Pro Vice Provost (International Health) at University College London (UCL), and Vice Dean (International) to the Faculty of Medical Sciences

Initial data from a phase 1/2 trial of BEAM-302, a first-in-human in vivo base-editing therapy for 

 (AATD), showed a single dose durably raised functional alpha-1 antitrypsin (AAT) above the protective threshold in patients with AATD-associated lung disease, according to John R. Hurst, MD, PhD, professor of respiratory medicine at University College London. Hurst discussed the findings, presented as a poster at the 

European Respiratory Society (ERS) International Congress, held in Barcelona from September 5-9

. BEAM-302 uses a guide RNA, adenine base editor, and nickase delivered by lipid nanoparticle to directly correct the disease-causing SERPINA1 mutation in the liver, rather than relying on a viral vector or replacing protein exogenously.

BEAM-302 Base Editing Sustains Protective AAT, With John Hurst, MBBS, PhD

As of the March 14, 2026, data cutoff, 21 patients with AATD-associated lung disease had received single ascending doses of BEAM-302 (15, 30, 60, or 75 mg), with median follow-up ranging from about 7.7 to 17.7 months across dose groups.

 Hurst said a single dose at 60 mg or higher produced sustained total AAT concentrations above the 11-µM threshold associated with protection from emphysema, a threshold established from the natural history of heterozygous carriers of the deficiency allele who do not have significantly elevated lung disease risk.

 The same dose range produced roughly an 80% reduction in circulating mutant Z-AAT. 

“For people living with AATD, I don’t think I’ve ever been more optimistic that the future is going to look very different than it does now,” Hurst said.

On safety, Hurst said the profile so far has been consistent with other lipid nanoparticle-delivered therapies: about 40% of patients had grade 1 or 2 infusion-related reactions, generally managed with slower infusion rates or simple interventions like acetaminophen, alongside transient, asymptomatic grade 1 liver enzyme elevations in the first 28 days. No serious treatment-related adverse events had been reported, and Hurst said durability data extending to 18 months for safety and 12 months for efficacy at the 60-mg dose showed no signal of waning response, though longer follow-up is still needed before durability claims can be considered definitive.

Hurst highlighted 2 additional findings from the accompanying poster. First, treated patients showed reduced levels of polymerized Z-AAT protein, a proinflammatory species implicated in AATD-related lung damage, which he said had not previously been demonstrated with any AATD intervention. Second, in a single patient who developed a respiratory infection during follow-up, blood total AAT rose from a steady-state mean of about 14 µM to roughly 23 µM during the infection before settling near 19 µM by month 9, suggesting the corrected gene preserved normal physiologic upregulation of AAT during acute stress rather than producing only a fixed baseline level. Hurst said future trials will need to incorporate clinical and imaging endpoints, including spirometry, gas transfer, CT-based lung density, symptoms, and exacerbation rates, to demonstrate benefit beyond the AAT biomarker itself.

Hurst JR, van 't Wout EFA, Ashdown T, et al. First-in-human in vivo gene editing for severe alpha-1 antitrypsin deficiency (AATD): initial data from the Phase 1/2 study of BEAM-302. Poster presented at: European Respiratory Society (ERS) International Congress; September 5-9, 2026; Barcelona, Spain.

Stolk J. Alpha-1 antitrypsin deficiency: an update. 

Articles

Initial phase 1/2 data for BEAM-302, an in vivo adenine base-editing therapy targeting SERPINA1 in hepatocytes via lipid nanoparticles, demonstrate durable biomarker correction after a single dose in AATD-associated lung disease. Among 21 treated patients, doses ≥60 mg sustained total AAT above the 11 µM protective threshold with substantial depletion of circulating mutant Z-AAT. Safety has resembled other LNP platforms, dominated by mild infusion reactions and transient low-grade transaminase elevations, without serious treatment-related events to date.

Hurst discusses data showing durably raised protective AAT levels in patients with alpha-1 antitrypsin deficiency.

Alpha-1 antitrypsin deficiency

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Rahul Aggarwal, MD, MBA, is a cardiology fellow at Harvard Medical School.

Despite widespread implementation of guideline-directed medical therapy (GDMT) and percutaneous coronary intervention (PCI), residual 

ST-elevation myocardial infarction (STEMI)

Heart Failure Risk Lingers After ST-Elevation Myocardial Infarction

European Society of Cardiology (ESC) Congress 2026

 in Munich, Germany, by Rahul Aggarwal, MD, MBA, a cardiology fellow at Harvard Medical School, this retrospective cohort study analyzed adults with STEMI undergoing PCI to determine the degree of lingering HF risk following treatment and identify high-risk subgroups for targeted intervention.

“We do a lot of trials that study heart failure hospitalizations specifically, but what we’re seeing is that there are still a lot of visits for heart failure that are happening in the outpatient setting as well,” Aggarwal told 

 in an exclusive interview. “This represents an area where we really need to have intervention and good therapies to help reduce these rates.”

These findings contradict existing data from earlier studies investigating the correlation between STEMI and HF risk. In 2017, a study conducted in the Netherlands found very low long-term contemporary incidence of HF following first STEMI. This study included a much smaller cohort and ultimately concluded that, despite increased risk with higher creatine kinase and left anterior descending artery culprit lesion, HF was not common following first STEMI.

Aggarwal and colleagues utilized Optum Market Clarity linked electronic health record and claims data between July 2021 and December 2023 to identify patients with STEMI undergoing PCI. The team assessed HF and mortality outcomes both overall and in clinical subgroups, including anterior STEMI, anterior STEMI LAD/left main culprit vessel, and patients without prior HF or MI.

A total of 63,276 patients with STEMI were included in the study, with a median age of 64.2 years. Cardiovascular risk burden was high among these patients, with 60.9% having hypertension, 32.5% having type 2 diabetes, and 6.9% with a prior myocardial infarction. After 1 year, HF hospitalization had occurred in 8.21% of patients (95% CI, 8-8.43) while all-cause mortality occurred in 8.5% (95% CI, 8.29-8.72).

Independent predictors of hospitalization included prior HF (HR, 1.96; 95% CI, 1.82-2.1), prior MI (HR, 1.16; 95% CI, 1.07-1.25), anterior STEMI (HR, 1.54; 95% CI, 1.47-1.63), and chronic kidney disease (HR, 1.5; 95% CI, 1.4-1.6). Mortality was strongly associated with cardiogenic shock (HR, 2.95; 95% CI, 2.77-3.14), cardiac arrest (HR, 2.92; 95% CI, 2.71-3.14), and anterior STEMI (HR, 1.09; 95% CI, 1.04-1.15).

Aggarwal and colleagues found that patients with anterior STEMI represented a higher-risk group, with greater risk for hospitalization (10.36% [95% CI, 9.98-10.74] vs. 8.21%; relative increase 26%) and mortality (9.54% [95% CI, 9.18-9.91] vs. 8.5%; relative increase 12%). Additionally, in-hospital complications were more common among patients with anterior STEMI, including HF (58.9% vs 44.5%) and cardiogenic shock (17.7% vs 14.5%). HF outpatient encounters were also more frequent, occurring in 37.5% of all patients and 50.3% of anterior STEMI patients within 1 year.

Ultimately, Aggarwal and colleagues concluded that patients with prior STEMI exhibit substantial residual risk of HF, particularly among those with anterior MI. The study highlights the need for risk-guided surveillance strategies to mitigate downstream HF and mortality.

“I think being able to identify those patients who are not fully at clinical phenotypes or don’t have congestion yet, for example, but have multiple of these risk factors that put them in a pre-heart-failure stage or a pre-stage to having clinical symptoms, and appropriately giving guideline-directed medical therapy at that time can reduce the rates of having downstream end outcomes such as mortality or heart failure hospitalizations,” Aggarwal said.

Editors’ Note: Aggarwal reports disclosures with Bristol Myers Squibb, Pfizer, Novartis, and Lexicon.

Aggarwal R, Kim R, Schroeder M, et al. Contemporary heart failure and mortality burden after STEMI: insights from a real-world cohort. Presented at the European Society of Cardiology (ESC) Congress 2026, Munich, Germany. August 28-31, 2026.

Gho JMIH, Postema PG, Conijn M, et al. Heart failure following STEMI: a contemporary cohort study of incidence and prognostic factors. Open Heart. 2017;4(2):e000551. Published 2017 Dec 22. 

Videos

Rahul Aggarwal, MD, MBA, shares the results of his retrospective cohort study investigating the residual risk of heart failure after patients with prior MI.

Cardiology

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Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Structural Heart Disease

Professor of Respiratory Medicine at Université Paris-Saclay

The platelet-derived growth factor (PDGF) pathway remains a legitimate target in pulmonary arterial hypertension (PAH) despite a difficult history with oral tyrosine kinase inhibitors, according to Olivier Sitbon, MD, PhD, professor of respiratory medicine at Université Paris-Saclay and consultant at the French Pulmonary Hypertension Referral Center, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.

PDGF Pathway in PAH: Setbacks and Promise, With Olivier Sitbon, MD, PhD

, Sitbon traced 2 decades of PDGF-directed drug development in PAH, from early kinase inhibitors through the antibody and prodrug programs now in testing. Earlier this year, 

another PDGF-pathway kinase inhibitor, seralutinib, missed its primary end point in a phase 3 trial

"PDGF is a growth factor. It's involved in the pathophysiology, involved in many cells that contribute to the development of lesions we see in PAH, in particular smooth muscle cells, endothelial cells, progenitors, also immune cells. That's a real target," Sitbon said.

Sorafenib, the first PDGF-pathway agent tested in PAH, was abandoned early because of excessive toxicity. Imatinib (Gleevec) followed, producing major hemodynamic improvement in a phase 2 trial that led to the phase 3 IMPRES trial.

IMPRES showed imatinib improved 6-minute walk distance versus placebo, but adverse events, including gastrointestinal toxicity, facial edema, and subdural hematoma, drove more discontinuations in the imatinib arm than placebo. The drug's PAH development program was ultimately discontinued.

An inhaled dry-powder formulation, AV-101, was tested against placebo across 3 doses in the phase 2b/3 IMPAHCT trial.

 Results were neutral on the primary end point of pulmonary vascular resistance, and the phase 3 portion was halted.

A newer approach uses IKT-001, an oral prodrug of imatinib designed to release the drug systemically while limiting direct gastrointestinal exposure. Inhibikase Therapeutics is testing 300-mg and 500-mg once-daily doses against placebo in the adaptive phase 3 IMPROVE-PAH trial, which began enrolling in 2026.

Sitbon also pointed to a nontyrosine kinase inhibitor strategy: REGN13335, an anti-PDGF-B monoclonal antibody from Regeneron, is being tested against placebo in the phase 2 ILLUMINATE trial in adults with PAH.

 He said its more selective mechanism could avoid the safety issues seen with tyrosine kinase inhibitors.

1. Hoeper MM, Barst RJ, Bourge RC, et al. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013;127(10):1128-1138.

2. Hill NS, Gillies H, Chakinala MM, et al. Phase 2b trial of inhaled imatinib for treatment of pulmonary arterial hypertension. Am J Respir Crit Care Med. 2026;212(4):802-812.

3. Inhibikase Therapeutics. Inhibikase Therapeutics Advancing IKT-001 to Global Phase 3 Study in Pulmonary Arterial Hypertension. Press release. November 20, 2025.

4. ClinicalTrials.gov. Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (ILLUMINATE). NCT07318597.

Olivier Sitbon, MD, PhD, reviews PDGF-targeted therapy in PAH, from imatinib's IMPRES trial to new prodrug and antibody approaches.

Jawad Butt, MD, PhD, is a research fellow in the department of cardiology at Copenhagen University Hospital and the University of Glasgow.

A prespecified meta-analysis of three placebo-controlled trials found hydralazine plus isosorbide dinitrate (H-ISDN) reduced all-cause and cardiovascular death in patients with heart failure with reduced ejection fraction (HFrEF). Jawad Haider Butt, MD, PhD, presented the pooled findings, drawn from 2101 patients across V-HeFT I, A-HeFT, and the newly completed H-HeFT trial, at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany.¹

H-ISDN cut the risk of all-cause death by 29%, though the effect on heart failure hospitalization proved less consistent.³

H-ISDN Meta-Analysis Cuts Mortality Risk in Heart Failure

Guidelines currently reserve H-ISDN for patients unable to tolerate an ACE inhibitor, ARB, or ARNI, and for patients who self-identify as Black with NYHA class III or IV symptoms on foundational therapy. This guidance traces to the 2004 A-HeFT trial, which showed a 43% mortality reduction with H-ISDN added to standard therapy at the time.² The H-HeFT trial set out to test whether similar benefit extended to a broader, contemporary population.

Guideline recommendations for H-ISDN stem from small, older trials individually underpowered for mortality. The meta-analysis sought to strengthen the evidence base by combining all available placebo-controlled data in HFrEF.

H-ISDN Meta-Analysis Design and Mortality Findings

Butt and colleagues combined trial-level data from V-HeFT I (1986), A-HeFT (2004), and H-HeFT to answer a question neither trial alone was powered to resolve: does H-ISDN reduce mortality? In the primary fixed-effect analysis, H-ISDN was associated with reduced all-cause death (HR, 0.71; 95% CI, 0.58-0.87) and cardiovascular death (HR, 0.65; 95% CI, 0.47-0.90) compared with placebo.³ A reduction in heart failure hospitalizations also emerged, but significant between-trial heterogeneity prompted a sensitivity analysis using a random-effects model.

Under the random-effects model, mortality estimates held steady, but the hospitalization benefit lost statistical significance.³ Butt noted 2 of the 3 trials were underpowered for mortality alone, part of the rationale for pooling the data. The meta-analysis was prespecified before H-HeFT's primary results were unblinded.

H-HeFT Trial Results and Clinical Implications

H-HeFT, presented separately by principal investigator Lars Køber, MD, enrolled 592 patients with HFrEF who did not self-identify as Black, all receiving foundational therapy. Over up to 7 years of follow-up, H-ISDN failed to reduce the composite primary endpoint of death, worsening heart failure, urgent intravenous or metolazone therapy, transplantation, or ventricular assist device implantation compared with placebo.¹

Event rates were 8.6 vs 9.3 per 100 patient-years (HR, 0.90; 95% CI, 0.67-1.21). All-cause death occurred in 19.4% of the H-ISDN group versus 24.2% of the placebo group (HR, 0.72; 95% CI, 0.51-1.02), a gap not statistically significant on its own.¹

Treatment discontinuation rates were high in H-HeFT, a factor that may have diluted the drug's apparent effect.¹ Because the primary endpoint in H-HeFT was neutral, Butt considers the meta-analysis findings hypothesis-generating rather than practice-changing.

Køber said a new randomized trial will be needed to establish whether H-ISDN truly reduces mortality.¹ Butt agreed such a trial remains justified, given the residual risk for death and hospitalization left by current four-pillar HFrEF therapy, though he noted the absence of commercial sponsorship makes investigator-initiated trials difficult to mount.

Editors’ Note: Butt reports disclosures with AstraZeneca, Bayer, and Novartis.

European Society of Cardiology. No demonstration of benefit with hydralazine plus isosorbide dinitrate in heart failure. Published August 30, 2026. Accessed September 4, 2026.

Taylor AL, Ziesche S, Yancy C, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004;351:2049-2057.

Butt JH. H-ISDN Meta-Analysis: Hydralazine-Isosorbide Dinitrate in HFrEF. Presented at: ESC Congress 2026; August 30, 2026; Munich, Germany.

Pooled data from 3 trials show H-ISDN cuts all-cause and cardiovascular death in HFrEF, though heterogeneity limits clinical impact.

H-ISDN Meta-Analysis Lowers Mortality in Heart Failure, With Jawad Butt, MD, PhD

Investigator, BC Children's Hospital
Head, Division of Respiratory Medicine, Department of Pediatrics, University of British Columbia
Professor, Department of Pediatrics, Faculty of Medicine, University of British Columbia

A win-ratio analysis of the phase 3 VOYAGE trial found children with moderate-to-severe type 2 

 were more than twice as likely to achieve favorable outcomes on add-on dupilumab than placebo, regardless of whether they started on medium- or high-dose inhaled corticosteroids (ICS), according to Sharon Dell, MD, FRCPC, professor and head of the Division of Respiratory Medicine in the Department of Pediatrics at the University of British Columbia. 

Dupilumab Scores on Win-Ratio Analysis in Pediatric Asthma: Sharon Dell, MD

Dell discussed the findings, presented as a poster at the 

. Win-ratio analysis, still uncommon in pediatric asthma trials, compares each treated patient against each placebo patient across a hierarchy of outcomes, moving to the next-ranked outcome only when a pair ties; Dell said the method has already supported at least 2 FDA drug approvals and is more established in cardiovascular research, where it allowed rare outcomes like death to be weighed alongside more common ones.

The analysis ranked exacerbation freedom over 52 weeks as the top-priority outcome, followed by fewer exacerbations, normal lung function at week 52, and achieved asthma control (Asthma Control Questionnaire-5 score under 1.5). Dell said exacerbation freedom was placed first because exacerbations are the primary endpoint used to approve biologic therapies in asthma, while lung function was prioritized above symptom control specifically for children, since normal childhood lung function is associated with better respiratory outcomes in adulthood. Among children on high-dose ICS at baseline, dupilumab won 57.2% of pairs versus 26.7% for placebo, for an overall win ratio of 2.14 (95% CI, 1.35-3.40), with dupilumab prevailing in 68.2% of non-tied pairs.

 Among children on medium-dose ICS, the win ratio was 2.31 (95% CI, 1.45-3.68), with dupilumab winning 69.8% of non-tied pairs.

“The win ratio analysis translates really nicely into clinical messaging, because it tells us that, overall, you're more than twice as likely to have better asthma outcomes if you take dupilumab compared to placebo,” Dell said.

Because outcomes were similar across ICS strata, Dell said the findings raise a practical question about treatment timing. In Canada, children must remain on high-dose ICS for at least 6 months before qualifying for biologic therapy, but she noted this analysis suggests similar benefit even from a medium-dose ICS starting point. “It does beg the question of are we starting too late,” she said, adding that children may be more sensitive to the effects of prolonged high-dose ICS than adults. VOYAGE previously showed that by week 52, 46% of children receiving dupilumab achieved on-treatment clinical remission.

Dell S, Guilbert TW, Gappa M, Xia C, Ledanois O, Gall R, Bacharier LB. Win ratio analysis of dupilumab achieving on-treatment clinical remission in children with moderate-to-severe type 2 asthma. Poster presented at: European Respiratory Society (ERS) International Congress; September 5-9, 2026; Barcelona, Spain.

Bacharier LB, Guilbert TW, Zangrilli J, et al. Dupilumab in children with uncontrolled moderate-to-severe asthma. 

 2021;385(24):2230-2240. doi:10.1056/NEJMoa2106567

Dell discusses an analysis of VOYAGE showing dupilumab more than doubled the odds of favorable asthma outcomes in children, regardless of baseline ICS dose.

Asthma

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Diagnostic delays in EoE can have consequences beyond persistent symptoms. The panel explores how earlier recognition and collaborative care may help address progressive esophageal remodeling and reduce long-term disease burden.

Video Series

Addressing Diagnostic Delays in EoE

Saakshi Khattri, MD, is a board certified Dermatologist, Rheumatologist and Internist and one of only a handful of triple board-certified physicians across the US.

In "The Next Five Years in Psoriasis: Remission, Access, and Combinations," the panel looks ahead to the advances and the unfinished work of the coming years.

The Next Five Years in Psoriasis: Remission, Access, and Combinations

Early EoE diagnosis is about more than relieving symptoms today. The panel explores how timely recognition and treatment of inflammation may help limit progressive structural changes and protect long-term esophageal health.

The Importance of Early Diagnosis in EoE

Castro, of University of Kansas discusses interim phase 1b data showing rapid, durable suppression in patients with mild to moderate asthma.

Zumilokibart Rapidly Suppresses FeNO in Phase 1b Asthma Data: Mario Castro, MD

John Oppenheimer, MD, clinical professor of medicine at Rutgers New Jersey Medical School and allergist at Pulmonary and Allergy Associates of New Jersey

At ERS 2026, John Oppenheimer, MD, discusses how PERFORM supports earlier escalation in patients with uncontrolled, infrequently exacerbating asthma.

Q&A: PERFORM Data Support Triple Therapy in Milder Uncontrolled Asthma

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

ADVANCE Outcomes at ERS 2026 demonstrated improved odds of improvement and reduced odds of worsening.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Ralinepag Improves Clinical Outcomes in Contemporary PAH Population

Charalambos Antoniades, MD, PhD, is the director of the Acute Multidisciplinary Imaging & Interventional Centre and BHF chair of cardiovascular medicine at the University of Oxford and founder and chief scientific officer at Caristo Diagnostics.

Charalambos Antoniades, MD, PhD, discusses the recent trial investigating an AI-powered stroke and atrial fibrillation predictor.

Stroke

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Arrhythmia

ORFAN-MAESTRIA: AI Predicts Cardioembolic Stroke, Atrial Fibrillation from CT Scans

The oral RARβ/γ agonist improved FVC and reduced fibrotic biomarkers over 12 weeks in a phase 2a trial presented at the ERS Congress 2026.

Pulmonary Fibrosis

GRI-0621 Improves FVC, Reduces Fibrotic Biomarkers in IPF

A COPD genetic risk score was linked to reduced lung function growth from birth to age 6, but only in children with high air pollution exposure.

COPD

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Childhood Pollution Exposure May Trigger COPD Polygenic Risk

Kyle Hogarth, MD, professor of medicine and medical director of the Pulmonary Rehabilitation Program and director of the Alpha-1 Antitrypsin Deficiency Clinical Resource Center at University of Chicago Medicine. 

Kyle Hogarth, MD, urges physicians to complete Alpha-1 testing during every COPD or asthma workup, warning that skipped tests delay diagnosis.

Latest News

BEAM-302 Base Editing Sustains Protective AAT, With John Hurst, MBBS, PhD

Heart Failure Risk Lingers After ST-Elevation Myocardial Infarction

PDGF Pathway in PAH: Setbacks and Promise, With Olivier Sitbon, MD, PhD

H-ISDN Meta-Analysis Lowers Mortality in Heart Failure, With Jawad Butt, MD, PhD

Dupilumab Scores on Win-Ratio Analysis in Pediatric Asthma: Sharon Dell, MD