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I'm Aware That I'm Rare: the phaware® podcast

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Sheila Gujrathi, MD and Larry Zisman, MD - phaware® interview 341

Sep 15, 2020

Sheila Gujrathi, MD and Larry Zisman, MD of Gossamer Bio discuss the development of an investigational new treatment for pulmonary arterial hypertension and their Phase 2 Clinical Trial for GB0002.

Learn more about their Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH):

Sheila Gujrathi, MD:
My name is Dr. Sheila Gujrathi. I'm the Co-Founder, CEO, and Chief Medical Officer of Gossamer Bio, which is a clinical-stage biopharmaceutical company located in San Diego, California. I'm a physician by training and I've spent my career dedicated to helping deliver and develop medicines for patients, and I'm so pleased to be talking to you today about our company, as well as our dedication to the field of pulmonary arterial hypertension.

Larry Zisman, MD:
Hello everybody. I'm Dr. Larry's Zisman, I'm a cardiologist by training and I have subspecialty training in pulmonary arterial hypertension. I've taken care of patients with PAH for many years and I'm very excited to be part of Gossamer Bio, where we are developing a new treatment for this disease.

Sheila Gujrathi, MD:
Today, we're here to tell you a little bit more about how Gossamer Bio started and the initial beginnings of our company. First, we'd like to talk a little bit more about our name, Gossamer. We had to take some time to really come up with a name that we felt was very meaningful and reflected what we're trying to do at our startup company. For us at Gossamer, it's not only what we do and why we do things which is always for hopefully the benefit of patients, it's also how do we do things together? So we've named our company Gossamer after the gossamer thread, which is really a metaphor for the invisible connections between two individuals as well as to broader organizations. For those of you who know a little bit about this gossamer thread, you can strengthen this thread and this connection by right actions, right language, by honoring very important values such as trust and transparency. Or you could fray that thread or potentially break it by the reverse and by not honoring our good intentions and actions between each other. And if that connection does get broken, sometime it's irreparable.

It's a constant reminder for us all at the company, not only to honor the relationships we have internally for each other, but also the very important collaboration, connection and network that we have to have with our broader community; the physicians that we work with, the patients who we are trying to honor and treat every single day with our clinical programs, and of course with other companies that we work with when we try to bring new medicines to patients.

Larry Zisman, MD:
As I mentioned, I've taken care of patients with PAH for many years and I've seen what they go through. Although there have been great advances in treatments for pulmonary hypertension, many patients either plateau in their response or continue to get worse. So I felt there was a great unmet need to develop better treatments for this disease. I was fortunate enough to found a company, Pulmokine, many years ago, where we had an idea that we could go after one of the underlying root causes of pulmonary arterial hypertension, which is an abnormal overgrowth of cells within the small blood vessels of the lung. We believed that we could develop a novel approach to attacking this underlying problem by inhibiting a growth factor called PDGF, platelet-derived growth factor. So we developed a novel compound that blocks this pathway. We had evidence from another clinical study that was done quite a few years ago that taking this approach might work. For a number of reasons, that other approach could not be brought forward to patients, but it gave us a clue that if we made a few changes in the approach such as developing an inhaled treatment for this disease maybe we would succeed.

So in those early days, we had a lot of work to do. We were able to actually obtain funding from the NIH, the National Institutes of Health to move this project forward to a point where we could actually begin testing it in people. We were able to do some initial studies in healthy volunteers and we showed that the compound was very well tolerated by inhalation. At that point we realized we would need to partner with a larger company to bring this forward into patients with PAH. Doing clinical studies is a very inexpensive undertaking and so we provided essentially a conceptual framework. We provided the novel molecule that could be formulated for inhalation and we brought it to a point where we could actually start giving this to people. That's really where we needed a lot more investment and we were very fortunate at that point to meet with Sheila, who's just starting her company. Part of it is perseverance, part of it is luck, part of it is just doing good science and being driven by the data and the great need that we all knew the patients had.

Sheila Gujrathi, MD:
When we were first starting Gossamer Bio, we spent some time looking for clinical programs that we thought were very meaningful, that we wanted to bring into the company and support through our world-class talent and clinical development expertise. Through mutual connections, I met Larry Zisman, who was really heading a company called Pulmokine, where he was taking forward this important molecule GB002, into the clinic with grant funding from NIH for PAH patients. As I got to learn more about the program and more about Larry, and what an incredible person and physician he was and how much unmet need there was still in this space, we became very passionate and motivated to see if we could work with Larry. We began to discuss how we could support Larry and the important work he was doing at Pulmokine. We started to understand how important it was for Larry to stay with the program, to be able to actually join our company and shepherd the development of GB002 for patients in need. This was his baby and he was very passionate about making sure we did all the best high quality work to bring this through our clinical trials and hopefully develop a medicine for patients.

Larry Zisman, MD:
One of the underlying problems in pulmonary arterial hypertension is this abnormal overgrowth of cells within the small blood vessels of the lungs. It's as if the drain is getting clogged and the cells overgrow and it's hard for blood to flow through the lungs. That's why patients feel so short of breath because the blood can't get through and it's hard for them to get enough oxygen, and it's hard for them to get blood through to the heart where it can pump to the rest of the body. We need a way to address this underlying problem of abnormal cell overgrowth. As it turns out after many years of research and study and understanding the underlying disease, we landed on going after this platelet-derived growth factor, PDGF. And so we developed a treatment that could block the signaling pathway and thereby help slow down and even reverse this abnormal growth. We have shown that it works in animal models of pulmonary hypertension that represent key features of what happens in humans. We have a very strong preclinical body of evidence from these animal models that targeting this pathway will be effective. We also have evidence even from prior clinical trials that targeting this pathway could work. We now have this drug candidate that can be delivered as a dry powder with a very convenient dried powder inhaler. It's almost like what patients with asthma use. It's a handheld device, it's much simpler than a lot of the other inhalation devices that are currently available for patients. Merging both elements of convenience and targeting this new pathway, we think this holds great promise for a new approach and a new treatment for patients.

Sheila Gujrathi, MD:
GB002 is currently in the clinical development process. We are running two trials, we have a Phase 1B trial that is up and running and enrolling patients with PAH. That trial is continuing to look at safety and tolerability and something we call pharmacokinetics, which really measures the drug levels in the patient's bloodstream. In addition, we are about to start our Phase 2 trial, and we're very excited about this. This will be a longer study where we will test the safety and efficacy for GB0002, for patients who have PAH. So that trial is about to start getting up and running and we're thrilled to be in the clinic.

Larry Zisman, MD:
In all these years that's been building up to this, it's just an effort of faith and love really. I'm just very honored and privileged to be part of it.

Sheila Gujrathi, MD:
As a researcher, when we come upon a program like GB002, it's incredibly exciting for ourselves as a company at Gossamer, all of our employees where we're working every day to make a difference in the lives of patients. The therapeutic promise that we have with GB002 to really make a difference for PAH patients, we think it's very special. We have a saying a Gossamer, "Everyday counts." There is no time to give less than our best, patients are waiting for us. We are really driven to make a difference by doing what is best for patients and really trying to deliver a meaningful therapy. Right now, for us every single day, we are making the investment to do the best clinical trials we can to support Larry and the other individuals who are working as a team on this program. I can't tell you how happy I am that we're actually in the clinic and about the kickoff this Phase 2 clinical trial, and really hoping to again, make a difference for PAH patients. My name is Dr. Sheila Gujrathi...

Larry Zisman, MD:
And my name is Larry Zisman, and I'm aware that I'm rare.

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