Societal CDMO wins tech transfer and production contract for HIV drug candidate
pharmafile | August 5, 2022 | News story | Medical Communications |
Societal CDMO, a contract development and manufacturing organisation (CDMO) has been selected to provide CDMO services to support the ongoing clinical development of a novel HIV drug candidate in Europe.
The compound is an oral solid dose anti-viral therapy approved for the prevention and treatment of HIV in certain countries in Europe. Societal has shared its work will be focussed on supporting the expansion of the product’s indications.
Societal CDMO is dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development.
Under the terms of the new agreement, Societal CDMO will execute appropriate technology transfer activities, followed by cGMP manufacture of clinical trial material, to support the initiation and execution of Phase II studies of the drug candidate.
This work will include production, packaging, and labelling of both the active compound, and matching placebo for the study.
There were approximately 1.5 million new HIV infections in 2021, according to a new report by UNAIDS, a joint UN program advocating for global action to address the HIV and AIDS epidemic. Its data shows HIV infections have increased since 2015 in 38 countries globally, and that every day, 4,000 people become infected with HIV, including 1,100 young people aged 15 to 24 years old.
“We are proud to be trusted by our partner to execute the tech transfer, manufacturing and packaging services that will be necessary for the initiation of its planned Phase 2 study in Europe,” said David Enloe, CEO of Societal CDMO. “We continue to be pleased with our progress in leveraging our end-to-end CDMO service offerings to grow our business and expand our client base.”