Breathe Easy

Breathe Easy is an Auckland and Christchurch-based startup that is developing Citramel™, an inhaled medicine for the treatment of Cystic Fibrosis, a chronic genetic illness affecting the lungs of approximately 75,000 children and adults worldwide.

Minimum investment: $1,000.00

$613,428
Funded
Min target: $350,000 (6.67% equity) Max target: $700,000 (13.31% equity)
Ended Mon, 18 May 2015 9:00pm (NZST)
155 Number of investments
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$613,428 Funded
$350,000 Min target (6.67% equity)
$700,000 Max target (13.31% equity)
$0 Still available for investment
Offer closed Mon, 18 May 2015 9:00pm

Executive summary

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.


[1] Cystic Fibrosis Foundation, cff.org/AboutCF/
[2]researchandmarkets.com/research/8xz4rj/cystic_fibrosis

Customer need


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.

The product


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.

The target market

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.

Current CF treatments

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.

Competitive Advantage

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:

  • Citramel being effective in improving lung function on its own.
  • Citramel being composed of ingredients currently used in human medicines/foods with toxicity expected to be low. The New Zealand regulator has already approved its use in a clinical study.
  • Citramel is expected to qualify for the FDA’s “orphan disease” expedited medicine development program, which has a shorter and less expensive pathway to market relative to most medicines.
  • Citramel having a low cost of production and therefore could be priced competitively if required.
  • Citramel being complementary to existing and future CF therapies (i.e. other mucus thinning agents, anti-infectives and other modes of action) to further improve lung function and reduce lung infections.
  • Citramel having the potential for widespread use in CF patients since it addresses the common CF symptom of thickened lung mucus.

Business Model


Breathe Easy’s strategy is to:

  1. Focus on Citramel as a high margin, high volume product. 

  2. Conduct a Phase I safety trial in New Zealand with 5 (healthy volunteers) immediately 
followed by a Phase IIa indicative efficacy trial of approximately 25 CF patients.
  3. Seek a finding of acceptable safety and tolerability of Citramel as well as “indicative 
efficacy” in treating CF patients. 

  4. Qualify for FDA “orphan drug” classification which offers a shorter, cheaper route 
to approval. If achieved, this will enable further capital raising for subsequent clinical trials. Phase IIb and Phase III trials would be required before therapy sales (see ‘Strategy Options’ below).

  5. Breathe Easy or its assets could be positioned for sale to a larger biotechnology or pharmaceutical company after the successful completion of a Phase I/IIa, Phase IIb or Phase III trials or the shareholders via their director representatives may elect to continue development.

Strategy Options

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.

Photo of John Langlands  – PhD, Respiratory Pharmacology

John Langlands – PhD, Respiratory Pharmacology Toxicology Advisor

John is based in Canada and is responsible for writing the pre-clinical documents for Citramel as well as the Investigators Brochure. John is experienced in preclinical and clinical translational medicine approaches to drug development as well as the formulation and review of documentation to support submissions to regulatory agencies including FDA.
Photo of Michelle Lockhart  – BPharm, MMgt, PhD

Michelle Lockhart – BPharm, MMgt, PhD Project Manager

Michelle has worked in the pharmaceutical industry for more than 25
 years and provides consultancy services including protocol preparation, Case Report Form design, ethics and regulatory applications and associated documents, standard operating procedures, monitoring and study management. Michelle is the trial safety officer.
Photo of Associate Professor Christopher Frampton  – BSc (Hons) PhD (Cant)

Associate Professor Christopher Frampton – BSc (Hons) PhD (Cant) Biostatistician

Chris Frampton is a biostatistician at the University of Otago (Christchurch) and is involved in departmental teaching and the design and analysis of research studies. His particular research interests include the modelling and prediction of long-term outcome data, and developing structural equation models for defining personality constructs. Chris is also the biostatistician for the New Zealand CF patient registry PORT CF.
Photo of Dr Chris Wynne  – MB ChB, FRANZCR, FAChPM, DipPharmMed

Dr Chris Wynne – MB ChB, FRANZCR, FAChPM, DipPharmMed Principal Investigator

Chris is an oncologist with 20 years of experience working in Australia,
 the UK, Singapore and New Zealand. In addition to his clinical role at St George’s Cancer Care Centre, he is a member of the Multi Region Ethics committee. His research experience includes principal investigator status on many clinical trials and participation in investigator initiated and cooperative group studies. He has an interest in health technology assessment and trial design and in 2011 earned the Graduate Diploma in Pharmaceutical Medicine from The University of New South Wales, Sydney, Australia.
Photo of Brent Ogilvie  – BSc. (Bio.), MBA

Brent Ogilvie – BSc. (Bio.), MBA Director

Brent Ogilvie is co-founder of Pacific Channel Limited, New Zealand’s leading venture creation, development and investment firm focused on start-up and early-stage life-science innovation. Pacific Channel is a seed co-investment partner of the New Zealand Venture Investment Fund. Through Pacific Channel’s activities as a seed investor Brent serves as a Director of Footfalls and Heartbeats Limited, D’Arcy Polychrome, Engender Technologies, Living Green and SciTOX Limited. Brent is also a Director of Somnaceutics Limited (now called S 1 Limited) and was also a Director of Ecodiesel Limited (now struck off), which sold their business assets to New Image Group (NEW:NZX) and Z Energy respectively. Brent was previously New Zealand Consul and Trade Commissioner to New York and has a nephew with CF.
Photo of Professor Robert Elliott – MBBS, MD, FRACP

Professor Robert Elliott – MBBS, MD, FRACP Chief Scientific Advisor and Director

Professor Bob Elliott is the creative force behind Breathe Easy. His discovery of Citramel’s ability to dissolve biofilms, combined with his awareness of the pathogenesis of CF, led him to see its future role in CF treatment. His many career highlights include the following: • Co-founded New Zealand based Living Cell Technologies (ASX:LCT) in 1987, and inventor and co-founder of Somnaceutics’ science and intellectual property (Somnaceutics’ business assets were sold to New Image Group Limited (NZE:NEW) in December 2010) • Foundation Professor, Department of Paediatrics at The University of Auckland and 
current Emeritus Professor of child health research 
 • World leader in diabetes and autoimmune related research 
 • Board member of the New Zealand Child Health Foundation 
 • Companion of the New Zealand order of Merit for services to the community 
 • Patron of the CF New Zealand association 
 • Inventor of the world standard new-born screening diagnostic test for CF, which is still 
used throughout the world some 30 years after its discovery 
 • Has been a paediatrician to many CF patients over the course of a multi-decade career as a 
medical doctor
Photo of Andrea Miller – ED, BBS, PG Dip

Andrea Miller – ED, BBS, PG Dip CEO

With an interest and involvement in CF for over twenty five years, Andrea Miller knows full well the personal and emotional effect of this serious illness. Her knowledge has been developed from grass roots experience of having a daughter with CF, a previous Board member of CF New Zealand, a past chairman of the CF New Zealand Research Fund, and life member of the Australian Capital Territory CF Association. In addition, she has a wealth of medical and scientific knowledge and has developed networks related to CF therapeutic development which stem from her internship at the CF Foundation in Bethesda, Maryland, USA in 2010. Her leadership and business skills have been acquired through her previous roles: as a senior officer in the New Zealand Armed Forces (including peacekeeping with the United Nations), a leadership role in the public service, and as a business development manager in a regional economic development authority.

Warning statement

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.

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