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December 19, 2016 Issue

CEOCFO MAGAZINE

 

With a Program for their Once Daily Bronchodilator to Improve Airway Function in COPD in Clinical Trials and an Inhaled Antifungal to Treat Fungal Infections in CF and Asthma Patients having Received FDA Orphan Drug Designation - Pulmatrix, Inc. is Delivering on 2016 Goals

 


Dr. Robert Clarke, Ph.D

CEO

 

Pulmatrix, Inc. (NASDAQ: PULM)

www.pulmatrix.com

 

Interview conducted by:

Bud Wayne, Editorial Executive, CEOCFO Magazine, Published – December 19, 2016

 

CEOCFO: Dr. Clarke, last May we had the pleasure of speaking to you about Pulmatrix and your focus on developing therapies for respiratory diseases. Is that still the same today, and if so, why is the focus on respiratory diseases so important?

Dr. Clarke: Hundreds of millions of patients globally suffer from respiratory diseases ranging from major indications like asthma and COPD to deadly rare diseases like cystic fibrosis and idiopathic pulmonary fibrosis. These conditions are debilitating and have major impacts on quality of life and morbidity/mortality. With our technology and expertise, we have the opportunity to improve the lives of these patients. And given the size of the growing global respiratory market, $33B by 2019, there is a significant opportunity to serve patients and build a profitable company.

 

 

CEOCFO: Would you tell us about the different diseases you are focused on, their market sizes today and the potential strain they could put on the healthcare industry and costs should there be no relevant therapies developed and approved by the FDA and various different governing bodies worldwide?

Dr. Clarke: We have two lead programs today, a once daily bronchodilator to improve airway function in COPD and an inhaled antifungal to treat fungal infections in the airways of CF patients and severe asthmatics. We also believe our iSPERSETM inhaled dry powder drug delivery platform will be well served to improve the profile of drugs for IPF, which are currently oral with significant concerns about their systemic side effects. COPD is the fourth leading cause of death globally and growing.  Asthma affects upwards of 100 million patients globally. These are massive patient populations with unmet needs. CF and IPF are considered rare diseases, they respectively affect 75,000 and 200,000 patients globally.  But the burden of care on these patients is tremendous and therefore the unmet need for them is very high. To give a specific example to address the question, our inhaled antifungal therapy for CF fungal infections received FDA Orphan Drug designation this summer. If we are successful, we expect our drug will become first line therapy to treat these infections in these patients. In the absence of this drug, fungal infections can lead to patient hospitalizations and severe outcomes. The cost burden is very high, north of $10,000/day for hospitalized patients. Therefore, having the ability to treat these patients effectively and keep them out of the hospital would result in improvement in quality of life for the patient.

 

 

CEOCFO: You previously mentioned that you were in conversations potential partners. How has that played out over the past 7 months? Are there any developments with new partnerships or existing ones that you can share with our readers?

Dr. Clarke: We continue to talk to partners about our lead programs. As was publicly stated, we recently completed a clinical trail on our PUR0200 COPD bronchodilator as part of collaboration with Mylan. We have an active conversation with them around the program and, as the calendar has advanced, we’re now engaged with multiple potential partners about the EU and//or US rights for the program. We plan to partner PUR0200 for advanced development. We’ve also had early partner interest in PUR1900. As our lead proprietary program, we are open to exploring potential partnerships but we may elect to get further in the clinic with PUR1900 on our own before partnering.

 

 

CEOCFO: Pulmatrix and Mylan reported positive Pharmacokinetic Bioavailability Data for a Pilot Study of PUR0200. Would you tell us about the trial, the disease you are addressing and some of your findings?

Dr. Clarke: The PUR0200 data reported late summer 2016 has helped us advance PUR0200 toward a pivotal trial for Pharmacokinetic Bioequivalence in the European Union via a special Regulatory path that exists only in the EU. The Regulatory guidance states that if we can show a pharmacokinetic match (peak blood levels and blood levels over 24 hours) to a marketed reference product, Spiriva Handihaler, then we can seek approval and marketing rights for PUR0200. We are very pleased with the results of the study that identified two potential paths for achieving PK Bioequivalence. We would like to get back to the clinic with a partner as soon as we can to advance towards the pivotal data set.


 

CEOCFO: What countries offer you the quickest path to approval for your technology and helping the many suffering patient?

Dr. Clarke: We anticipate that we will choose a single reference state, which we have not determined yet, and we seek approval in that country. Once we have approval, we can use our Regulatory dossier to seek approval in any other or all EU countries individually. We certainly look at the larger countries in the EU as obvious reference state targets.


 

CEOCFO: Are there still ongoing R&D efforts on your proprietary iSPERSETM technology itself?

Dr. Clarke: Yes. While we are primarily focused on our lead programs and advancing them to the clinic, we are always working on improvements and expanded strategies for our iSPERSETM technology. We’ve demonstrated over the years the technology is applicable to virtually any drug class from small molecule to protein to even antibody for inhalation. With our internal expertise, we’ve significantly advanced our understanding of iSPERSETM in the context of solid-state chemistry of active pharmaceutical ingredients as well as developed advanced methods to resolve issues associated with compound solubility and molecule chemistry.

 

 

CEOCFO: Why is inhalation such an important delivery approach to treating respiratory diseases?

Dr. Clarke: The lung provides a very interesting portal of entry to more effectively treat respiratory diseases. Pulmatrix today is focused on the local treatment of respiratory disease. By using our expertise and our iSPERSETM technology, we can effectively deliver appropriate doses of drugs to the right site within the lung to treat the condition of interest. In the example of our antifungal program, this illustrates the obvious advantage over current standard of care. Why are we delivering a drug orally to the gut to be absorbed into the blood and subsequently delivered systemically to the lung tissue? You can imagine the low efficiency of this process. And at the same time, the systemic side effects of the antifungal agents are significant. So the obvious improvement is to deliver a more effective dose right to the site of infection by iSPERSETM inhalation while at the same time limiting systemic exposure.

The other aspect of lung delivery is something we consider for the future, systemic delivery. The lung can provide a pharmacokinetic profile that looks almost identical to intravenous injection because of the ability of drugs to cross into the blood at the alveolar membrane, the deepest part of the lung where gas exchange takes place (oxygen in; carbon dioxide out). Couple that with the vast surface area of the alveolar membrane and you have a very effective way to get a rapid peak blood level of a drug. At the same time, one can avoid first pass metabolism in the liver which can enhance drug potency.

 

 

CEOCFO: Have there been any other developments in your other clinical trials since we spoke in May, such as in Cystic Fibrosis?

Dr. Clarke: We are moving rapidly towards the clinical for our Cystic Fibrosis drug and expect to be into patients in mid-2017. This first trial will not only provide us information on safety and tolerability but will also allow us to assess the pharmacokinetics of our inhaled antifungal versus the current oral standard of care. We expect we will see high lung levels and low systemic exposure compared to oral which is the preferred profile one would want to treat pulmonary fungal infection. We’ve generated a significant amount of pre-clinical data over the past year that supports this premise and has shown PUR1900 more effectively treats pulmonary fungal infection compared to the oral control. We intend we will be into a Phase II Cystic Fibrosis Proof-of-Concept trail in 2018.


 

CEOCFO: Are there any conferences you will be attending in the next year and presenting at?

Dr. Clarke: We typically attend the major lung conferences and a few of the disease focused or technology focused meetings. We will be at the American Thoracic Society and plan to be at the European Respiratory Society meeting where we will hopefully present data. In addition, we plan to present data at the North American Cystic Fibrosis Conference in late 2017.


 

CEOCFO: You recently released your Third Quarter results and announced an FDA Orphan Drug Designation for PUR1900. Why is the designation important and what can we look for in fundraising going forward to continue your growth?

Dr. Clarke:  The FDA Orphan Drug Designation is significant recognition of the need in patients and how the FDA believes what we have may better address the challenges the patients face. In terms of fundraising, it is no surprise that an early stage biotech company will need to seek capital to continue to develop our lead programs. However, in the case of what Pulmatrix has, there are potential non-dilutive and partnering considerations for us to make. We have been very good about delivering on our fundamentals and we have to stay that way. The vagaries of the retail markets and the way our stock has been traded over the past year are part of the early stage challenges companies like us often face. We stay positive about what we are doing and we hope investors with a longer term vision will share our passion for delivering for patients in need.

 

 

CEOCFO: With a new administration in place in the United States, have you had the time to reflect on what affect their policies could have on the healthcare industry in general and specifically the goals of Pulmatrix?

Dr. Clarke: President Elect Trump has made it clear that he wants to work with Biotech/Pharma and Government Agencies to build a stronger Healthcare system for US citizens. Working towards a better balance of drug development costs, government requirements for drug safety and efficacy, and a more tenable drug pricing approach will be key. Mr. Trump has spoken about potential tax breaks for companies to keep US companies here as opposed to repatriation and all of that can only bolster the strength of US Drug Development. Mr. Trump has also stated he intends to try and reshape the Affordable Health Care Act which many are very anxious to see in terms of what the changes will be. For Pulmatrix, we have to stay focused on our goals of advancing our development programs and hitting our fundamental targets. Although we certainly think about it and plan for it, we have some time before we have to have our pricing strategies and reimbursement policies fully aligned.

 

 

CEOCFO: In closing, what should we remember most about Pulmatrix as we head into 2017?

Dr. Clarke: As we move into 2017, I hope investors will be looking for Pulmatrix to continue to deliver on the promise of our iSPERSETM technology backed up by additional clinical data. Success is not achieved overnight. In the biotech world, data speaks but patience is required. So I hope we can impress investors with our science and our long term deliverables which will benefit patients and investors alike.


 

“The lung provides a very interesting portal of entry to more effectively treat respiratory diseases. Pulmatrix today is focused on the local treatment of respiratory disease. By using our expertise and our iSPERSETM technology, we can effectively deliver appropriate doses of drugs to the right site within the lung to treat the condition of interest.”- Dr. Robert Clarke, Ph.D


“Hundreds of millions of patients globally suffer from respiratory diseases ranging from major indications like asthma and COPD to deadly rare diseases like cystic fibrosis and idiopathic pulmonary fibrosis. These conditions are debilitating and have major impacts on quality of life and morbidity/mortality. With our technology and expertise, we have the opportunity to improve the lives of these patients.”- Dr. Robert Clarke, Ph.D

 

Pulmatrix, Inc. (NASDAQ: PULM)

www.pulmatrix.com

 

Contact:

Robert Clarke, Ph.D.

(781)-357-2306

rcarke@pulmatrix.com



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