients receiving filgotinib achieved the prespecified primary endpoint of ASAS40 (a 40 per cent or greater improvement in axial spondyloarthritis assessment criteria) at week 16 compared with placebo, with improvements observed as early as week 1.

Improvements in signs and symptoms were maintained over 52 weeks of treatment. Of those achieving ASAS40 at week 16, 84.6 per cent of r-axSpA patients and 78.0 per cent of nr-axSpA patients maintained their response to week 52. Additionally, approximately 40 to 44 per cent of filgotinib-treated patients achieved either Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease or low disease activity at week 16, with the proportion rising to 58 to 61 per cent by week 52, consistent irrespective of prior biologic DMARD treatment. No new safety signals were observed over the 52-week treatment period, with the safety profile consistent with the known profile of filgotinib. The full oral presentation of the primary OLINGUITO data is scheduled for the EULAR 2026 scientific programme on 4 June 2026. Filgotinib is currently approved as Jyseleca® in the European Union, United Kingdom, Japan, and several other markets for moderate-to-severe active rheumatoid arthritis; the OLINGUITO data form the basis for a potential new indication in axSpA.

Eli Lilly’s Retatrutide Delivers Up to 28.3 Per Cent Mean Weight Loss at 80 Weeks in Pivotal TRIUMPH-1 Phase 3 Obesity Trial

This story was announced on 21 May 2026, within this edition’s coverage window but after the preceding roundup had closed. Given its clinical and commercial significance, Life Science Daily News is covering it here.

Eli Lilly announced on 21 May 2026 positive topline results from TRIUMPH-1, the pivotal Phase 3 clinical trial evaluating retatrutide, an investigational first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist, in adults with obesity or overweight and at least one weight-related comorbidity, without type 2 diabetes. The trial enrolled 2,339 participants across three dose levels (4 mg, 9 mg, and 12 mg once weekly) and placebo in a randomised, double-blind, placebo-controlled design over 80 weeks. All three doses met the primary and key secondary endpoints for statistically significant and clinically meaningful weight loss. Participants on the 12 mg dose achieved a mean body weight reduction of 28.3 per cent (70.3 lbs) at 80 weeks, with 45.3 per cent achieving 30 per cent or greater weight loss, a threshold historically associated with bariatric surgery. The 4 mg dose achieved 19.0 per cent (47.2 lbs) mean weight loss at 80 weeks with a lower discontinuation rate due to adverse events than placebo. In a pre-specified blinded extension in participants with a baseline BMI of 35 kg/m² or higher who completed the main trial, those on the 12 mg pathway achieved a mean 30.3 per cent (85.0 lbs) body weight reduction at 104 weeks.

The adverse event profile was broadly consistent with incretin-class therapies, with gastrointestinal effects including nausea, vomiting, and diarrhoea among the most commonly reported. Retatrutide’s triple agonist mechanism targets GIP, GLP-1, and glucagon receptors simultaneously, offering a differentiated pharmacological profile compared with dual GIP/GLP-1 agonists such as tirzepatide. Full data from TRIUMPH-1 are expected to be presented at the 86th American Diabetes Association Scientific Sessions. Additional Phase 3 results from the broader TRIUMPH programme are expected later in 2026, including TRIUMPH-2 (in adults with obesity or overweight and type 2 diabetes) and TRIUMPH-3 (in adults with obesity or overweight and established cardiovascular disease). If subsequent trials are successful, Lilly has indicated it plans to pursue FDA submission as early as the end of 2026.

Looking Ahead

This week’s clinical trial results 29 May 2026 illustrate the sustained pace of development across some of the largest and most competitive therapeutic markets in medicine. Zumilokibart’s Phase 2 performance in atopic dermatitis raises the prospect of a new standard of care in a field already shaped by several blockbuster biologics, while a financing collaboration of $1.3 billion signals the commercial confidence now attached to the programme. The simplified BRIUMVI initiation regimen, if approved, offers a practical quality-of-life improvement for patients with relapsing MS embarking on what is otherwise a well-established therapy. The OLINGUITO results extend the evidence base for oral targeted therapy in axial spondyloarthritis, a large patient population that remains underserved by existing options in some geographic markets. And retatrutide’s pivotal Phase 3 data, producing weight loss comparable to bariatric surgery in a once-weekly injection, mark another significant escalation in the metabolic disease arms race. Life Science Daily News will continue to bring you accurate, timely coverage of the clinical trial results 29 May 2026 that matter most across the global life sciences pipeline.

 

This clinical trials roundup is produced by the Life Science Daily News editorial team. All stories are selected and written independently.

    References:
    1. Apogee Therapeutics, 27 May 2026. Positive 16-Week Part B Induction Dose Optimization Results from Phase 2 APEX Trial of Zumilokibart in Moderate-to-Severe Atopic Dermatitis https://www.globenewswire.com/news-release/2026/05/27/3301719/0/en/Apogee-Therapeutics-Announces-Positive-16-Week-Part-B-Induction-Dose-Optimization-Results-from-Phase-2-APEX-Trial-of-Zumilokibart-in-Moderate-to-Severe-Atopic-Dermatitis.html
    2. TG Therapeutics, 27 May 2026. Positive Topline Results from Phase 3 ENHANCE Trial https://www.globenewswire.com/news-release/2026/05/27/3301820/8790/en/TG-Therapeutics-Announces-Positive-Topline-Results-from-Phase-3-ENHANCE-Trial.html
    3. Alfasigma S.p.A., 26 May 2026. Alfasigma Presents First Data on Filgotinib from the Phase 3 OLINGUITO Trial in Axial Spondyloarthritis at EULAR 2026 https://www.businesswire.com/news/home/20260526373154/en/Alfasigma-presents-first-data-on-filgotinib-from-the-Phase-3-OLINGUITO-trial-in-axial-spondyloarthritis-at-EULAR-2026
    4. Eli Lilly and Company, 21 May 2026. Lilly's Triple Agonist, Retatrutide, Delivered Powerful Weight Loss in Pivotal Phase 3 Obesity Trial https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html

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