Cystic Fibrosis (“CF”) is a chronic genetic illness affecting the lungs and digestive systems of approximately 75,000 children and adults worldwide. In the USA, the average life expectancy of a person with CF is around 37 years1. CF qualifies as an “orphan disease” under the Food and Drug Administration (“FDA”) drug development framework, which allows for faster and lower cost medicine development. Breathe Easy Limited (“Breathe Easy”) is developing an inhaled medicine called Citramel™. It is expected to be positioned as a core therapy to improve lung function and to potentially enhance the effectiveness of other inhaled CF therapies such as antibiotics. Citramel™ addresses an estimated US$1 billion market2.
Citramel™ has been developed by Professor Bob Elliott, inventor and founder whose research also started Living Cell Technologies (ASX:LCT) and Somnaceutics (start-up to exit in 3 years).
This is New Zealand’s first wholesale investor / equity crowdfunding co-investment opportunity. Breathe Easy is seeking $2 million, of which it has already raised over $1 million from the NZ angel investor community, Pacific Channel, and the New Zealand Venture Investment Fund (NZVIF). Breathe Easy now seeks to raise up to $700,000 through Snowball Effect in order to conduct certain activities, principally an approved Phase I/IIa (an early stage trial that tests both safety and efficacy in humans) clinical trial of Citramel™ in New Zealand in healthy volunteers and those with CF. Resources permitting, Breathe Easy intends to evaluate other medical applications for Citramel™ and additional projects relating to CF.
A CF patient has been supplied with Citramel on a compassionate case basis for two years. No issues have been experienced by the patient, a noticeable thinning of normally thickened mucus has been reported and an increase in lung function has been observed. While taking Citramel this person also became free of a persistent mucoid Pseudomonas - a major cause of death in CF patients - after 9 years of unsuccessful treatment by a range of antibiotics alone.
This offering is a unique opportunity for Kiwis to invest in a New Zealand developed trial medicine that has the potential to greatly improve the lives of those with CF worldwide. If successful, Breathe Easy is likely to become significantly more valuable.
 Cystic Fibrosis Foundation, cff.org/AboutCF/
Those with CF typically suffer compromised lung function due to the formation of thick sticky lung mucus which clogs the small airways and causes recurrent infections and lung damage. The presence of thickened mucus, coupled with the biofilm and inflammation from bacterial infections, block the entry of both antibiotics and elements of the patient’s own immune system. If this biofilm could be removed, it is expected that a patient’s lung function would improve and existing antibiotics would be more effective.
Citramel is a liquid formulation delivered by nebuliser and inhaled into the lungs of those with CF. In vitro, Citramel has been shown to disrupt biofilms which is a contributing factor to the thick mucus and infections in CF lungs. As such, Citramel will be a mucus alteration agent, which is intended to improve breathing and the effectiveness of certain antibiotics. A small part of Breathe Easy’s budget has been allocated to exploring other medical applications for Citramel and other therapies and monitoring devices for CF and respiratory diseases with similar issues such as Chronic Obstructive Pulmonary Disease (“COPD”). This strategy may provide product development opportunities in larger markets. Breathe Easy may license to or partner with larger medical development companies to pursue such new product development opportunities.
CF is a chronic genetic illness diagnosed at birth. It primarily affects those of Caucasian descent and there is currently no cure. People with CF require lifelong treatment and medical support. Typically they have decades-long relationships with the same specialists. To reach these patients, it will be necessary to engage with CF tertiary care providers, support organisations, insurers, national medicine regulators and pharmaceutical bodies. In major markets such as the US, there is a single national support organisation and a small number of CF medical specialists. This structure makes CF a well connected and readily addressable market.
CF is a complex illness with a treatment focus on easing symptoms and reducing complications. In addition to regular chest wall percussive physiotherapy, existing medications broadly centre on preventing and controlling lung infections with bronchodilators, antibiotics, and mucus thinning agents to loosen and remove mucus in the lungs. Nutrition is improved with supplementary pancreatic enzymes and vitamins. More recently, gene specific small molecule medicines have been developed that target some of the less common CF gene mutations. Even with these very expensive new medicines, (such as Kalydeco, which can cost US$368,000 per patient per annum) those with CF are still vulnerable to bacterial lung infections, although to a lesser extent. Breathe Easy anticipates that Citramel might therefore be a complementary therapy to such medicines.
Citramel is believed to work as a mucus thinning agent and as has already been mentioned it could be co-administered with other agents affecting mucus such as antibiotics and other therapies in development. A medication already available but with a different mode of action and affecting different aspects of mucus is Genentech’s Pulmozyme®. This medicine reduces the presence of excess extracellular DNA. Hypertonic saline is also available and is thought to improve hydration of the airways. Citramel has a different and potentially synergistic action to both of these medications. When infections occur, inhaled therapies prescribed for the treatment of pseudomonas aeruginosa ("Pseudomonas") and other pathogenic infections include antibiotics such as TOBI®, Cayston® and Azithromycin or Zithromax®. Citramel is believed to increase the susceptibly of bacterial infections to treatment with certain such antibiotics, through disrupting biofilms and thinning secretions. Breathe Easy aims to capture significant market share with Citramel being a broadly useful, daily administered product with minimal side effects. The advantages are expected to include:
Breathe Easy’s strategy is to:
Due to the nature of the stepwise process of medicine development, with positive clinical data at the end of each trial phase, there could be an opportunity to realise value by selling the assets or the Company early.
Management of Breathe Easy
The three members of the Breathe Easy management team have varied backgrounds, qualifications and experiences however each has personal knowledge and experience of CF. The team believes Breathe Easy can contribute to the worldwide fight to improve treatments and develop therapeutics which will increase the life expectancy and improve the quality of life of those who suffer from not only CF, but other lung disorders.
Clinical Trial Personnel
The trial programme will be undertaken in Christchurch utilising the Christchurch Clinical Study Trust facilities with CF volunteers coming from the Canterbury region. The trial medical and technical specialist personnel are all based in the Christchurch area.
It's crucial for you to understand the characteristics and risks of this investment opportunity. New Zealand law normally requires people who offer financial products to provide in-depth information to investors before they invest. The usual rules do not apply to offers by companies through Snowball Effect. As a result, you may not be given all the information you need to make an informed decision. Investing is risky. Some of the key risks include loss of capital, illiquidity, lack of returns, dilution, loss of key people and customers, and lack of control. You should only invest money that you can afford to lose.