Delivery via inhaler could dramatically expand Amikacin’s clinical utility by immediate reduction of the contagiousness of Mycobacterium tuberculosis.
Roden — July 1st, 2020 — PureIMS, a clinical stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory and systemic diseases, announces today the initiation of a Phase 1 clinical trial to evaluate the pharmacokinetic (PK) profile, efficacy and safety of Amikacin Cyclops™ – an amikacin dry powder inhaler (DPI) – in patients with Drug Susceptible Tuberculosis (DSTB).
Amikacin is a second-generation aminoglycoside antibiotic, and is currently in development for the early eradication therapy of TB in combination with an oral maintenance antibacterial drug regimen.
This open label, ascending dose study with the Amikacin Cyclops™, which is conducted together with the Tuberculosis Center of the University Medical Center Groningen at Beatrixoord and the University of Groningen, will enroll 8 TB patients. The objectives of the study are to evaluate the PK profile following single escalating doses of amikacin when administered by Cyclops™ DPI and to evaluate the safety and tolerability of single doses of amikacin administered by Cyclops™ DPI. Data from the study are expected during the second half of 2020.
Inhaled amikacin has been studied via the nebulized route of administration and is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Mycobacterium avium complex (MAC) lung disease. It is part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. Studies have shown that inhaled amikacin is well tolerated.
“Positive results using inhaler formulations could dramatically expand amikacin’s clinical utility by immediate reduction of the contagiousness of Mycobacterium tuberculosis.” says Onno Akkerman, MD, PhD, the principal investigator of the trial and renowned TB investigator. “We believe it is important to understand how amikacin works via the Cyclops™ delivery platform in order to fully realize and leverage its clinical potential for patients with TB.”
TB is the leading infectious disease killer in the world, claiming 1.5 million lives each year. Although TB is thought to be underdiagnosed, globally, around 10 million people become ill with TB each year. This number, according to the World Health Organization, is likely to decrease in coming years, with the goal to eliminate TB as a public health problem by 2050. To achieve this goal, there is an urgent need for drugs with novel mechanisms of action and/or delivery routes that can be used by these patients in addition to current therapies.
About PureIMS, Cyclops™ and Amikacin
PureIMS is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory and systemic diseases with significant unmet medical needs. PureIMS’ product candidate, Amikacin Cyclops™, is a second-generation aminoglycoside antibiotic, and is currently in development for the early eradication therapy of TB in combination with an oral maintenance antibacterial drug regimen. The Cyclops™ DPI is an easy-to-use, pre-filled, disposable DPI that is developed for high-dose drugs and cheap to produce because of its simple yet sophisticated design. Upon inhalation it uses the patient’s breath to circulate and disperse the dry powder formulation into small particles appropriately sized for inhalation. Cyclops™ has several advantages compared to standard-of-care products across key therapeutic areas. These attributes enable the hygienic and effective use on a worldwide scale.
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