|
Roche Enters Obesity Arena | Statin Underuse December 7, 2023
|
|
|
|
Together with
|
|
|
|
The already massive GLP-1 obesity drug segment might have gained a major future competitor last week, following Roche’s acquisition of weight loss biotech Carmot Therapeutics.
The acquisition comes with a $2.7B purchase price, and another $400M in potential milestone payments – a notable premium above Carmot’s $385M in funding and three-times the $1B valuation that potential acquirers were reportedly evaluating in September.
That premium is even more notable given that Carmot’s portfolio might not become widely available until the 2030s. However, Roche surely hopes that Carmot’s weight loss pipeline will be worth the wait…
Carmot’s leading candidate is known as CT-388, a Phase 2-ready weekly GLP-1/GIP injection that, like Lilly’s tirzepatide, activates both GIP (affects adipose tissue regulation and storage) and GLP-1 (increases feeling of fullness and decreases gastric emptying) hormone receptors.
- CT-388 is currently targeted for obese and overweight patients with or without diabetes
Carmot’s arguably most-notable candidate is known as CT-996, a daily oral GLP-1 Phase 1 drug for patients with obesity and type 2 diabetes, that could give Roche a differentiated weight loss option compared to the injectables currently on the market.
The biotech also has a once-daily dual GLP-1/GIP injectable (yes, daily) that’s in Phase 2 trials and would treat obese or overweight patients with type 1 diabetes.
Although Roche seems like a weight loss newcomer, it was actually among the first pharma companies to evaluate GLP-1s a decade ago, before halting trials. Now it re-enters a very different GLP-1 segment, with extremely high patient demand and just as high competitive focus from other pharma giants.
That combination is driving what will likely be a wave of similar weight loss drug acquisitions and investments, jumpstarted by….
Although Roche will have some catching up to do in the GLP-1 arena, the company believes that its strengths in diabetes and muscle building drugs could streamline this transition, and could even lead to future combined drugs that drive weight loss without muscle loss.
The Takeaway
In addition to the reminder that it’s a great time to be a GLP-1 biotech, Roche’s acquisition of Carmot Therapeutics is another sign that we’re still in the early innings of the GLP-1 ballgame. By the time the weight loss drug market reaches the $100B-$200B size that everyone is predicting, we’ll almost certainly be talking about a far more diverse set of weight loss players and drug options.
|
|
|
Monebo’s AF ECG Algorithm
Atrial fibrillation is often difficult to characterize with an automated algorithm due to the changing waveform morphology, system, or muscle noise. This is especially true given the size constraints of ambulatory devices to detect AFib. See how Monebo’s Kinetic AF ECG Algorithm overcomes these size limitations without sacrificing accuracy.
|
|
Your Cardiology Data is Valuable. Put it To Work.
See how one major Midwest health system’s decision to implement Merge Cardio transformed physician and staff workflows, improved data entry speed and accuracy, and increased cost savings.
|
|
Evolving Coronary Disease Imaging Pathways
HeartFlow’s PRECISE trial showed that their precision approach for evaluating stable chest pain avoids unnecessary testing and improves care – without risking missed heart disease diagnoses. In this Cardiac Wire Show, HeartFlow’s Chief Medical Officer Dr. Campbell Rogers dives into the PRECISE trial results and its implications for clinical practice.
|
|
- More Proof of Statin Underuse: A study of NHANES data from 1999-2018 highlights the lack of adherence to the 2013 ACC/AHA guidelines that broadened eligibility for primary prevention with statins based on calculated ASCVD risk. In the analysis of almost 22K people, the percentage of eligible patients taking statins rose by 11.6% in 1999–2000 to 32.4% in 2017–2018, but all of those increases happened before 2013–2014. Reasons for underuse include risk scoring complexity and patients’ perceptions about statin side effects.
- Altimmune’s Cardiology Focus: Altimmune released 48-week Phase 2 data for its investigational GLP-1, pemvidutide, revealing solid weight loss numbers, and an increased focus on the drug’s cardiovascular benefits. Patients taking a maximum 2.4 mg dose of pemvidutide lost an average of 15.6%, coming close to current GLP-1s from Novo Nordisk and Lilly (15.6% & 22% at 68 and 72 weeks). Without a weight loss differentiator, Altimmune placed a greater emphasis on pemvidutide’s ability to cut LDL-C (-11.2% vs. -2.5% & -7.1%).
- Pfizer’s Oral GLP-1 Data: Topline Phase 2b results for Pfizer’s oral GLP-1R agonist, danuglipron, revealed decent weight loss numbers (up to -9.5% at 26 weeks, -13% at 32 weeks), but high rates of adverse events (up to 73% had nausea, 47% vomiting) and discontinuations (>50%). Those results will keep this twice-daily formulation from advancing to Phase 3, but Pfizer is also trialing a once-daily formulation of danuglipron, and will apply outcomes from these trials to “inform a potential path forward.”
- Subclinical PA and Cardiovascular Health: A new study challenged the traditional view that primary aldosteronism (PA) is a categorical disease, proposing that subclinical forms of PA exist on a continuum and negatively affect cardiovascular health. In a Canadian cohort (n=1284), subclinical PA, characterized by aldosterone and renin imbalances, was independently associated with increased arterial stiffness and adverse cardiac remodeling. The findings suggest a need to reconsider approaches to PA, emphasizing its potential impact on cardiovascular risk even before hypertension develops.
- Charged Lemonade Deaths: Panera’s highly-caffeinated Charged Lemonade has been blamed for cardiac deaths in two recent lawsuits. The latest case involved a 46 year-old man with a mild intellectual disability and hypertension who suffered a fatal cardiac arrest after consuming three Charged Lemonades, coming a year after a 22 year-old UPenn student with LQT1 suffered a fatal cardiac arrest after consuming a Charged Lemonade. At 390 mg, Charged Lemonade has more caffeine than two Red Bull and Monster cans combined.
- Classifying Stroke Risk: Clinicians might soon be able to leverage a new universal system for classifying stroke risk. The JACC detailed the new Plaque–Reporting and Data System (Plaque-RADS) for quantifying stroke risks based on a patient’s ultrasound, CT, or MRI exams. Developed by a panel of experts, Plaque-RADS outlines approaches for imaging and reporting findings of carotid plaque composition and morphology, with score categories ranging from grade 1 (no plaque) to grade 4 (complicated plaque).
- GE’s AirStrip Alliance: GE HealthCare and Nantworks AirStrip launched a joint commercialization agreement that will make GE the exclusive US distributor for AirStrip’s Cardiology and Patient Monitoring solutions. AirStrip’s mobile and web-connected platform provides one-touch access to cardiac rhythm strips and 12-lead ECGs, STEMI notifications, and care team collaborations, while integrating with GE’s core ECG, cardiac output, and patient monitoring products.
- Albumin-Lowering Powers Finerenone: A post hoc analysis of Phase 3 data for the nonsteroidal MRA finerenone (Bayer’s Kerendia) suggests that albumin-lowering may be driving the drug’s outcomes benefits. In the analysis of 12,512 patients with kidney disease and type 2 diabetes, a 30% reduction in UACR cut kidney-related risk by 64% (organ failure, death, and eGFR measures) and heart-related risks by 26% (CV death, nonfatal MI, nonfatal stroke or HF hospitalization).
- Familial Hypercholesterolemia Gene Tied to Shorter Life: In a study of 58k Icelanders who underwent genome sequencing, researchers found that participants with the LDLR gene that causes familial hypercholesterolemia had six-year shorter lifespans than noncarriers. In comparison, those carrying a cancer gene had 3-year shorter lifespans.
- Incliseran’s Long-term Safety: Analysis of seven clinical trials reaffirms the safety of the PCSK9 sIRNA injectable incliseran (Novartis’ Leqvio) for cholesterol reduction. In the analysis of 3.6K patients on incliseran for up to six years and 1,968 placebo-takers for up to 1.5 years, rates of serious treatment-related adverse events (hepatic, muscle, kidney, liver, and incident diabetes) were similar. Incliseran, which is given twice yearly, was FDA-approved in 2021 and gained approval for primary prevention earlier this year.
- Hospitals Continue to Stabilize: Kaufman Hall’s latest National Hospital Flash Report showed that median hospital operating margins stood at 1.2% through October, marking the third consecutive month at that level. Although year-to-date hospital operating revenue per calendar day was up 6% (vs. expenses per calendar day up 4%), the story that those numbers miss is that the gap between the top- and bottom-performers is widening. The hospitals with the strongest provider and outpatient networks are coming out on top.
|
|
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!
|
|
Incidental CAC Predicts Long-Term Risks
What if you could identify which of your asymptomatic patients have high risks of future cardiac events? Stanford-led researchers used Bunkerhill Health’s Incidental CAC algorithm to do just that, finding that patients with ≥100 incidental CAC scores had a 24% 10-year risk of developing ASCVD and far higher risks of major adverse events.
|
|
- Overcoming Cardiovascular Data Challenges: Aggregating multisource cardiology data is a worthy mission, but it’s often thwarted by confusion and complexity. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, outlines best practices to help you overcome your cardiology data challenges and start leveraging deeper insights.
- A Milestone Study for Cardiac Strain Analysis: Us2.ai’s deep learning algorithm was able to interpret echo AI left ventricular strain images with similar accuracy as conventional measurements. Read all about this milestone study and its implications for echo strain access in EHJ-Digital Health.
- Clearly Transforming Cardiovascular Event Prevention: There’s been plenty of studies evaluating healthcare AI accuracy, but does AI improve patient care? Check out this Cardiac Wire show with Udo Hoffmann, MD, MPH and learn how Cleerly’s new TRANSFORM trial could prove that AI-guided cardiovascular care reduces heart attacks.
- 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.
|
|
|
|
|