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Claritas Pharmaceuticals has received comments from the Australian Human Research Ethics Committee regarding its Phase 1 clinical study of R-107, which aims to treat conditions like pulmonary arterial hypertension. The company plans to respond to these comments soon and anticipates final approval for the study shortly thereafter. The Phase 1 trial will assess the drug's safety and pharmacokinetics, enrolling 40 participants. Following this, multiple Phase 2 studies are planned. Claritas has closed a CAD $150,000 financing tranche to support the upcoming clinical study.
Claritas Pharmaceuticals announced that the Australian Human Research Ethics Committee (HREC) will review its submission for the Phase 1 clinical study of R-107 on February 16, 2022. Approval is expected by February 18, 2022, allowing immediate enrollment of 40 subjects in the study assessing R-107's safety and tolerability. Following this, multiple Phase 2 studies will target conditions like pulmonary arterial hypertension and COVID-related complications. R-107 shows promising results in animal studies, supported by U.S. government funding.
Claritas Pharmaceuticals (KALTF) has revised the pricing for an equity financing agreement with Alumina Partners. The initial tranche of CAD $150,000 will now see 1,081,081 units issued at CAD $0.13875, reducing dilution by over 250,000 shares. The warrant's exercise price is increased from CAD $0.1875 to CAD $0.21. The funds will mainly support the remaining costs of a Phase 1 clinical study of R-107, expected to conclude in Q1 2022. The agreement is subject to TSX Venture Exchange approval.
Claritas Pharmaceuticals has signed a Letter of Intent with the Salzman Group for an exclusive worldwide license to develop and commercialize R-107 for treating skin ulceration and wounds, particularly severe burns. R-107 is a nitric oxide-releasing molecule with potential to become a revolutionary treatment. Claritas aims to apply for Orphan Drug Designation and plans to initiate a Phase 2a Clinical Study in pediatric patients in the second half of 2022. The annual market for effective burn treatments could exceed $1 billion.
Claritas Pharmaceuticals has entered into a two-year agreement with Alumina Partners for up to $5 million in equity financing. This funding will primarily support the Phase 1 clinical study of R-107, expected to conclude in Q1 2022, as well as future Phase 2a studies for pulmonary arterial hypertension (PAH) and persistent pulmonary hypertension of the newborn (PPHN). The financing structure aims to minimize shareholder dilution by allowing the company to draw funds as needed, at a discount from market prices. Claritas will also pursue additional funding from BARDA for R-107's COVID-related applications.
Claritas Pharmaceuticals (KALTF, CLAS.V) announced its development strategy for R-107, a nitric oxide-releasing compound, targeting multiple clinical indications. Key milestones include a Phase 1 clinical study set for completion in Q1 2022, followed by several Phase 2 studies later in the year. R-107 shows promise for treating COVID-related sepsis, ARDS, PAH, and PPHN, with potential grant funding to support these trials. The global market for sepsis treatment is projected to grow from $600 million in 2020 to $1.6 billion by 2031. R-107 may also target skin ulcers and wound healing.
Claritas Pharmaceuticals (KALTF, CLAS.V) announced the development of R-107, targeting persistent pulmonary hypertension of the newborn (PPHN). This condition affects 1 in 500 live births, leading to severe outcomes including death and long-term impairments. R-107 aims to outperform the current treatment, inhaled nitric oxide (iNO), which is ineffective for nearly 50% of patients due to iNO resistance. Claritas intends to initiate a Phase 2 study by the end of 2022, focusing on R-107's dual action as a nitric oxide releaser and oxidant degrader, potentially positioning it as a new frontline therapy.
Claritas Pharmaceuticals has announced a License Amendment granting exclusive global rights to develop R-107 for treating pulmonary diseases, including pulmonary arterial hypertension (PAH) and persistent pulmonary hypertension of the newborn (PPHN). The company expects to launch a Phase 2a study for PAH by Q3 2022. The market for PAH treatments is currently over $6 billion annually, projected to increase to $9.8 billion by 2027. R-107 shows significant promise in reversing PAH in animal models, which could position it as a best-in-class therapy.
Claritas Pharmaceuticals has announced the initiation of Phase 2 clinical testing for R-107, a nitric oxide-releasing compound, for the treatment of COVID-related sepsis, following a successful Phase 1 study. A peer-reviewed article in Scientific Reports highlights that R-107 significantly preserved multi-organ function and reduced mortality in a sheep model of sepsis. The global sepsis treatment market is valued at over USD $600 million and expected to reach USD $1.6 billion by 2031. Claritas plans to apply for grant funding to support further studies.
Claritas Pharmaceuticals, Inc. (OTC: KALTF, TSX VENTURE: CLAS) announced a change in its Phase 1 clinical study of R-107 due to delays at CMAX Clinical Research. The company has terminated its agreement with CMAX and signed a new contract with Scientia Clinical Research in Sydney, Australia, which has the requisite expertise to complete the study by the end of Q1 2022. The decision was influenced by the Australian Taxation Office's R&D rebate program. Following the Phase 1 completion, Claritas plans to launch a Phase 2a study targeting pulmonary arterial hypertension (PAH) and seek U.S. grant funding for COVID-related lung disease development.
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