Integrated Synthesis-to-Clinic® Program Will Support HTD1801’s Clinical Development and Regulatory Submission Package
ROCKVILLE, USA; SHENZHEN, CHINA; and NOTTINGHAM, UK: December 15, 2022 – HighTide Therapeutics, Inc. (“HighTide”), a globally integrated clinical-stage biopharmaceutical company focusing on novel multifunctional therapeutics for metabolic and digestive diseases, and Quotient Sciences, a drug development and manufacturing accelerator, have signed an agreement to support HighTide’s HTD1801 program.
The agreement will see Quotient Sciences perform a 14C human absorption, distribution, metabolism, and excretion (ADME) study for HighTide’s lead drug candidate, HTD1801, to generate data to support HTD1801’s clinical development.
HTD1801 is a first-in-class new molecular entity. HighTide’s continued clinical progress with HTD1801 includes an ongoing Phase 2 study for the treatment of type 2 diabetes (T2DM), the initiation of a global Phase 2b study for the treatment of nonalcoholic steatohepatitis (NASH), and the successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for primary sclerosing cholangitis (PSC).
The U.S. FDA has granted HTD1801 Fast Track designation in both NASH and PSC.
Quotient Sciences will be providing a fully integrated Synthesis-to-Clinic® program, from radiosynthesis of the 14C-labeled drug substance to the design and conduct of the human ADME study and delivery of the final clinical study report. The company is currently commencing radiochemistry activities and finalizing the clinical study design.
Mark Egerton, PhD, CEO of Quotient Sciences, said: “We are excited to share our expertise in 14C-enabled drug development with HighTide to support their HTD1801 program, which has the potential to help many patients suffering from T2DM, NASH, and PSC worldwide. Our unique Synthesis-to-Clinic offering streamlines the entire human ADME process by integrating radiolabeled formulation development, real-time drug product manufacturing, and clinical testing in a single program of work led by a single project manager, reducing timelines and getting new medicines to patients faster.”
Liping Liu, PhD, Founder and CEO of HighTide, added: “We are very pleased to enter this collaboration with Quotient Sciences. Both parties have extensive expertise and experience in their respective fields. The study will help us better understand the ADME properties of HTD1801 to continue to advance our global clinical development programs. We expect the alliance to greatly facilitate our clinical progress by completing the ADME program in a more streamlined, time- and cost-effective manner.”
About Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
About HighTide Therapeutics
HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of innovative multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program.
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