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Development strategy

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

 FDA

  • IND process ongoing

Regulatory

  • Regulatory guidelines on treatment of GERD with acid inhibitory drugs are available

 Other

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