Societal CDMO, a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, has been awarded CDMO service contracts from three new customers. The agreements span a range of the company’s offerings including clinical trial services, analytical method and formulation development, and cGMP manufacturing, among others.

“Societal CDMO’s business development team, in conjunction with our technical subject matter experts, has been extremely active in 2022, helping to create significant momentum for our focused efforts to expand our client base and grow our business. The clearest example of this success to date is the recent flurry of new customers wins that we are announcing today,” said David Enloe, CEO of Societal CDMO. “These new agreements spotlight the full range of services that Societal CDMO provides its customers, starting with efforts in the areas as analytical method and process development, as well as formulation design, and advancing into cGMP manufacturing, packaging, labeling and distribution. Importantly, two of these new agreements involve our clinical trial services business, which we view as a key driver of growth for the company. I would like to acknowledge the hard work of our entire team and the excellent results they continue to produce.”

Under terms of the first new contract, Societal will execute a range of clinical trial services to support the initiation of a U.S.-based Phase 2 clinical study of a novel melatonergic antidepressant already approved for use in Europe and Australia. Societal will be responsible for sourcing and preparing the study drug and matching placebo for use in the trial. Additional activities will include packaging and labeling of study drug and matching placebo, as well as storing the prepared materials and distributing them to clinical trial sites within the U.S. These activities will be conducted in collaboration at Societal’s CDMO facilities in Georgia and California.

The second agreement calls for Societal to conduct analytic method activities and development of a liquid oral formulation of an investigational treatment for pediatric patients with dietary restrictions suffering from neurological and neuropsychiatric diseases. Societal will also be responsible for the production and packaging of an initial engineering batch of the liquid oral formulation.

The scope of work under the third new contract includes clinical trial services to support Phase 2 clinical studies of a novel antisense oligonucleotide being developed for the treatment of various cancers. Activities will include labeling and storage of vials of the investigational compound, as well as vial distribution to clinical trial sites.