Semaglutide(Biocon)

London: The rise of GLP-1 receptor agonists (GLP-1RAs) has dramatically reshaped the treatment landscape for diabetes and obesity—and nowthese therapies are moving to disrupt a broader range of other chronic conditions. According to a new analysis by data and analytics platform GlobalDatathe development pipeline for GLP-1RAs is expanding rapidlywith ongoing trials targeting not only metabolic disorders but also neurodegenerative conditions such as Alzheimer’s disease. The chronic nature of these conditions and the shared biological mechanisms involved are prompting researchers to explore how the insulin-sensitizing and anti-inflammatory properties of GLP-1RAs could be leveraged across therapeutic areas. Key opinion leaders (KOLs) interviewed by GlobalData noted“If pivotal trials prove effective for Alzheimer’s and other neurological disorderstreatment guidelines as we know them could change completely.” “The GLP-1RA space is bound to expand,” said Costanza AlciatiPharma AnalystGlobalData said“Their ability to combat insulin resistance appears central to not only type 2 diabetes and obesitybut also to neuroinflammation seen in Alzheimer’s disease.” HoweverAlciati cautions that despite the promising safety profile of these drugs so far“ensuring long-term safety remains one of the biggest unmet needs in this therapeutic class.” GLP-1RAs work by mimicking a gut hormone—glucagon-like peptide-1—that binds to GLP-1 receptors located throughout the body. These receptors help regulate blood sugarinsulin secretionappetiteand digestion. The therapeutic journey began with Danish pharmaceutical major Novo Nordiskwhich introduced liraglutide (Victoza) for type 2 diabetes. The company followed with semaglutidemarketed as Ozempic for diabetes and Wegovy for obesity. These brands have become category-defining benchmarks globally. Following Novo’s leadEli Lilly launched its own class-defining GLP-1RA therapies— Mounjaro and Zepboundbased on the active molecule tirzepatide. In 2024Mounjaro generated global net sales exceeding $11 billion (₹94,000 crore)making it the world’s highest-valued drug brand. Lilly is also actively investigating tirzepatide across multiple new indications including obstructive sleep apnea (OSA)heart failureand chronic kidney disease . Indian pharmaceutical firms are not far behind. Earlier this yearBengaluru-based Biocon launched a biosimilar version of GLP-1RA for diabetes in the UK. Meanwhilecompanies like GlenmarkDr. Reddy’sand Wockhardt are developing generic versions of semaglutidewith launches anticipated once patents expire in India next year. NotablyIndia’s largest pharma companySun Pharmais also working on an original moleculeUtreglutidewith a commercial launch expected in the next five years. As GLP-1 therapies gain popularity for their non-invasive delivery and broad systemic benefitsglobal and Indian pharma companies alike are racing not only to stake a claim in the booming metabolic disorders market—but also to explore potential repositioning across multiple chronic conditions. By Online Bureau ,

iStock z_wei Biopharma doubles down on immunology and inflammation as companies target new pathways and seek to improve on current options in inflammatory bowel diseaseatopic dermatitismyasthenia gravis and more. One of biopharma’s hottest therapeutic areasimmunology and inflammation has seen an uptick in M&A activity in recent yearswith big names like Sanofi and Gilead dropping billions of dollars to expand their I&I pipelines. At the same timethe space is seeing an influx of new companiesincluding Bambusa Therapeutics which launched Friday with $90 million in series A funds. Momentum in this space was sparked at the turn of the century by the arrival of therapeutic antibodies. After winning FDA approval in 2002Abbvie’s Humira—the first tumor necrosis factor (TNF) inhibitor—became one of the best-selling drugs of all timegenerating over $200 billion in lifetime sales to patients with rheumatoid arthritispsoriasisulcerative colitisCrohn’s disease and more. Over 20 years laterwith Humira and other key medicines having lost their exclusivity and research providing a better understanding of the biology underlying the fieldit’s time for the next wave of I&I. Indeednovel targets and modalities are attracting an influx of investment into the I&I spacesaid Thomas Smitha senior research analyst covering immunology at Leerink Partners. “We’re seeing antibodies that are going after targets that have not been targeted beforesmall molecules that were previously thought to be undruggable,” he told BioSpace . “We’re seeing the emergence of cell therapies.” And there’s room for them all. The second largest therapeutic area by value in 2023the immunology market is projected to be worth more than $257 billion by 2032. “[I&I] has large end markets of highly prevalent diseases thatdespite having multiple treatment optionsstill have persistenthigh medical need,” Smith said. M&A Expected to Continue in 2025 The I&I space has made headlines recently for a spate of high-pro In April 2024Vertex struck the biggest deal in biopharma last year with its $ 4.9 billion buy of Alpine Immune Sciences. Then in JuneEli Lilly dropped $3.2 billion to acquire Morphic Holding. These deals followed Merck’s eyepopping $10.8 billion pick-up of Prometheus Biosciences a year earlier. While many big pharma companies already have their own immunology platforms“innovation does not happen in isolation,” Shaju Backerglobal head of immunology at Sanofitold BioSpace in an email. This is why his company also complements its in-house R&D with a myriad of strategic partnerships and acquisitions. In 2021Sanofi acquired Kymab for $1.4 billion to add an anti-OX40 ligand to its pipelinehoping to address the underlying disease pathologies of inflammatory diseases like atopic dermatitis without depleting T cells. More recentlyGilead struck a deal last month with LEO Pharma worth up to $1.7 billion for its preclinical STAT6 program. Smith expects more of the same in the near future. “We have a lot of reason for thinking this is going to continue to be the case in 2025,” he said. Pursuit of Novel Targets TNF blockers like Humira cast a wide netpulling in some ten indications. Yet patients and practitioners have seen the effects of Humira and other anti-TNF therapies wear off relatively quickly because ancillary pathways take overaccording to Backermaking it necessary to target other pathways for disease management andhopefullyremission. One of thesethe TL1A pathwayplays a key role in driving inflammation and fibrosis in various autoimmune diseasesmaking its inhibition a promising strategy for multiple indicationsincluding inflammatory bowel disease (IBD). Merck’s Prometheus buy brought in a potentially best-in-class TL1A inhibitor in late-stage studies for ulcerative colitis and Crohn’s disease. And Sanofi is co-developing a TL1A-targeting antibodyduvakitugwith Teva Pharmaceuticals. Another target generating a lot of interest is the signal transducer and activator of transcription 6 (STAT6) transcription factorwhich is a key regulator of Th2-driven immune response. Indication potential is wide-ranging for STAT6-targeted oral drugswhich could offer an alternative to existing injectable biologics. Gilead’s recent deal with LEO Pharma is one example. While the specific indication has not yet been announcedFlavius Martinexecutive vice president of research at Gileadtold BioSpace in an email that the program is “advancing rapidly” toward clinical testing. ElsewhereSanofi extended its collaboration with Nurix Therapeutics last year to include a targeted protein degrader of STAT6. These are but a few of the many targets now being explored in the I&I space. Others run the gamut from Sanofi’s T cell receptor–targeting amlitelimab for atopic dermatitiswith a 52-week data readout expected in Marchto the microRNA-targeting obefazimod from Paris-based biotech Abivaxwhich is awaiting a Q3 2025 Phase III readout in ulcerative colitis. Finallythe “unbridled success” of cell therapies in hematological malignancies is now driving efforts to bring cell therapy to the I&I spaceparticularly for autoimmune disease Smith said. Companies like Kyverna are developing CAR T cell therapies to deliver complete B cell depletion that could help reset a patient’s immune system to eliminate the need for chronic treatment. Kyverna is targeting a 2026 filing for its lead therapy KYV-101 in stiff person syndromewith myasthenia gravis and lupus nephritis to follow. MeanwhileArcellx is taking its cell therapy pipeline from multiple myeloma into autoimmune disease. Last fallthe FDA cleared the company’s Investigational New Drug (IND) application to begin a Phase I trial of its CAR T anito-cell in generalized myasthenia gravis. If successfulSmith said the biggest challenges to cell therapies for autoimmune indications would be logisticsscalabilityreimbursement and identifying the right patients for treatment. The beauty of the I&I space is that one molecule can have many different applicationsJorge Santos da SilvaCEO of Moonlake Therapeuticswhich is developing treatments for inflammatory indications including hidradenitis suppurativatold BioSpace . “In I&Iyou can have these molecules that just walk across a whole lot of therapeutic areas,” a feature he said makes it ripe for investment by biopharma. Smith agreed. “The end markets for I&I relative to targeted oncology are much broader,” he told BioSpace . “There’s a lot of white space.” 5 I&I Diseases Poised for Disruption in 2025 Thomas Smitha senior research analyst covering immunology at Leerink Partnershighlighted five indications within the I&I space that he believes could see substantive movement this year. Editor’s note: Lists of approved products and products in development are not comprehensive. Metabolic Dysfunction-Associated Steatohepatitis (MASH) The most severe form of nonalcoholic fatty liver diseaseMASH affects 5% to 7% of the global population. Approved Products : Madrigal’s Rezdiffra In Development : Akero Therapeutics’ efruxifermin (Phase III) Boehringer Ingelheim’s survodutide (Phase III) Novo Nordisk’s semaglutide (Phase III) Eli Lilly’s tirzepatide (Phase II) Inflammatory Bowel Disease Inflammatory bowel disease (IBD)—including ulcerative colitis (UC) and Crohn’s disease (CD)—affects between 2.4 and 3.1 million people in the U.S. Approved Products : Eli Lilly’s Omvoh Johnson & Johnson’s Remicade AbbVie’s Humira In Development : Abivax’s obefazimod for UC (Phase III) Sanofi and Teva’s duvakitug for UC (Phase II) Equillium and Biocon’s Itolizumab for UC (Phase II) Myasthenia Gravis A chronic autoimmune disorder causing weakness in the voluntary musclesmyasthenia gravis afflicts up to 60,000 people in the U.S. Approved Products : Argenx’s Vyvgart AstraZeneca’s Ultomiris UCB’s Rystiggo In Development : Johnson & Johnson’s nipocalimab (under review) Cabaletta Bio and Kyverna Therapeutics’ CABA-201 (Phase I/II) COUR Pharmaceuticals’ CNP-106 (Phase II) Atopic Dermatitis Atopic dermatitis—a chronic skin condition that causes the skin to become reditchy and inflamed—affects more than 7% of people in the U.S. Approved Products: Sanofi and Regeneron’s Dupixent Eli Lilly’s Ebglyss Galderma’s Nemluvio In Development : Sanofi’s amlitelimab (Phase III) Kymera Therapeutics and Sanofi’s IRAK4 (Phase II) Apogee Therapeutics’ APG777 (Phase II) Hidradenitis Suppurativa Another chronicinflammatory skin conditionhidradenitis suppurativa afflicts 1% to 4% of the global population. Approved Products : AbbVie’s Humira Novartis’ Cosentyx UCB’s Bimzelx In Development : Moonlake Therapeutics’ sonelokimab (Phase III) Incyte’s povorcitinib (Phase III)