Latest news with #ARO-INHBE
Canada News.Net
22-06-2025
- Business
- Canada News.Net
Fat loss, not strength loss: inside pharma's latest race
WASHINGTON, D.C.: As the global weight-loss market explodes, drugmakers are now racing to solve a less visible problem: protecting muscle mass. Existing treatments like Novo Nordisk's Wegovy and Eli Lilly's Zepbound have proven effective at helping people shed pounds, but not all the weight lost is fat. Muscle loss, especially in older patients, can raise the risk of falls and lower physical strength, spurring a wave of new drug development. Here's a look at the key players and their experimental therapies designed to combat fat while preserving or even boosting lean muscle: Eli Lilly Lilly spent nearly $2 billion in 2023 to acquire Versanis Bio's bimagrumab, a treatment that inhibits the myostatin protein to help protect muscle. The company is testing the drug alone and with Novo's Wegovy in a mid-stage trial. It also partnered with China's Laekna to develop a similar drug. Regeneron Regeneron is evaluating trevogrumab—a similar myostatin-targeting antibody—in combination with Wegovy and another drug, garetosmab. The three-part study includes both healthy and obese participants and tracks changes in weight, fat, waist size, body composition, and thigh muscle volume. It is expected to wrap up next year. Scholar Rock Scholar Rock's apitegromab, also a myostatin inhibitor, is being tested with Lilly's Zepbound. A mid-stage study showed the combination helped preserve more lean mass than Zepbound alone. Roche Roche is studying RG6237, an anti-latent myostatin, in overweight individuals. Starting this year, it plans to combine this drug with its own GLP-1 candidate, CT-388, in a mid-stage trial. Biohaven Biohaven's taldefgrobep alfa recently fell short in treating spinal muscular atrophy, but in an early-stage obesity trial, it reduced fat mass and increased lean mass and bone density. A mid-stage obesity trial is planned. Keros Pharma Keros' KER-065 targets both myostatin and activin A. In preclinical trials, it boosted lean mass and cut fat in obese mice. A first-stage trial in obese men is underway, with results expected in Q1 2025. Northstrive Biosciences Northstrive, formerly Elevai Labs, bought two myostatin-targeting drugs (EL-22 and EL-32) from South Korea's MOA Life Plus. It plans to seek FDA clearance for human trials this year, paired with GLP-1 therapies. Veru Veru's oral drug enobosarm targets androgen hormones. In a mid-stage study, patients who took it with Wegovy lost 71 percent less muscle than those on Wegovy plus a placebo. A late-stage study will now assess stair climb power in patients 60 and older. 35 Pharma 35Pharma will soon begin early-stage testing of HS235, which targets activin and GDF ligands involved in muscle, bone, and blood metabolism. Data is expected in the second half of 2025. Arrowhead Pharmaceuticals Arrowhead is developing two RNA-based obesity drugs—ARO-INHBE and ARO-ALK7—that interrupt fat-storage signals. Human trials of ARO-INHBE, both solo and alongside Lilly's tripeptide, are planned for this year. Six Peaks / AstraZeneca In May 2024, AstraZeneca agreed to pay up to $80 million to Swiss biotech SixPeaks Bio for access to an antibody targeting activin cell receptors. The goal was to protect the muscle during weight loss and potentially acquire SixPeaks down the line.
Yahoo
11-02-2025
- Business
- Yahoo
Arrowhead Pharmaceuticals Inc (ARWR) Q1 2025 Earnings Call Highlights: Strategic Collaborations ...
Net Loss: $173.1 million or $1.39 per share for the quarter ended December 31, 2024. Revenue: $2.5 million for the quarter ended December 31, 2024. Total Operating Expenses: $163.9 million for the quarter ended December 31, 2024. Cash and Investments: $552.9 million at December 31, 2024; pro forma cash and investments would be $1.4 billion including Sarepta payments. Cash Used by Operating Activities: $146.3 million for the quarter ended December 31, 2024. Common Shares Outstanding: 125.6 million at December 31, 2024. Warning! GuruFocus has detected 5 Warning Signs with ARWR. Release Date: February 10, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) closed a significant license and collaboration agreement with Sarepta Therapeutics, expected to bring in $1.375 billion in cash payments. The company is now funded into 2028, with potential for multiple commercial launches by Arrowhead and its partners. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) anticipates its first commercial launch of plozasiran, which could drive substantial growth pending FDA approval. The company is focusing on three primary value drivers: plozasiran, obesity, and CNS, which are expected to fuel growth in the near term. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) has a robust potential catalyst calendar for 2025, with multiple key events expected throughout the year. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) reported a net loss of $173.1 million for the quarter ended December 31, 2024, compared to a net loss of $132.9 million in the previous year. Revenue for the quarter was $2.5 million, down from $3.6 million in the same quarter of the previous year. The company experienced increased operating expenses, primarily due to higher candidate costs and salaries as its pipeline of clinical candidates advanced. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) needs additional capital to start a cardiovascular outcomes trial (CVOT) for plozasiran, despite having a significant cash balance. The company faces challenges in expanding the market for its products, as the industry requires education and awareness to address largely untreated diseases. Q: Can you discuss the potential of ARO-INHBE in obesity treatment and its role as a standalone or combination therapy? A: James Hamilton, Chief of Discovery and Translational Medicine, explained that ARO-INHBE is being studied both as a monotherapy and in combination with tirzepatide. The development path will depend on the data outcomes, and there is no specific target to hit at this stage. The obesity market is diverse, and Arrowhead is developing a suite of drug candidates to address various needs. Q: What feedback have you received from doctors regarding APOC3 and current commercial launches? A: Christopher Anzalone, President and CEO, noted that feedback on plozasiran has been positive, with physicians and patient societies expressing enthusiasm due to its differentiating attributes, despite other available options. Q: Will the Phase I/IIa trial for ARO-INHBE and ARO-ALK7 provide weight loss or body composition data? A: James Hamilton confirmed that the trial will assess body composition using full-body MRI and weight loss, alongside safety, plasma PK, and biomarker activity in the blood. Q: Can you provide more details on the SHASTA-5 study and its potential impact on pancreatitis outcomes? A: The SHASTA-5 study is the first of its kind focusing on pancreatitis as the primary endpoint. Enrollment timelines are uncertain, and the study will continue until the required number of events are observed. It is expected to be significant for payers and health technology assessment organizations, particularly outside the US. Q: What are Arrowhead's plans for plozasiran's commercialization in Europe? A: Andy Davis, Senior Vice President, Cardiovascular/Metabolic Franchise Head, stated that Arrowhead plans to commercialize plozasiran in European markets with a commercial partner, with more details to be provided in the future. Q: How does Arrowhead view plozasiran's competitive positioning relative to olozarsen in FCS and severe hypertriglyceridemia? A: Andy Davis highlighted plozasiran's unprecedented triglyceride reduction, ability to achieve guideline-directed risk thresholds, and statistically significant reduction in acute pancreatitis risk as key differentiators. Bruce Given added that the market is more about expansion and education rather than direct competition. Q: What is the strategy for the CVOT study for plozasiran, and what are the gating factors for its initiation? A: Christopher Anzalone stated that the CVOT study is contingent on securing additional capital. The study is scientifically important to assess residual cardiovascular risk related to triglycerides, and Arrowhead is exploring partnerships to fund it. Q: What are the plans for zodasiran in HoFH, and how does it compare to existing treatments? A: Bruce Given explained that zodasiran targets the same patient population as existing treatments but offers quarterly dosing and potentially fewer allergic reactions. The focus is on patients with high LDL cholesterol despite high-dose statins and PCSK9 inhibitors. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
