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Significant figures

Insmed’s Olaf Bartsch tells PME about the US biotech’s year of progress

Olaf Bartsch

US biotechnology company Insmed enters 2018 in buoyant spirits after a pivotal 12 months that saw its lead product candidate begin to make good on its promise after a shaky start.

ALIS (Amikacin liposome inhalation suspension) is being developed as a treatment for refractory non tuberculous Mycobacterial (NTM) lung disease, a rare progressive, destructive infection caused by mycobacterium avium complex.

One of those at the forefront of the novel therapy’s progress on European shores is Insmed’s vice president Europe and general manager Germany Olaf Bartsch.

“Last year was one of the most significant years for Insmed,” Olaf tells PME, adding: “It was a big step forward to becoming a commercial company which is very important for us.”

An inhaled formulation of last-resort antibiotic Amikacin, ALIS taps into a need for new antibiotics as well as industry heads towards more joined-up thinking to tackle antimicrobial resistance. US regulators at the FDA have recognised the treatment’s potential, handing it breakthrough and fast-track status.

It all seems a long way from 2014’s disappointing news for the biopharma when ALIS failed to meet its primary endpoint in a phase II trial. Fast forward to last September and the company’s decision to put ALIS through phase III trials paid off, when it released late-stage results showing 29% of patients with NTM lung diseases demonstrated complete eradication compared to only 9% of patients on placebo.

Next stop - awareness

When news of the global CONVERT study broke, shares in the company skyrocketed - however the work had only just begun for Insmed.

“Our priorities now are to increase disease awareness and medical education on NTMs,” continued Olaf. “We want to help various European healthcare systems establish a treatment infrastructure for patients with NTM, because many are not being treated regularly by NTM experts.”

NTM is a rare progressive, destructive infection that’s normally found in addition to pulmonary diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis or bronchiectasis. It’s associated with a multitude of symptoms, such as fatigue, fever, weight loss, cough and lack of appetite.

However, the issue that’s concerning NTM experts across the globe is that a current therapy used for treating such pulmonary diseases, specifically bronchiectasis, can make NTMs resistant to current treatment.

“If a physician wants to initiate a long-term, macrolides-based monotherapy in bronchiectasis patients for example, then they should first perform an NTM test, otherwise the NTM bacteria can easily develop resistance to the macrolide antibiotic, which is one of the most powerful weapons the physician has to treat NTM disease.”

Offering an on-label treatment

The current standard of care for treating patients with NTM lung disease consists of a triple antibiotic therapy for 18 months, but it is used “more or less off-label as it’s not specifically indicated to treat the disease”, Olaf explains.

“Another issue surrounding the diagnosis of NTMs is that physicians can be hesitant to prescribe such a cumbersome treatment with a relatively low compliance rate to their patients, many of whom are elderly and former smokers. Placing them on such a treatment regimen puts a lot of burden on both the patient and the physician.”

However, Insmed believes ALIS “has the opportunity to dramatically improve the treatment of NTM lung disease”. Its novel therapy is an inhaled formulation of Amikacin that is delivered via Insmed’s pulmonary liposome technology directly to where the NTM infection resides. The company hopes the novel therapy and its delivery method could be a potential game changer in the field of antibiotic resistance. The liposome technology creates a shield that keeps most of the drug out of direct contact with a patient’s blood, successfully dodging Amikacin’s severe side effects, which include deafness, kidney toxicity and paralysis.

“European physicians welcome the development of new antibiotics. Key opinion leaders will explain to some extent how desperate the antibiotic resistance situation is, especially with older medication. Additional resources such as scientific education are also important to fully understand the antibiotic resistance urgency, but I think this is an issue that is already being addressed. But we have a real under-diagnosis problem in Europe when it comes to NTM disease and patients are currently in a miserable situation, which is why our main focus as a company right now is our NDA filing of ALIS in the US.”

Olaf said that ALIS’ second NDA filing will most likely be in Japan due to its big NTM population and the regular frequency of physicians testing for NTM disease in patients.

After that the company will train its focus more fully on Europe, NTM diagnosis levels and beginning the EU filing process once the study’s full results become available.

Article by
Gemma Jones

26th February 2018

Article by
Gemma Jones

26th February 2018

From: Research



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