• 22 Nov 2024
• Admin
• News Article

Syngene Embarks on Evaluating the Bioequivalence of an Injectable for Type-2 Diabetes and Weight Management

Overview

Syngene has embarked on evaluating bioequivalence of an injectable for type-2 diabetes and weight management. This was after a global pharma company was scouting for a partner to outsource its human pharmacological studies for semaglutide. The reference drug, Ozempic, was an anti-diabetes and anti-obesity medication for treating type-2 diabetes and for long-term weight management.

The Safety Study 

• The study was to evaluate the safety aspects of semaglutide administered as an injectable in healthy adults. 
• It was also meant to establish bioequivalence between the client’s test product and the reference product (Ozempic) for filing an abbreviated new drug application (ANDA) for marketing authorization in the European Union. 

Statement from Syngene 

• Sharing details, a Syngene spokesperson said that the project is a prime example of why we are a trusted partner for BA/BE studies for small molecules and biologics. 
• Testament to the high quality of work we deliver is the fact that nearly 80% of our business is from existing clients. 

The Human Pharmacology Lab

• Our human pharmacology unit is equipped with an in-house bioanalytical lab, and an intensive care unit, among other facilities. 
• We have a pool of over 23,000 healthy volunteers and a low drop-out rate of 5%. 
• Further, with experience in 800 BA/BE studies and phase-1 clinical trials, our scientists have significant experience in handling complex clinical studies, he added. 

Semaglutide Study

• Semaglutide (1 mg) was injected into healthy study subjects in the abdominal region via a pre-filled pen under fasting conditions. 
• Since the drug has a long half-life, the study involved the collection of blood samples from the subjects over a 28-day duration, including a washout period of 48 days between each dose.

Clinical Challenges

• These included long duration of the study which required multiple visits by subjects, which could lead to recruitment delays and missed visits, affecting the study outcome.
• Among the analytical challenges were developing LC-MS/MS assays for biologics which are small proteins requiring a range of scientific and operational experts to execute complex bioanalytical methods. 
• Generally, only large biopharma companies possess this capability in-house.

The Process Behind Study

• As a first step, Syngene implemented a risk management strategy. 
• The next step was recruiting volunteers for the project. 
• Since Syngene has a large pool of healthy volunteers, recruitment of subjects did not pose any hurdles. 
• Prior to recruitment, we trained our project staff in administration procedure of subcutaneous injection of 1 mg semaglutide via a pre-filled pen, stated the spokesperson.
• As the study progressed, more subjects started complaining about adverse events of mild to moderate severity. 
• The Syngene investigator team analyzed the situation and devised solutions in consultation with the client and internal teams. 
• Subjects were provided with appropriate treatments based on the nature and severity of the side effects. 
• Further, every effort was made to improve their nutrition levels by suggesting alternatives based on individual food preferences.

Communication During the Study

• Throughout the study, regular communication was maintained with the subjects to ensure their health and safety at every stage. 
• They were provided accommodation near Syngene’s clinical unit to ensure prompt access to healthcare at all times. 
• Due care was also taken to discharge them only after a complete health assessment. 

The project staff ensured the successful completion of the project. The client, keenly supervising the project, was satisfied with our process and the outcome. Overall, the product was declared to have met the study objective which is a significant milestone for both the client and Syngene’s clinical development team, said the spokesperson.