COMPANY
Breath Therapeutics, a Zambon company, is developing a first-in-class inhaled drug-device therapy for the treatment of bronchiolitis obliterans syndrome (BOS), a rare, orphan respiratory disease with high unmet need and no treatment available.
The BOSTON Phase 3 clinical development program is evaluating a potential new treatment for BOS, a devastating lung disease with very high mortality that commonly affects patients following lung transplantation or allogeneic hematopoietic stem cell transplant (alloHSCT).
Our innovative approach combines a novel formulation of a well-established immunosuppressant drug with targeted inhalation delivery, enabling patients to self-administer the therapy. The rationale of this inhaled therapy is to deliver sufficient concentrations of drug directly to the lungs while minimizing systemic exposure.
Leadership
Our founders and senior management bring together leadership and specialized skills in inhaled drug formulation and manufacturing, pulmonary drug delivery, clinical development, and global commercialization. Our global team works relentlessly to advance the technical and clinical development of inhaled drug candidates and bring them to market.
Dr. Stegemann is the Chief Executive Officer of Breath Therapeutics, a Zambon company. He led the spin off and financing of Breath Therapeutics, and in 2019 the company was acquired by Zambon S.p.A. Dr. Stegemann also serves as a member of the Executive Management Committee of Zambon S.p.A. He brings 20 years of executive management experience in marketing, sales, business and corporate development in small biopharmaceutical companies specializing in respiratory and infectious diseases.
Ms. Burger has over 15 years expertise in senior finance functions for biotech and Medtech companies throughout Europe and has served as lead advisor in numerous transactions, financings and structuring projects. Ms. Burger’s expertise and deep industry experience was instrumental in the financing of Breath Therapeutics and sale of the company to Zambon S.p.A. in 2019.
Dr. Denk is the Chief Operating Office of Breath Therapeutics, a Zambon company. He has over 15 years of industry expertise in pharmaceutical operations and regulatory affairs.
Mr. Shadday is Chief Commercial Officer – USA for Breath Therapeutics and Zambon. Mr. Shadday has more than 20 years of global commercial expertise in strategic and operational marketing and sales functions with leadership roles in US, Europe, Latin America and Asia Pacific.
Collaboration Partners
BOSTON
Our clinical stage BOSTON program is advancing an investigational therapy for the treatment of bronchiolitis obliterans syndrome, a rare and devastating lung disease with no approved treatments available. (1)
Bronchiolitis Obliterans Syndrome (BOS)
Bronchiolitis obliterans syndrome (BOS) is an inflammatory and fibrotic process that affects the small airways, ultimately leading to occlusion. BOS is commonly seen in patients following lung transplantation and allogeneic hematopoietic stem cell transplant (alloHSCT), though it is also associated with autoimmune disease and exposure to environmental contaminants. BOS is a rapidly progressive disease that usually leads to respiratory failure and death within two to four years after diagnosis.(2)
This disease is particularly devastating to those who have already undergone complex and costly lung transplants, as nearly 50 percent of that patient population develops BOS within five years after transplantation.(3)
- Verleden GM, et al. J Heart Lung Transplant. 2019; 38(5):493-503.
- Chambers DC, et al. J Heart Lung Transplant. 2018;37(10):1169–1183.
- Weigt, et al. Semin Respir Crit Care Med. 2013;34(3):336–351.
- Data on File, Breath Therapeutics, a Zambon company, 2019.
BOS is devastating to lung transplantation (LTx) and allogeneic hematopoietic stem cell transplantation (alloHSCT) recipients.
- LTx and alloHSCT
- 37,000
annual procedures
- 171,000
people living with
- 30,000
affected by BOS
There are an estimated 30,000 lung transplant and alloHSCT recipients worldwide with BOS.(4)
No approved treatment exists today for the treatment of BOS
Individuals who have a lung transplant are particularly vulnerable to developing BOS. BOS is seen in 30% and 50% of people at three and five years, respectively, following lung transplant.1
- Ruttens D, et al. J Heart Transplant 2016;35(4).
Barker et al., NEJM 2014; 370:1820-8
Liposomal Cyclosporine A for Inhalation (L-CsA-i)
L-CsA-i, a novel proprietary liposomal formulation of the immunosuppressive drug cyclosporine is combined with the optimized Investigational eFlow® Technology nebulizer system (PARI Pharma GmbH).
BOSTON Development Program
L-CsA-i* for the Treatment of Bronchiolitis Obliterans Syndrome (BOS)
*Liposomal Cyclosporine A for Inhalation (L-CsA-i)
**Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
**Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
People with BOS and Family FAQ
BOSTON Clinical Studies
In the BOSTON program, we are currently conducting two global pivotal phase 3 studies to evaluate the efficacy and safety of L-CsA-i for the treatment of BOS in adults following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation. The BOSTON pivotal studies build on existing clinical experience and over 1,100 patient months of exposure with L-CsA-i.
BOSTON-3 is an open-label extension study for eligible participants who complete the BOSTON-1 and BOSTON-2 studies. BOSTON-4 is currently underway and will assess the safety and exploratory efficacy in adults with BOS following allogeneic hematopoietic stem cell transplant (alloHSCT). BOSTON-5 is a planned safety study in pediatric patients with BOS.
L-CsA-i has received orphan drug designation for the treatment of BOS from the US Food and Drug Administration and European Medicines Agency.
Conditioned upon receiving necessary regulatory approvals, we are preparing market access and product launch plans in the U.S., EU and other global markets. Full commercial-scale production is being established for L-CsA-i and the optimized Investigational eFlow® Technology nebulizer system (PARI Pharma GmbH).
Expanded Access or Compassionate Use
At this time, Breath Therapeutics, a Zambon Company, is unable to provide unapproved medicines via expanded access or compassionate use and believes that participating in its ongoing or future clinical trials is the best way to access this medicine that is not yet approved by U.S. Food and Drug Administration. We have considered many factors, including our ability to maintain supply for the ongoing and planned clinical trials, enroll and complete ongoing and upcoming clinical trials, and make reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting. In the event that Breath Therapeutics, a Zambon Company, decides to consider expanded access use for liposomal cyclosporine A for inhalation (L-CsA-i) in the future, we will evaluate and respond to each expanded access request on a case-by-case basis using criteria that ensures such requests are considered in a fair and consistent manner.
If you or a family member are/is interested in gaining access to our investigational therapy, we encourage you to consult with your physician regarding the possibility of participating in our clinical trial. For additional information about this posted policy or if you are a treating physician requesting expanded access, please contact us via email at Breath.Patients@ZambonGroup.com. We anticipate acknowledging receipt of such inquiries sent to this email within three business days.
The posting of this policy by Breath Therapeutics, a Zambon Company, shall not serve as a guarantee of access to any specific investigational drug by any individual patient. In accordance with the 21st Century Cures Act, Breath Therapeutics, a Zambon Company, may revise this expanded access policy at any time. The policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.
Impact
Our IMPACT program seeks to translate new evidence in the pathophysiology of pulmonary hypertension into a breakthrough disease-modifying drug therapy.(4,5)
Pulmonary Hypertension (PH)
PH is a rare disorder of the pulmonary vasculature with fatal outcome. Despite numerous approved drug products that provide symptomatic relief and delay disease progression, the mortality in PH remains unacceptably high.(6)
IMPACT Drug Candidate
We have identified a very promising drug candidate for the treatment of certain forms of PH. Breath Therapeutics has the skills to combine the promising drug candidate with a proprietary formulation and highly customized nebulizer device to bring a new approach to the treatment of PH.
IMPACT Studies
IMPACT is an early-stage development program for the treatment of pulmonary vascular disease. We will bring our expertise in formulation, aerosol delivery and clinical development together to design a first-in-class therapy.
- Emerging therapeutics in pulmonary hypertension. MK Hensley, et al. Am J Physiol Lung Cell Mol Physiol (2018); 314: L769–L781, 2018. First published February 1, 2018; doi:10.1152/ajplung.00259.2017.
- Translational advances in the field of pulmonary hypertension. SS Pullamsetti, et al. Am J Respir Crit Care Med (2017); 195(4), 425-437
- An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Benza RL, et al. Chest (2012); 448-456
Pulmonary Hypertension (PH) Prevalence Cases in US, EU5, Japan by PH-Subtype
- 72,510
pulmonary arterial hypertension (PAH) – WHO class 1
- 48,900
chronic thromboembolic pulmonary hypertension (CTEPH) – WHO class 4
- 78,720
due to lung disease and/or hypoxia – WHO class 3
- 106,610
due to left heart disease – WHO class 2
- 48,090
due to miscellaneous causes – WHO class 5
According to pulmonary hypertension industry reports.
PLATFORM
Our drug device platform consists of a liposomal drug-aerosol formulation and innovative inhalation technology.
The basis for successful inhalation therapy is drug delivery directly into the small airways of the lungs. This requires a uniquely designed drug formulation paired with an optimized nebulizer.
Liposomes as Drug Delivery System
For our BOSTON program, we use proprietary, lyophilized, unilamellar liposomes as carrier for controlled drug delivery. Liposomes are excellent drug delivery systems to carry insoluble molecules like cyclosporine A to the site of the disease.
Nebulizer Device
Successful aerosol drug-device combinations also depend on optimum device characteristics and performance. For our BOSTON program, we utilize the Investigational eFlow® Technology nebulizer system (PARI Pharma GmbH) specifically optimized for use with our liposomal cyclosporine A formulation.
NEWS
Media
Developing a novel inhaled therapeutic for the treatment of bronchiolitis obliterans syndrome
[Company Sponsored]
In the Press
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Breath Therapeutics2019-08-30 11:34:182019-10-23 13:00:56Zambon acquires Breath Therapeutics for its late-stage lung disease drug
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Breath Therapeutics2019-08-30 11:28:072019-08-30 11:31:10Zambon heading to US market with €500m acquisition
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Breath Therapeutics2019-08-30 11:07:552019-10-23 13:01:14Zambon enters ‘breath-taking’ acquisition deal worth up to $557M; $156M up frontBREATHBLUE
The company is dedicated to protecting our climate and removing CO2 from the atmosphere. To help offset the CO2 emissions we produce as a company, which is mainly related to business air travel, we have partnered with the Blue Planet Certificate. Our BreathBlue initiative supports the reforestation projects of Naturefund, a non-profit environmental protection organization that purchases land to preserve habitats worldwide. Each month, the company plants 40 new trees in a reforestation project in the Andes, Bolivia. To learn more and to become a Blue Planet Certificate partner, please visit blueplanetcertificate.com.
CONTACT
Breath Therapeutics, a Zambon company, operates in Europe from Munich Germany and in the US from Cambridge, MA. In 2019, Breath Therapeutics was acquired by Zambon S.p.A., headquartered in Bresso (Milan), Italy.
USA
One Broadway, 14th Floor
Cambridge, MA 02142 USA
Phone +1 617 294 6608
GERMANY
Aldringenstraße 4 (2nd Floor)
80639 Munich, Germany
Phone +49 (0)89-9042 149 10