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Lexeo’s FA Cardiomyopathy Promise | Edwards Mitral Mission
July 18, 2024
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Together with
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“Not a week goes by in my clinic in which someone doesn’t come by and say, ‘My Apple Watch says I have an abnormal heart rhythm.’”
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Northwestern cardiologist Dr. Rod Passman on the Apple Watch’s growing diagnostic role.
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Lexeo Therapeutics gave the 5,000 Americans with Friedreich’s ataxia cardiomyopathy reason for optimism, publishing early results that suggest its LX2006 gene therapy could be able to treat FA cardiomyopathy.
- Friedreich’s ataxia (FA) is a neurodegenerative disorder caused by loss of function mutations in the frataxin gene, although FA patients generally die from FA cardiomyopathy.
- FA is currently only treated by Biogen’s Skyclarys, which slows neurological symptom progression, but doesn’t treat FA cardiomyopathy.
- LX2006 is designed to promote frataxin protein expression and restore mitochondrial function in myocardial cells, potentially treating FA cardiomyopathy.
The analysis combined data from Lexeo’s SUNRISE-FA Phase 1/2 clinical trial and a Weill Cornell Phase 1A trial that were designed to evaluate whether LX2006 could improve FA-related cardiac dysfunction.
Based on interim 6-to-18-month data from eight participants, LX2006 led to improvements to…
- Left ventricular mass index – Of the participants with elevated LVMI at baseline (n=6), four achieved 11.4% average LVMI reductions at 12 months, while two showed 18.3% average reductions at 18 months.
- Left ventricular lateral wall thickness – Participants with LV wall thickening (n=6) achieved a 13.6% average wall thickness reduction at 12 months.
- High-sensitivity Troponin I levels – Participants with elevated hsTnI (n=5) achieved a 53.3% average reduction at 12 months.
- Frataxin levels – All tested patients (n=5) showed increased frataxin levels in their myocardial biopsies following treatment.
LX2006 was also well tolerated in both studies, with no treatment-related serious adverse events and no discontinuations.
- However, LX2006 might have a limited impact on cardiorespiratory fitness, improving participants’ V02 max levels by just 1% at 12 months and 4% after 12 months.
Lexeo will now advance LX2006 to its third dose cohort, with company execs suggesting that a “higher dose cohort could achieve higher protein levels,” and stating that LX2006 could achieve an accelerated approval due to the lack of FA cardiomyopathy treatments.
- They do have a point: the FDA has recently shown support for other gene-based treatments of rare conditions and LX2006 gained FDA Fast Track Designation in April.
However, even with this evidence and precedent, a Wall Street sell-off drove a 36% drop in Lexeo’s stock price since last Friday, due to the limited cardiorespiratory evidence and what some people view as another case of Wall Street “selling on the news.”
The Takeaway
Although Lexeo still has plenty to prove (scientifically and financially), these results suggest that the first Friedreich’s ataxia cardiomyopathy treatment might be on the horizon.
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PRECISE Trial Rewrites the Patient Pathway
HeartFlow’s landmark PRECISE trial found that their precision approach for evaluating people with stable chest pain avoided unnecessary testing and improved care without putting patients at risk of a missed heart disease diagnosis.
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How to Improve Cardiology Workflows and Get More Patient Time
Complex processes and reporting requirements can mean cardiologists spend more time with clinical systems than they do with their patients. See how Merge Hemo and Merge Cardio work together to help you streamline and scale your clinical and data management workflows, so you can have more time in front of your patients.
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Where to Go for Cardio AI?
TeraRecon’s Cardio Suite is a collection of hand-selected, vendor-neutral Cardiology AI algorithms that aid in the analysis and interpretation of echocardiograms and chest CTs. Learn about TeraRecon’s AI offering and how they improve efficiency and accuracy here.
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- Edwards Acquires Innovalve: Edwards Lifesciences continued its push into the mitral valve space, exercising its option to acquire Innovalve Bio Medical for $300M after first investing in the early-stage TMVR company in 2017. With the acquisition, Edwards’ mitral valve portfolio will include Innovalve’s Innostay artificial mitral valve technology, Edwards’ own SAPIEN M3 transfemoral TMVR (European approval expected by late 2025), plus surgical mitral valve technology acquired just last week through its investment in Affluent Medical.
- Wegovy Improves HFpEF Function: JACC published impressive new data showing that semaglutide (Novo Nordisk’s Wegovy) improves obesity-related HFpEF symptoms. In an analysis of data from two STEP-HFpEF trials, patients who took semaglutide for 52 weeks were far more likely to have an improved NYHA functional class than placebo (32.6% vs. 21.5%). In all NYHA class groups, semaglutide patients had improved HF symptoms, fewer physical limitations and reduced weight, as well as less inflammation and congestion.
- LVAD + Pig Kidney Recipient Dies: The first person to receive both a LVAD heart pump and a gene-edited pig kidney has died after three months, leaving a major contribution to xenotransplantation science. Lisa Pisano, a 54-year-old woman with heart and kidney failure, had the pig kidney removed after about seven weeks due to blood flow issues related to the LVAD heart pump. Following the kidney removal, Pisano transitioned back to dialysis and eventually entered hospice care.
- AI Speeds Cardiac MRI: UK researchers developed an AI algorithm that produces much faster 4D cardiac MRI calculations, while matching the predictive power of gold-standard manual analysis. After training and validation with 915 patients’ four-chamber plane CMRIs, the AI-automated left atrial ejection fraction calculations predicted all-cause mortality comparably to manual analysis of short-axis cine scans (HR=0.96 for both techniques). However, the AI scans took just seconds to analyze, compared to 45 minutes for manual analysis.
- Cardurion Adds $260M: Cardurion Pharmaceuticals just landed a massive $260B Series B round to support later-stage clinical trials for its first-in-class PDE9 inhibitor (for heart failure) and CaMKII inhibitor (for catecholaminergic polymorphic ventricular tachycardia), while funding future pipeline-expanding R&D and acquisitions. Cardurion’s lead PDE9 inhibitor, CRD‑750, is in two Phase 2 clinical trials targeting HFrEF and HFpEF, while its lead CaMKII inhibitor, CRD-4730, is in another Phase 2 trial. Cardurion launched through a partnership with Takeda in 2017 and raised $300M through Bain in 2021.
- Deadly Post-PCI Complications: In over 2M PCI cases in the CathPCI registry, complications from the procedure occurred in about 3.5% of patients, but failure to rescue (FTR) in-hospital mortalities occurred with 20% of those complications. FTR rates also rose from 17.1% to 20.1% in 2018-2021, with significant differences between hospitals (OR=1.48). These results suggest that new research to identify practices associated with low FTR could improve PCI outcomes.
- Story Health x Guidehealth: Story Health and Guidehealth announced an alliance that will integrate Story Health’s cardiology-focused virtual care platform and health coaches into the Guidehealth platform. Among providers that work with both companies, Guidehealth’s Healthguides will identify qualified cardiovascular patients and assist with their enrollment with Story Health, then Story Health will directly engage patients to keep their care on track, and Healthguides will ensure providers are kept involved in any care escalations.
- A Case for Lower-Dose Aspirin: A new analysis of the ADAPTABLE study found that an 81 mg daily dose of aspirin works as well for both women and men for secondary ASCVD prevention compared to a 325 mg daily dose. In the study of 15,076 trial participants, 8.1% of females and 7.1% of males experienced the primary event endpoint (all-cause death, hospitalization for MI or stroke) and there were no significant differences between low and high doses for either gender.
- CPT IIIs for 12L ECG AI: AliveCor announced that the AMA has issued three new CPT III reimbursement codes for “algorithmically generated 12-lead ECG from a reduced-lead ECG,” including exams using the company’s newly-cleared Kardia 12L ECG System. Scheduled to go live in January 2025, and the three new codes cover electrocardiograms with interpretation and reporting (0903T), tracing only (0904T), and with interpretation and reporting only (0905T).
- Burnout Improvements: Physician burnout rates dipped below 50% for the first time since the start of the pandemic in 2023, according to an AMA survey of over 12k physicians. About 48% of physicians reported feeling burnout 2023, down from 53% in 2022 and from the 63% all-time high notched in 2021. Last year’s burnout improvement was attributed to initiatives targeting clinical workflows and physician mental health, but “the fight is far from over.”
- Predicting Sudden Cardiac Death: A study out of Finland shows that we might be able to better predict sudden cardiac death (SCD) by evaluating ultra-short-term heart rate fluctuations using detrended fluctuation analysis (DFA). In the study of 2,794 participants, individuals with lower DFA values (minus one standard deviation) had a 2.4-fold higher risk for SCD. The DFA measurements also appear to be a stronger predictive risk tool than conventional heart rate variability testing.
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AI-Powered Home Ultrasound
The recently published CUMIN study shows the technical feasibility of AI-POCUS in the hands of novice nurses and opens new possibilities for redefining how we approach cardiac care. Learn more on this page from Us2.ai.
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Uncover the Brain-Heart Connection
AI might be poised to transform cryptogenic stroke care, but many cardiologists and neurologists still have a lot to learn. Tune-in to this upcoming webinar on July 24th, where Drs. Brett Meyer and Jonathan Hsu will explore how Viz.ai’s post-acute workflow solution, Viz Connect, is being used to accelerate cryptogenic stroke diagnosis and treatment.
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PIA Medical Processes It All
Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.
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- Structured Reporting Cuts Late Charges: Structured reporting is often associated with efficiency improvements, but its ability to reduce errors and improve billing accuracy can deliver benefits across a cardiovascular service line. See how Baystate Medical Center’s transition to structured cardiology reporting with Optum helped them reduce unsigned charges by 79%.
- Track Your Post-Treatment Plaque: Tune-in to this upcoming Cleerly webinar where preventative cardiologist John Osborne, MD, PhD, FACC, FNLA will explore how to use CTA to track plaque progression and identify residual risk post-treatment.
- Experience the future of learning: Medtronic Academy 2.0 is here! Unlock your ultimate destination for structural heart medical education with the newly redesigned Medtronic Academy 2.0. Gain access to expert-led courses, webinars, and a wealth of resources to stay ahead in cardiovascular care. Visit now!
- ECG Data You Can Trust: Noise and artifacts can make automated ECG analysis less reliable than what’s required for the exacting standards of cardiac safety trials. Monebo’s Kinetic Intervals ECG Algorithm provides precise interval measurements between any two points on the ECG waveform, allowing clinicians to utilize data they can trust.
- Enterprise Imaging and the Evolution of Connected Care: Enterprise imaging is the foundation of connected and ultimately human care, in cardiology and beyond. Check out this GE HealthCare report to uncover the next steps in your enterprise imaging journey, and what that means for your patients and physicians.
- Taking AI from Idea to the Clinic: There are few areas of healthcare with more innovation than artificial intelligence, but most of those solutions never make it past being published in a medical journal – providing no additional value to medical care or the solutions’ developers. In this Cardiac Wire Show, Bunkerhill Health CEO Nishith Khandwala discusses Bunkerhill’s unique approach to solving this problem and the impact they are having in cardiology and beyond.
- Circle CVI at SCCT 2024: Ready to enhance your cardiovascular imaging precision and efficiency? Catch up with Circle Cardiovascular Imaging at SCCT 2024 and see how their brand new cvi42 6.1 platform is revolutionizing multi-modality imaging.
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