Claritas Pharmaceuticals Inc V.CLAS.H

RE:NEWS: Several files on SEDAR dated 28 MAY 2021

[whisky11]

Amazigh]Several files on SEDAR dated 28 MAY 2021
https://www.sedar.com/DisplayCompanyDocuments.do?lang=EN&issuerNo=00021766


whisky11: This is"Amazing" news.

from SEDAR:

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R-107 was tested in a classic and well-validated animal model of PAH, induced by administration of monocrotaline (“MCT”) to rats. The data from this study were exceptionally positive. In an acute setting, a single dose of R-107 was able to reverse severe pulmonary arterial hypertension back to a normal level of blood pressure for more than 24 hours, constituting a profound correction that is unprecedented in the scientific literature. In a chronic setting, daily administration of R-107 was able to entirely prevent the increase in pulmonary arterial blood pressure that triples in untreated animals exposed to MCT. Most importantly, a 2-week course of daily R-107 initiated 28 days after the onset of MCT-induced PAH surprisingly showed a 50% reduction in pulmonary blood pressure that persisted after the cessation of the course of R-107 therapy. This durable amelioration of PAH, which constituted a true reversal of disease severity, has not been heretofore witnessed in this gold-standard PAH model system and represents therefore a potential paradigm shift in the management of PAH. Up to now, the objective of clinical PAH therapies is to slow progression of a terminal disease. These new data, evidencing a reversal of disease severity, are qualitatively different and will allow the company to focus on a fundamental correction of underlying disease. By comparison, in this same animal model, the currently approved drugs for PAH have been shown to slow the progression of the disease, but not the ability to completely block its progression.

Claritas expects to complete a Phase 1 clinical study of R-107 in 2021, and to complete a pilot Phase 2a clinical study of R-107 in hospitalized PAH patients in 2022.

R-107 in the injectable formulation will be initially evaluated in a Phase 1 single ascending dose escalation study in healthy volunteers at CMAX in Adelaide, Australia this year. Thereafter, a Phase 2a study will evaluate 12-15 patients with chronic PAH undergoing route cardiac catheterization.

The Phase 2a clinical study of R-107 will be conducted at Royal Adelaide Hospital in Adelaide, Australia in order to establish proof-of-concept that the reduction in blood pressure is restricted to the pulmonary circulation, without a concomitant impact on peripheral hemodynamics. Due to the short period of observation of each study participant (24 hours) and the relatively small number of

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patients under examination, the Company believes that the Phase 2a clinical trial may be readily conducted at a single site and completed within several months.

Demonstration of proof-of-concept could provide the scientific foundation for an immediate sale or strategic out-licensing of R-107 on highly favorable terms. If Claritas is able to demonstrate a selective reduction in blood pressure of a magnitude similar to what was demonstrated in the MCT- induced rodent model of the disease, the Company believes that R-107 will be viewed as a significantly valuable pharmaceutical asset, given that achievement of the Phase 2a clinical trial endpoints should constitute a major inflection point in the value of the technology.