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LATITUDE Pharmaceuticals Develops an SC/IM Injectable Remdesivir Formulation

100 mg/mL Formulation Offers Significant Advantages for Dosing COVID-19 Patients

SAN DIEGO, CALIFORNIA, US, May 5, 2020 / -- LATITUDE Pharmaceuticals Inc. (LATITUDE), a specialized drug formulation developer, announced today that it has developed a new injectable formulation for remdesivir and will make it available to researchers interested in utilizing the company’s new formulation in the fight against the SARS-CoV-2 coronavirus responsible for the COVID-19 pandemic.

Remdesivir is a novel antiviral drug with proven effectiveness against certain coronaviruses that has recently been granted an emergency use authorization by the FDA for treating COVID-19 patients. Since remdesivir is insoluble in water, the current remdesivir drug formulation uses a cyclodextrin to dissolve remdesivir for administration by intravenous (IV) injection. Since this cyclodextrin can only dissolve remdesivir to about 5 mg/mL, the current formulation ends up in a large volume; e.g., 20 mL or more for the 100 mg remdesivir daily dose. This cyclodextrin-enabled formulation also requires further dilution with saline or dextrose solution and can only be given to patients by a 30-120 minute intravenous (IV) infusion in a hospital setting.

LATITUDE has applied its proprietary drug solubilizing vehicle ClearSol™ to dissolve remdesivir to the much higher concentration of 100 mg/mL, which would reduce the 100 mg dose volume to about 1 mL. Such a small-volume formulation has the potential to be administered using faster and more convenient subcutaneous (SC), intramuscular (IM) or IV bolus injection in an outpatient setting, which would free up valuable hospital resources during the current COVID-19 crisis.

ClearSol™ may be provided alone as a sterile vehicle (i.e., ready to dissolve a drug) or as a premixed solution containing a drug. For remdesivir, use of the ClearSol™ vehicle could allow a nurse, physician or compounding pharmacist to rapidly dissolve remdesivir, enabling the bedside preparation of a dosing solution at a variety of desired dosing strengths.

“LATITUDE is offering its ClearSol™-remdesivir formulation to the medical and pharmaceutical industries as a potentially valuable pharmaceutical tool in combating COVID-19,” noted Andrew Chen, LATITUDE’s President. “We believe its immediate utility could relieve potential drug shortages by providing a low-cost new formulation option for antiviral drugs. In our experience, ClearSol™ has been the most broadly applicable, effective and safest solubilizer, suitable for a wide range of highly insoluble drug compounds. We encourage researchers to use it for their insoluble drugs.”

About ClearSol™
ClearSol™ is a stable aqueous solubilization vehicle that combines three key FDA-approved injectable excipients in a proprietary composition to provide extraordinary drug-solubilization activity. The vehicle’s safety has been established in numerous animal studies and in a US Phase 1 human clinical trial. ClearSol™ has solubilized about 80% of highly insoluble drugs to adequate concentrations for their dosing by injection. In comparison, a leading commercially available cyclodextrin solubilizer only solubilized about 20% of these same drugs. Furthermore, in a preclinical safety study, after 28 days of daily intravenous dosing in rats, ClearSol™ did not cause any observable histopathological effects on kidney, liver, lung or pancreas, whereas this same cyclodextrin solubilizer caused vacuolation in kidney tubules.

About LATITUDE Pharmaceuticals Inc.
LATITUDE is a leading developer of innovative drug formulations and drug delivery systems for out-licensing to the biotech and pharmaceutical industries. The company is highly regarded for its intellectual property portfolio and innovative approaches to developing pharmaceutical formulations for problematic and/or highly insoluble drug molecules.

For more information about LATITUDE’s remdesivir formulation or the ClearSol™ technology, please contact LATITUDE.

+1 858-342-2065
Matthew A. Singer, PhD
LATITUDE Pharmaceuticals Inc.
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