Cagrilintide

Two weeks after Boehringer Ingelheim pulled the plug on a partnered obesity programme, Gubra is reporting "positive" Phase I data for its long-acting amylin analogue GUBamy (GUB014295), indicating that the Danish biotech's independent assets may offer promising alternatives.In the single ascending dose study, subjects receiving the highest doses (3.5-6.0 mg) achieved approximately 3% weight reduction over six weeks, while the placebo group gained about 1%. The study was conducted in healthy lean and overweight male subjects with a mean body mass index (BMI) of about 26.7 who were randomised into six cohorts treated with either GUBamy or placebo."We are very pleased to see that our data confirms the potential of GUBamy as an anti-obesity treatment," said CEO Henrik Blou. "GUBamy was well tolerated, and the very long half-life supports a weekly dosing regimen."Gubra said the treatment's pharmacokinetic profile revealed a half-life of 270 hours, or 11 days, supporting weekly subcutaneous administration. Adverse events aligned with expectations for the drug class, primarily presenting as gastrointestinal effects including frequent nausea and reduced appetite, with occasional vomiting.Investors are paying close attention to trial outcomes of amylin-based drugs, which could soon represent a new category in weight-loss therapies. Before the end of the year, Novo Nordisk plans to release data from a large study of CagriSema, a combination of the dual amylin and calcitonin receptor agonist cagrilintide, plus GLP-1 agonist semaglutide, the active ingredient in its popular obesity drug Wegovy. The drugmaker recently reiterated its expectation that the new injection will deliver 25% weight loss.Meanwhile, Zealand Pharma has its own amylin compound, petrelintide, and is actively seeking partners to advance the treatment to the next development phases.

Novo Nordisk's flagship obesity treatment Wegovy returned to forecast-topping growth in the company's latest financial results, sending shares up more than 8% on Wednesday. Sales of the GLP-1 product surged 79% in the third quarter to DKK 17.3 billion ($2.5 billion), well above consensus expectations of DKK 15.9 billion.While sales of Wegovy had grown 55% in the previous quarter to DKK 11.7 billion, they came in below consensus estimates of DKK 13.5 billion — a "blip" that Novo attributed to an adjustment of rebates related to estimates made on the prior year's revenue.And ahead of Novo's latest financial print, fears of a repeat in the third quarter had been stoked by Eli Lilly's disappointing sales figures for its competing GLP-1/GIP co-agonist products Mounjaro and Zepbound. Revenue for the two came in below analyst predictions, which Lilly blamed on inventory decreases in the US wholesaler channel. On Wednesday, Novo CEO Lars Fruergaard Jørgensen said that the pharma continues to see "very significant demand" for Wegovy in the US and is working hard to increase manufacturing capacity. However, the company warned that despite earmarking billions of dollars to invest in production, it still faces "capacity limitations" at some sites, along with "periodic supply constraints and related drug-shortage notifications."Weak diabetes sales"Wegovy continues to gain momentum and clearly exceeds expectations in the quarter," compensating for weaker diabetes sales, remarked Sydbank analyst Søren Løntoft Hansen. "This is good enough to provide some relief," added Emily Field of Barclays, explaining that Wegovy's beat came despite slightly worse pricing in the US than anticipated.Novo's overall sales and profit both increased 21% in the third quarter to DKK 71.3 billion and DKK 27.3 billion, respectively. However, the revenue figure came in below analyst projections of DKK 72.3 billion, partly due to lacklustre growth in its diabetes segment, including for Ozempic.In the quarter, Ozempic — which contains the same active ingredient as Wegovy — generated sales of DKK 29.8 billion, up 26% year-over-year at constant currencies, but below forecasts of DKK 30.5 billion.Guidance narrowedFor the full year, Novo said it now expects sales growth of between 23% and 27% on a constant exchange rate basis, narrowed from a prior range of 22% to 28%. Meanwhile, operating profit growth was similarly revised, and is now seen between 21% and 27%, from previous guidance of 20% to 28%.Investors had feared the drugmaker would cut its outlook, noted Terence McManus of Bellevue Asset Management. "However, we don't see these results as an all-clear signal on the stock," he added, with all eyes now set to turn to pending late-stage data for its next obesity hopeful dubbed CagriSema.The therapy, which combines semaglutide — the active ingredient in Ozempic and Wegovy — with the amylin analogue cagrilintide, is expected to lead to weight loss of over 15% when results are unveiled later this year. Martin Holst Lange, Novo's development head, reaffirmed that CagriSema has potential for up to 25% weight loss, with "no change in our confidence level."Other pipeline updatesNovo also disclosed alongside its financial print that the Phase IIIb STRIDE study of Ozempic as an adjunct to standard of care in people with type 2 diabetes and peripheral arterial disease with intermittent claudication met its primary endpoint. The drug demonstrated a clinically relevant and statistically significant improvement in maximum walking distance of 13% compared to placebo. US and EU marketing applications in this indication are targeted for the first half of 2025.Additionally, the company plans regulatory filings next year for its factor VIIIa mimetic bispecific antibody Mim8 in haemophilia A. Following up on the positive Phase IIIa FRONTIER 2 trial, Novo said Wednesday that the Phase IIIb FRONTIER 5 study has now been completed. The trial assessed switching from prophylaxis with Roche's once-weekly therapy Hemlibra (emicizumab) to Mim8 — something Novo reported was well tolerated.Elsewhere, Novo said it has now decided to bin development of the non-steroidal mineralocorticoid receptor antagonist ocedurenone across all indications. The future of the asset — gained from KBP Biosciences for up to $1.3 billion — was under review following the failure in June of the Phase III CLARION-CKD study in patients with uncontrolled hypertension and advanced chronic kidney disease.($1 = DKK 6.92889)