Catalent and pharmaceutical company Grünenthal have announced their successful formulation design and clinical-phase manufacturing collaboration for an orally dosed small molecule in Grünenthal's pipeline.
Positive preclinical results from the molecule have allowed Grünenthal to progress its development program to first-in-human studies. In this phase, Catalent supported Grünenthal with the development of a bioavailability enhanced formulation, which, moving forward, enables expedited clinical development timelines.
The two companies have been working together on this program since 2021. Catalent has assisted Grünenthal in reformulating the molecule using a lipid-based drug delivery system formulated in softgel technology to improve its bioavailability.
The Catalent Xpress Pharmaceutics platform provides the flexibility to efficiently manage our candidates through early clinical development studies
Scientific experts at Catalent's facilities in Beinheim, France, and Nottingham, UK, carried out this development work using its OptiForm Solution Suite platform, which allowed the rapid characterisation and screening of dose forms and formulation technologies to optimise dose design.
Phase 1 studies of the molecule will be supported by scientists from Beinheim using the Catalent Xpress Pharmaceutics platform, which provides rapid development of clinical formulations and on-demand manufacturing of dose forms at the clinical research organisation undertaking the trials. Trials will be run for both single ascending dose (SAD) and multiple ascending dose (MAD) studies based on the real-time results of the adaptive study protocol.
"The OptiForm Solution Suite provides an efficient approach to expedite innovative candidates into first-in-human studies. It does this through assessing a broad range of technical solutions to identify the most suitable formulation for the specific candidate," said Stephan Bulat, Head of Chemistry, Manufacturing and Controls at Grünenthal. "The Catalent Xpress Pharmaceutics platform provides the flexibility to efficiently manage our candidates through early clinical development studies, supporting our ambition to achieve best-in-class development timelines."
The OptiForm Solution Suite provides an efficient approach to expedite innovative candidates into first-in-human studies
"With innovators demanding shortened drug development timeframes, Catalent offers a number of integrated solutions to ensure programs can be accelerated to, and through, clinical phases as quickly and safely as possible, while providing design and delivery technology support to give molecules the greatest chance of success," said Ricky Hopson, President, Division Head for Clinical Development and Supply, Catalent. "Working with Grünenthal, we have been able to leverage multiple services that have not only reduced Phase 1 development timelines substantially, but have done so using a formulation and delivery technology that is scalable for future clinical and commercial needs as the program progresses."
Grünenthal is dedicated to creating innovative non-opioid pain treatments that address unmet medical needs. For R&D, Grünenthal executes a distinctive therapeutic area strategy and focuses on four key pain indications: peripheral neuropathic pain, chronic post-surgical pain, chronic low back pain, and osteoarthritis. Grünenthal seeks collaborations in these areas to develop life-changing treatments for patients, independent of the modality and their stage of development. To date, the company has launched six treatment options for patients suffering from pain.
