Syngene has commenced a bioequivalence study on an injectable intended for type-2 diabetes and weight regulation, following the approach of a global pharmaceutical firm seeking to partner for outsourced human pharmacological studies of semaglutide. The reference medication, Ozempic, is used for managing type-2 diabetes and obesity.
The objective of the study is to assess the safety of administering semaglutide through injection in healthy individuals, as well as to verify bioequivalence between the reference product (Ozempic) and the client’s test product. This is essential for filing an abbreviated new drug application (ANDA) to secure marketing authorization within the European Union.
In providing insights, a Syngene spokesperson pointed to the project as a testament to the company’s reputation as a reliable partner for BA/BE studies, both in small molecules and biologics. The representative emphasized that around 80% of the company’s business is generated by repeat clients, underscoring the high caliber of services offered.
The human pharmacology division of Syngene is fully equipped with an in-house bioanalytical laboratory, intensive care facilities, among others. The facility boasts a pool of over 23,000 healthy volunteers and maintains a minimal dropout rate of 5%. Having executed 800+ BA/BE studies and phase-1 clinical trials, the scientists at Syngene possess substantial expertise in managing intricate clinical studies, the spokesperson further noted.
Participants in the study received a 1 mg injection of semaglutide in the abdominal area while fasting, using a pre-filled pen. Due to the prolonged half-life of the drug, blood samples were gathered from participants over a 28-day period, including a 48-day washout interval between each dose.
The study faced clinical hurdles such as extended duration which demanded multiple subject visits, potentially impeding recruitment and impacting study results.
Analytical challenges were present in developing LC-MS/MS assays for biologics, characterized as small proteins needing a blend of scientific and operational expertise for complex bioanalytical processes. This capability is usually in-house for major biopharmaceutical companies.
Initially, Syngene adopted a risk management framework, followed by recruiting volunteers for the study. With an ample supply of healthy volunteers, recruitment proceeded smoothly. Prior recruitment, the project team underwent training on administering the 1 mg dose of semaglutide subcutaneously via the pre-filled pen, the spokesperson indicated.
As the study advanced, some participants reported mild to moderate adverse events. Syngene’s investigation team assessed the situation, devising solutions after discussions with the client and internal teams. Subjects received suitable treatments for side effects, alongside personalized dietary recommendations to enhance their nutrition.
Continuous communication with participants was upheld to guarantee health and safety at every phase. Accommodation was provided near Syngene’s clinical unit, ensuring immediate healthcare access as needed, with discharge implemented only post comprehensive health evaluations.
The project team successfully completed the study, supervised closely by the client who expressed satisfaction with both the methodology and outcome. Ultimately, the study confirmed the product met its objectives, marking a significant achievement for both the client and Syngene’s clinical team, expressed the spokesperson.