Our path to value creation
Following the successful completion of a first-in-man study of linaprazan glurate, the next planned step is to initiate a phase II study in H1 2021. The primary purpose of this proof-of-concept trial is to gain further understanding of the safety profile and establish the efficacy of linaprazan glurate in healing of grade C and D esophagitis. Following the completion of the phase II study, initiation of a phase III program in the same target population is slated for 2022.
Proven mode of action
Safety data on parent drug known1)
Linaprazan, the active metabolite of linaprazan glurate, 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).
Cut-off 240 nmol/L = pH >4
Clear PK/PD relationship, phase 1 data
Plasma concentrations of linaprazan glurate´s active metabolite linaprazan determines intragastric acid control (pH >4).
pH level related to plasma
concentration of linaprazan
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 rate2)
Note: 1) Kahrilas P, et al (2007). Dent J, et al (2008). 2) Yuan, Thabane & Hunt (2007).
The clinical development program is de-risked by the dose-linear acid control shown in the recently conducted phase I study of linaprazan glurate, as well as by the extensive documentation of linaprazan glurate's active metabolite linaprazan which has been previously studied in some 2,500 individuals.
Cinclus Pharma is working together with regulatory authorities to ensure an optimal regulatory path towards approval of linaprazan glurate.
The regulatory guidelines are clear-cut, and an IND process has already been initiated in the US.
with regulatory authorities
EMA3) or MPA4)
Note: 3) EMA = European Medicines Agency. 4) MPA = Medical Products Agency. 5) IND = Investigational New Drug.
The successful Japanese launch by Takeda of the first P-CAB drug, Takecab, has further substantiated the large unmet medical need and the potential for linaprazan glurate. Compared to Takecab, linaprazan glurate provides superior acid control.
The planned target segments at launch comprises patients with severe esophagitis (grade C and D), as well as patients with incomplete response to PPIs. The estimated total size of this target population in Europe and the US/Canada, based on epidemiological data, is 18.5 million people, indicating a blockbuster potential for linaprazan glurate.
There are attractive opportunities to extend the future use of linaprazan glurate beyond severe esophagitis, particularly into on-demand treatment of GERD, H. pylori eradication, nocturnal GERD symptoms and bleeding ulcers. The linaprazan glurate prodrug molecule has patent protection until 2029 plus potential extension of approximately five years.
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