Startup driving cystic fibrosis drug to market

Andrea Miller is used to facing tough situations. As a senior army officer for 22 years, she’s faced all sorts of challenges, including a UN peacekeeping tour to East Timor. Now, as the chief executive of Auckland-based startup company Breathe Easy, she’s fighting for the 75,000 people around the world who suffer from cystic fibrosis (CF), including her 26-year-old daughter, Sarah.

CF is a chronic genetic illness that affects the lungs and digestive system. It’s debilitating and destructive, says Miller. “It’s a tough foe. Sadly the prognosis is really grim.

“It’s improving now, but the average life expectancy is still only in the 30s.”

Sufferers have thick and sticky mucus in their lungs, which settles and clogs the small airways and causes recurrent lung infections.

Miller’s partners in Breathe Easy are Professor Bob Elliott, who Miller first met more than two decades ago when he was her daughter’s paediatrician, and Auckland-based life sciences investor and champion Brent Ogilvie.

Through years of self-education, attending overseas medical conferences and completing an internship with the Cystic Fibrosis Foundation in the US, she’s gotten to know Elliott and Ogilvie pretty well, she says.

Breathe Easy came about after Professor Elliott invented a new drug called Citramel, which melts the biofilms or mucus obstructing the effectiveness of existing antibiotics and the patient’s own immune system in dealing with CF.

With the backing of Ogilvie’s life science investment company Pacific Channel, Ogilvie and Elliott formed Breathe Easy to develop Elliott’s findings into a useable product and bring it to market with Miller’s help.

Since then Breathe Easy has gained regulatory and ethical approvals for the crucial Phase I/IIa clinical trial to test its efficacy and safety. The trial is due to start in early 2015 at the Christchurch Clinical Studies Trust.

It’s potentially a huge breakthrough for the medical world and an important milestone for New Zealand’s medical innovation as this will be the first CF product to enter clinical trials that was invented here and will be manufactured here. “At Pacific Channel we look for both a high potential social good as well as high potential financial returns and Breathe Easy embodies both, very much,” says Ogilvie.

Pacific Channel and its network of angel (early-stage) investors have already pumped in “a few hundred thousand dollars” to get to this stage, says Ogilvie, but Breathe Easy needs another $1.5 million to complete the clinical trial to test Citramel and move the product forward.

It’s a lot of money, but the task is a little less daunting because CF is classified as an “orphan” disease – a disease that affects only a relatively small percentage of the population – and as such can get fast-track approval with important international regulators such as the US Food and Drug Administration (FDA).

“Drug development is tough, and doing it from New Zealand is very tough. However, the beauty of working on an orphan drug, where the market for the number of patients is obviously much smaller than something like heart disease, for example, allows for faster and lower-cost drug development,” said Ogilvie.

Running the clinical trials in New Zealand is also a lower-cost alternative to conducting the trials in Europe or the US, plus it has the added benefit of spreading knowledge and awareness about CF and the treatment possibilities among New Zealand’s medical fraternity, says Miller.

Breathe Easy also believes that Citramel may benefit those with diseases such as chronic obstructive pulmonary disease, which affects around 330 million people, so the potential is enormous, she adds.

“It’s a sensational story! Rather than the awful situation of having to sit and wait for the illness to take its toll, here we are getting up, taking action, and developing a medication that could be really helpful in the fight against CF.”

Produced in conjunction with the Angel Association of New Zealand.

First published on Thursday Sep 25, 2014

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