Towards a cure for Mycobacterium abscessus disease using inhaled tigecycline

Roden — July 7, 2021Mycobacterium abscessus is a nontuberculous mycobacterium (NTM) that primarily causes severe pulmonary infections. The pathogen is also known as the ‘antibiotic nightmare’, due to its resistance to nearly all antibiotics. Following successful research into a potential treatment option, PureIMS, Radboudumc and Sever Pharma Solutions (until recently known as Disphar International) are now teaming up to develop an effective cure for this chronic and debilitating disease.

Worldwide, over 30,000 patients suffer from Mycobacterium abscessus disease. This number has been steadily rising in recent years, particularly among patients with Cystic Fibrosis. The infections caused by the bacterium can lead to a rapidly deteriorating lung function and shortened life expectancy. Up to this day, no effective cure for the disease exists.

Researchers at Radboud university medical center (Radboudumc) have shown that tigecycline – a decades-old antibiotic – is capable of defeating Mycobacterium abscessus. However, intravenous treatment with the necessary dose of tigecycline (200 mg/day) has severe side effects, including excessive vomiting, hepatic dysfunction and acute pancreatitis.

In order to overcome this obstacle, Radboudumc also researched inhaled administration of tigecycline. The initial results of this research are very promising: when delivered directly to the lungs via inhalation, a much lower dose of the antibiotic is required. This in turn drastically reduces the risk of unwanted side effects, opening up a path to a successful cure.

Research and development partnership

PureIMS, a clinical-stage pharmaceutical and medication systems company, and Sever Pharma Solutions, a pharmaceutical company with a track record in drug repurposing, have now joined forces with Radboudumc to take the next step. The three partners signed a letter of intent to jointly develop a tigecycline dry powder inhaler and ensure its successful registration and market introduction.

 “We are very excited to work on this promising research and development project in offering a treatment for patients suffering from NTM pulmonary disease, a true unmet medical need”, says Bram van Dijck, CEO of PureIMS. “The combined knowledge and expertise of the consortium will be very beneficial in carrying this project forward. PureIMS will start the feasibility work for inhaled tigecycline using its proprietary dry powder inhaler Cyclops™ and we expect to have initial results on the technical feasibility before the end of 2022”.

“The initial target of our partnership will be to set up the required studies, up to phase II and III”, says Jakko van Ingen MD PhD, head of mycobacteriology at Radboudumc. “This partnership and inhaled tigecycline have the capacity to finally develop effective treatments for this severe emerging infection”.

“Sever Pharma Solutions participates in collaborations like these, with the objective to make them available through registration and affordable prices. These inventions need to make it to the market, to become readily available for patients suffering from NTM pulmonary disease”, says Guido van der Aar, Site Manager for Sever Pharma Solutions in the Netherlands.

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Bram van Dijck- CEO

About PureIMS

PureIMS is a clinical-stage pharmaceutical and medication systems company focused on developing and commercializing innovative inhaled therapies for the treatment of systemic and respiratory diseases with significant unmet medical needs. Cyclops™ is an easy-to-use, pre-filled, disposable dry powder inhaler (DPI) that is developed for inhalation powders and can be produced in a cost-effective way because of its simple yet sophisticated proprietary design. Upon inhalation it uses the patient’s breath to disperse the dry powder formulation into small particles appropriately sized for deep lung deposition. Cyclops™ has several advantages compared to standard-of-care DPIs across key therapeutic areas. These attributes enable the hygienic and effective use on a worldwide scale.

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About Radboudumc

Radboud university medical center aims to be a front runner in the development of sustainable, innovative and affordable healthcare. To have a meaningful influence on healthcare in The Netherlands and the rest of the world. Or as we like to say: to have a significant impact on healthcare.

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About Sever Pharma Solutions (until recently known as Disphar International)

Disphar merged recently with a sister company into a new entity; Sever Pharma Solutions. We are a pharmaceutical company engaged in the development, registration, supply, marketing and commercialization of pharmaceutical products and specialize in drug repurposing. We are involved in more than 4 drug repurposing initiatives and play an active role in the public discussions regarding fair pricing of repurposed medicines.