Levodopa Cyclops™ is a levodopa dry powder inhaler for the fast and reliable relief of OFF episodes in Parkinson’s disease. As such, Levodopa Cyclops™ answers a major unmet medical need.
Levodopa is the cornerstone in the treatment of Parkinson’s disease for well over 50 years. It is the most effective, safe and well tolerated drug available to this end. However, patients suffering from Parkinson’s disease invariably will encounter a major unmet medical need as the disease progresses:
- Patients in mid- and late-stage disease suffer from variable therapeutic efficacy, which results in periodic motor-fluctuations (ON and OFF episodes).
- Patients with acute OFF episodes need fast and reliable rescue therapy to be able to participate in daily activities.
- Currently available medication either has a slow or unpredictable onset of action or is poorly tolerated and uncomfortable to use.
Inhaled levodopa from the Cyclops™ offers Parkinson’s disease patients easier and more convenient handling, a faster onset of action and more flexible dosing than other treatments to counteract OFF episodes.
Studies showed that Parkinson’s disease patients are able to readily use Levodopa Cyclops™ during an OFF episode. Inhaled levodopa from the Cyclops™ results in a peak plasma concentration within minutes and its absorption is less variable than that of oral levodopa, both of which are prerequisites for the rapid and predictable relief of OFF episodes.
Epinephrine Cyclops™ is an epinephrine dry powder inhaler for the fast and reliable treatment of severe allergic reactions and anaphylaxis. Inhaled epinephrine from the Cyclops™ offers people at risk of anaphylaxis a low barrier to use, because it is non-invasive, easy and convenient to handle, it has a fast onset of action, and a short exposure duration which allows for repeated treatment without dose stacking.
The current first-aid treatment to prevent anaphylaxis is intramuscular epinephrine injection by means of an autoinjector. Major unmet medical needs experienced by people at risk of anaphylaxis are the following:
- People are reluctant to use their autoinjector, which puts them at risk of untimely treatment of an anaphylactic reaction.
- Fewer than 50% of people at risk of anaphylaxis can use their autoinjector device correctly. An easier-to-use device for epinephrine administration is therefore required.
Epinephrine Cyclops™ answers both medical needs with its ease and convenience of use.
A clinical study showed that Epinephrine Cyclops™ results in a shorter and less variable time to peak plasma concentration than intramuscular epinephrine. The exposure duration following the use of Epinephrine Cyclops™ is also very brief and consistent, which results in a plasma profile that approaches intravenous epinephrine.
Colistin Cyclops™ is a pre-filled colistin dry powder inhaler for the treatment of pulmonary Pseudomonas aeruginosa infections in cystic fibrosis and bronchiectasis. It offers a more patient-friendly alternative to other methods of administering colistin, because it is easy to use, easy to carry, pre-filled and disposable (no cleaning required!).
Inhaled colistin is a safe and effective treatment for (chronic) infections of the lungs with Pseudomonas aeruginosa. To date, inhalation of colistin by nebulization has been a very time consuming endeavour, whereas colistin dry powder inhalation from capsule based inhalers often results in pronounced cough. Colistin Cyclops™ offers a fast and convenient alternative to colistin inhalation.
Since 2015 Colistin Cyclops™ (and its precursor Colistin Twincer™) are available in the Netherlands for compassionate use. More information about our Colistin Cyclops™ compassionate use program and the experience of patients and health care providers with Colistin Cyclops™ will follow soon.
Pulmonary Pseudomonas aeruginosa infections may be treated by continuous alternating therapy with inhaled colistin and inhaled tobramycin. Therefore, in addition to Colistin Cyclops™, PureIMS also develops Tobramycin Cyclops™, a tobramycin dry powder inhaler. This offers patients the ease and comfort of use of the Cyclops™ throughout their continuously alternating treatment cycle.
Amikacin Cyclops™ is an amikacin dry powder inhaler for the treatment of tuberculosis (TB). Inhaled amikacin from the Cyclops™ will result in higher amikacin concentrations in the lungs than conventional infusion or intramuscular injection. This could more rapidly decrease contagiousness by sterilizing the upper airways of patients with ’open’ (smear positive) TB, potentially even of otherwise drug resistant TB. In addition, Amikacin Cyclops™ offers TB patients an easier and much more convenient administration than infusion or injection. A fast reduction of contagiousness and new, less toxic drug regimens with a shorter duration will prevent long hospital admissions and thereby help to reduce healthcare costs.
Amikacin is an approved drug for the treatment of and non-tuberculous mycobacterial infections. Amikacin is not absorbed via the gastrointestinal tract, which makes its oral administration impossible. TB is the world’s most common infectious disease that caused a staggering 1.4 million deaths in 2019 (WHO). Therefore, stopping the spread of TB and improving its treatment are urgently required. Inhaled, more targeted treatment with inhaled amikacin from the Cyclops™ may aid in battling the often-unrecognized humanitarian disaster TB causes on a global scale.
An open-label Phase 1 clinical trial with Amikacin Cyclops™ in TB patients is currently ongoing to determine its pharmacokinetics and local tolerability.
PureIMS aids in the fight against corona virus by developing Hydroxychloroquine Cyclops™, a hydroxychloroquine dry powder inhaler for the fast and convenient treatment of SARS-CoV-2. Hydroxychloroquine (HCQ) is effective against many viruses, including SARS-CoV-2, and is an approved drug for the treatment of malaria and several autoimmune diseases. HCQ Cyclops™ presents the promise of a more effective and safer alternative to oral HCQ, because inhaled HCQ will result in higher, more effective HCQ concentrations in the lungs at lower, less toxic doses.
Hydroxychloroquine Cyclops™ is expected to be a powerful therapy especially in the early stages of infection. It is a credit card sized, portable, widely distributable, hygienic, easy-to-use inhaler. Non-invasive, inhaled administration enables early intervention in any kind of outpatient setting.
An open-label Phase 1 clinical trial with HCQ Cyclops™ showed that 5, 10 and 20 mg of inhaled hydroxychloroquine does not lead to measurable plasma concentrations, which emphasizes the strong case for inhaled HCQ to prevent serious systemic side-effects often related to oral HCQ. Furthermore, it is well tolerated with a bitter taste as the most common but surmountable adverse effect. Please click the link to the (non-peer reviewed) preprint report of this study at MedRxiv.org for more information about the tolerability and pharmacokinetics of inhaled hydroxychloroquine from the Cyclops™.
Mannitol Cyclops™ is a mannitol dry powder inhaler for bronchoprovocation testing. Mannitol is an indirect stimulus used to assess airway reactivity. Mannitol Cyclops™ is a tool to identify bronchial hyperresponsiveness, a key clinical feature of respiratory conditions such as asthma. Reproducible emission and dispersion of the mannitol dose by the Cyclops™ enables accurate and reliable determination of airway hyperresponsiveness and, with that, asthma diagnosis. Its ability to disperse high doses will limit the number of inhalations required during the test, which makes it faster and more convenient.
Mannitol Cyclops™ is currently in the preclinical development stage.