Camurus reports positive topline results for CAM2056, semaglutide monthly depot

• CAM2056 showed weight and A1c reductions comparable to or exceeding those seen for weekly semaglutide (Wegovy®)
• Results include a 9.3% weight reduction with CAM2056 vs. 5.2% with weekly semaglutide at Day 85
• Safety and tolerability were consistent with weekly semaglutide
• CAM2056 has potential for monthly dosing with rapid initiation

LUND, Sweden, Nov. 10, 2025 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced positive topline results from a randomized, active-controlled Phase 1b study evaluating CAM2056, the company's monthly FluidCrystal® semaglutide formulation, in comparison to weekly semaglutide (Wegovy®)¹ in 80 individuals with overweight or obesity. The study showed that CAM2056, given as two biweekly initiation doses followed by two monthly doses, was well tolerated, up to the highest initiation dose, and significantly reduced body weight, hemoglobin A1c (A1c), and fasting glucose in a dose-dependent manner. The reductions were comparable to or exceeded those with weekly semaglutide dosed according to prescribing information¹.

"We are very pleased with the Phase 1b data showing that CAM2056 is well tolerated and achieves dose-dependent reductions in body weight and A1c, matching or exceeding those observed with weekly semaglutide," says Fredrik Tiberg, President & CEO, CSO of Camurus. "The study data suggest that CAM2056 allows rapid dose titration without compromising tolerability, whilst also allowing convenient monthly dosing. Further evaluation of CAM2056 is planned in an upcoming Phase 2b study."

CAM2056 is a monthly subcutaneous semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist formulated with Camurus' proprietary FluidCrystal® technology.

Topline results from the Phase 1b study include:

• CAM2056 achieved a similar maximum plasma concentration (Cmax) at a four times higher monthly dose compared to weekly semaglutide. Additionally, CAM2056 showed longer time to Cmax and an extended-release profile suitable for monthly dosing.
• CAM2056 provided dose-dependent reductions in body weight, A1c and fasting glucose, comparable to or exceeding those with weekly semaglutide to end of treatment, Day 85
• The mean weight change from baseline to Day 85 for CAM2056 10 mg was -9.3% compared to -5.2% for weekly semaglutide dosed as per prescribing information. The treatment difference was -4.1% (-7.1%, -1.1%), p=0.008. CAM2056 reached similar weight reduction after 3 months as weekly semaglutide after 5 months.
• The mean A1c change from baseline to Day 85 was -0.44%, after the last 10 mg dose. The treatment difference between CAM2056 and weekly semaglutide was -0.32% (-0.50%, -0.14%), p<0.001.
• The safety and tolerability profile of CAM2056 was favorable, despite higher initial doses and more rapid dose escalation compared to weekly semaglutide. Only the last cohort with the highest initiation dose showed a tendency for more frequent and severe events. For all other cohorts, the safety profile was consistent with weekly semaglutide dosed as per prescribing information. The most common adverse events were mild to moderate and transient gastrointestinal adverse (GI). Only a limited number of injection site reactions were reported in the study, all of which were mild and transient. A small number of participants stopped treatment early in these cohorts: one to two per arm for CAM2056, and two for weekly semaglutide (n=16).

FluidCrystal® is a registered trademark of Camurus. Wegovy® is a registered trademark of Novo Nordisk.

For more information
Fredrik Tiberg, President & CEO, CSO
Tel. +46 (0)46 286 46 92
[email protected]

Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
[email protected]

About CAM2056 and semaglutide solution for injection
CAM2056 is a long-acting, subcutaneous semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. The weekly semaglutide solution for injection is marketed for weight management (Wegovy®)¹ and to improve glycemic control in type 2 diabetes mellitus patients (Ozempic®). CAM2056 is formulated with Camurus' proprietary FluidCrystal® technology, which is commercially validated and used in marketed pharmaceutical products^3,4.

About the Phase 1b study
The Phase 1b study was a multi-arm, repeated-dose, randomized, active-controlled study, with a separate dose-escalation part, designed to assess the pharmacokinetics, pharmacodynamics, and safety and tolerability of CAM2056 in 80 adult participants (16 in each cohort) with overweight or obesity (BMI=27 to 39.9) who were otherwise healthy. In the first part, participants were randomized 1:1:1 to weekly semaglutide and two formulations of CAM2056. The second part of the study investigated escalating starting and monthly doses with CAM2056 to explore dose response, safety and tolerability. Treatment with CAM2056 was in all cohorts started with two biweekly initiation doses followed by two monthly doses, while weekly semaglutide was administered for five months according to the prescribing information (Wegovy®)¹. The highest CAM2056 initiation dose was 5 mg and the highest monthly dose was 15 mg. Camurus plans to start a Phase 2b trial of CAM2056 in 2026, featuring longer treatment duration and elevated doses.

About obesity and type-2 diabetes
Obesity is a significant global health issue associated with various comorbidities, including type 2 diabetes, cardiovascular diseases, steatohepatitis, and chronic kidney disease. It is estimated that over 1 billion individuals globally were affected by obesity in 2022, representing approximately one in eight people worldwide. This figure comprises nearly 880 million adults and 159 million children and adolescents aged 5 to 19 years. Since 1990, adult obesity has more than doubled, and it has quadrupled among children and adolescents. This increase has notable implications for societies and healthcare systems worldwide.⁴ 

Type 2 diabetes is a long-term condition in which the body does not produce sufficient insulin or becomes resistant to insulin, resulting in elevated blood glucose levels. Its development is associated with factors such as excess body weight, limited physical activity, dietary choices, and genetic predisposition. A1c is regarded as a standard method for assessing long-term glycemic control.^5,6

About Camurus

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund, Sweden. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn .

References

1. Wegovy®  SmPC  
2. Buvidal®  SmPC
3. Oczyesa®  SmPC
4. World Health Organization (WHO), Obesity and overweight. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight .
5. Center for Disease Control (CDC). Diabetes Risk Factors. https://www.cdc.gov/diabetes/risk-factors/index.html .
6. CDC. A1C Test for Diabetes and Prediabetes. https://www.cdc.gov/diabetes/diabetes-testing/prediabetes-a1c-test.html .

This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 8:00 am CET on 10 November 2025.

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https://news.cision.com/camurus-ab/r/camurus-reports-positive-topline-results-for-cam2056--semaglutide-monthly-depot,c4264164

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