The path to value creation
Our goals are set, and we are preparing for the next step in taking linaprazan glurate to the market. After evaluating the results of the ongoing clinical testing phase, we will proceed in fine-tuning and adjusting linaprazan glurate to be an effective treatment for unmet medical needs in eGERD and GERD.
Presented below is a brief version of the IP strategy and product development strategy, built on essential milestones for taking the strong lead candidate linaprazan glurate to the market.
Regulatory guidelines are available, and a de-risked development program is ongoing.
1. Continue to seek regulatory advice
European Medicines Agency (EMA) or Medical Products Agency (MPA)
Regulatory advice received on phase II design and target indication, as well as the phase III design
Preparing Clinical Trial Application
IND process ongoing
Regulatory guidelines on treatment of GERD with acid inhibitory drugs are available
Cinclus Pharma expects the same primary endpoints in phase II and phase III.
2. Proven mode of action (Linaprazan)
Safety data on the active metabolite known.3)
Linaprazan, the active metabolite, was safe and well tolerated based on studies in ~2,500 subjects and standard pre-clinical studies needed for regulatory submission for market access (including two-year carcinogen studies in two species).
3) Kahrilas P, et al (2007)
3. Determined intragastric acid control
CUT-OFF 240 nmol/L = pH >4
Clear PK/PD relationship, phase I data
Plasma concentrations of linaprazan glurate´s active metabolite linaprazan determines intragastric acid control (pH >4).
pH level related to plasma concentration of linaprazan
4. Excellent biomarker
Efficacy predictable from phase I
Excellent biomarker in phase I to predict clinical outcome in phase II and III (healing of esophagitis).
Mean percentage of time the intragastric pH>4 determines healing rate