Path to value creation

Our path to value creation

pipeline_cinclus_pharma

Clinical strategy


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
(linaprazan)


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

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 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.

Regulatory strategy


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.

Interactions
with regulatory authorities

EMA3) or MPA4)

  • Request regulatory advise on phase II design and target indication as well as the phase III design

  • Prepare Clinical Trial Application


FDA

  • IND5) process ongoing


Regulatory

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

Note: 3) EMA = European Medicines Agency. 4) MPA = Medical Products Agency. 5) IND = Investigational New Drug.

Commercial strategy


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.

 

A first licensing agreement is already in place with Jiangsu Sinorda Biomedicine Ltd, covering China and certain other territories in South East Asia.

 

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.