Crinetics Pharmaceuticals, a pharmaceutical company that develops therapies for rare endocrine diseases, and Quotient Sciences, a drug development and manufacturing accelerator, have announced a partnership to support Crinetics’ CRN04894 pediatric program. The partnership will utilize Quotient Sciences’ unique Translational Pharmaceutics® platform to provide integrated formulation development, clinical manufacturing, and taste assessment studies to accelerate Crinetics’ development timeline.
Crinetics is currently developing CRN04894 as an investigational, oral, non-peptide product candidate designed to antagonize the adrenocorticotropic hormone (ACTH) receptor, intended for the treatment of diseases caused by excess ACTH, including Cushing’s disease and congenital adrenal hyperplasia (CAH). The pediatric formulation is an oral solution in development for children under two years of age that requires flavoring and sweetening to improve palatability.
Quotient Sciences has over 30 years of experience in pediatric formulation development and taste assessment studies. To support Crinetics’ CRN04894 pediatric program, Quotient Sciences will carry out an integrated, real-time adaptive GMP clinical manufacturing campaign alongside a Phase I clinical study in healthy volunteer subjects to assess the taste and palatability of several oral solution formulations. The development program will evaluate different flavoring agents and sweetener levels in order to identify the optimal formulation.
“There is an art to the development of taste-masked oral products for pediatric indications,” said R. Scott Struthers, PhD, Founder and CEO of Crinetics Pharmaceuticals. “Quotient Sciences’ expertise in improving the taste, smell, and texture of oral formulations makes them the ideal partner for Crinetics’ pediatric clinical programs.”
Mark Egerton, PhD, CEO of Quotient Sciences, added: “We are delighted to partner with Crinetics to support the development and clinical testing for CRN04894. With the industry focused on developing acceptable and palatable pediatric formulations to address patient need and regulatory requirements, we are fortunate that our integrated Translational Pharmaceutics platform offers customers the opportunity to accelerate their development timelines, so that patients can access much-needed medicines faster.”
