Claritas Announces Agreement with CMAX Clinical Research for Phase 1 Clinical Study of R-107

On Apr 22, 2021

Claritas Pharmaceuticals, Inc. announced that it has entered into an agreement with CMAX Clinical Research Pty Ltd (“CMAX”) to conduct a randomized, placebo-controlled, single-blind, single ascending dose Phase 1 clinical study to evaluate the pharmacokinetics and safety profile of the Company’s novel, liquid, nitric oxide-releasing drug, R-107.

R-107 is a Nitric Oxide-Releasing Compound

R-107 is a liquid, nitric oxide-releasing compound with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea.

Claritas initially licensed R-107 from Salzman Group for the treatment of COVID-19 and other viral infections. Claritas announced on April 14, 2021 that, subject to TSXV approval, it will enter into a separate License Agreement under which Salzman Group will also grant to Claritas exclusive, worldwide rights to develop R-107 for the treatment of PAH.

R-107 can be administered by injection, in contrast to nitric oxide gas therapy which requires a special type of delivery device and complex administration by trained respiratory therapists. When administered by intramuscular (“IM”) injection, R-107 steadily and slowly releases nitric oxide. This depot-like action of R-107 results in a sustained delivery of nitric oxide to tissues throughout the body, allowing for a smooth delivery of the active drug over 24 hours following a single dose of R-107.

In a gold-standard classic animal model of PAH, IM dosing of R-107 demonstrated pulmonary-selective vasodilation and a durable normalization of pulmonary blood pressure that persisted after the cessation of therapy. This latter effect, representing a stable reversal of established disease, is an unprecedented in vivo observation and suggests that R-107 may be able to stably reverse PAH in the clinical setting, a benefit that has eluded all of the existing group of approved PAH therapeutics.

Phase 1 Clinical Study to be Conducted by CMAX in Adelaide, Australia

CMAX, located in Adelaide, South Australia, is one of Australia’s largest and most experienced Phase 1 and Phase 2 clinical trial units. CMAX conducts successful world-leading research for Australian and international clients, specializing in a range of clinical trials and first-in-human studies.

CMAX will conduct a Good Clinical Practice (“GCP”) Phase 1a study of IM injectable R-107. The study is expected to begin enrollment in early Q3 this year, and will have a duration of two months. The study will enroll 32 healthy middle-aged volunteers in 4 ascending dose cohorts.

The study will be carried out under full GCP compliance, so that its results may be fully recognized and accepted by regulatory authorities at the FDA (USA), MHRA (the U.K.), EMEA (the EU), and TGA (Australia).

Funding for the Company’s Phase 1a clinical study at CMAX will be provided from an R&D expense refund that the Company expects to receive next month from the Australian Tax Office (the “ATO”). The ATO provides refunds of up to 43% of qualifying R&D expenditures, and this was a factor in the Company’s decision to conduct much of its research activities in Australia.

Phase 1 Study Data Intended to Support Follow-On Studies in PAH, COVID-19 Infection, and COVID-19 Related Sepsis

The Phase 1a study data are intended to be sufficient to support the Company’s planned follow-on proof-of-concept Phase 2a clinical study in treatment of severe pulmonary arterial hypertension (“PAH”) in patients undergoing cardiac catherization as part of their routine medical care. The Company expects to initiate this proof-of-concept Phase 2a clinical pilot study in early 1H 2022 in order to enable full characterization of the level of effectiveness of R-107 in patients with severe PAH prior to the end of 2022.

Following completion of the CMAX Phase 1a study, the Company plans to initiate a Phase 1b repeat dose study in Q4 this year. Data from this study are intended to support planned Phase 2a clinical studies in the treatment of COVID-19 infection, as well as COVID-19 related sepsis, each of which studies is expected to be initiated during 1H 2022.