Today, we’re thrilled to sit down with Faisal Zain, a renowned expert in healthcare and medical technology. With a deep background in the development and manufacturing of cutting-edge medical devices for diagnostics and treatment, Faisal has been at the forefront of innovation in the field. In this interview, we dive into the exciting work of a biotech startup focused on severe lung diseases, exploring their unique approach to drug development, the science behind their lead candidate, and the potential impact on patients with debilitating conditions like pulmonary arterial hypertension. We also touch on the challenges of clinical trials, strategic partnerships, and the future of therapies in this critical area of medicine.
Can you tell us about the mission behind this biotech startup and what sets its approach apart in the crowded field of drug development?
Absolutely. Our mission is to tackle some of the most challenging cardiopulmonary and fibrotic diseases with innovative therapies that go beyond conventional treatments. What makes us unique is our focus on adapting validated science from other areas—like treatments for eye conditions—and applying it to lung diseases. We’re building on a foundation of proven mechanisms, specifically targeting enzymes called Rho kinases, to address unmet needs in conditions like pulmonary arterial hypertension. Our goal is to deliver first-in-class solutions that can transform patient outcomes.
What personal or professional experiences inspired you to take on this ambitious project in the lung disease space?
My journey in healthcare and medical technology has always been driven by a passion for solving complex problems that impact lives. I’ve spent years working on medical devices that aid in diagnostics and treatment, and that gave me insight into the gaps in therapeutic options for severe diseases. When the opportunity arose to work on a novel drug candidate with potential in lung diseases, it felt like a natural fit. My past experiences in navigating innovation from concept to market also gave me the confidence to build a team and strategy that could push this science forward.
Let’s dive into your lead drug candidate. Can you explain in simple terms what it does and why targeting specific enzymes is so important for lung conditions?
Sure. Our lead candidate is a small molecule designed to inhibit two enzymes known as Rho kinases, or ROCKs. These enzymes play a big role in how cells function, especially in blood vessels. When they’re overactive, they can cause issues like narrowing of arteries, inflammation, and scarring. In lung diseases like pulmonary arterial hypertension, or PAH, this leads to dangerously high blood pressure in the lungs. By blocking these enzymes, our drug not only helps widen the blood vessels to ease pressure but also tackles the underlying problems like cell overgrowth and tissue scarring. It’s a multi-pronged approach that could address root causes, not just symptoms.
How did the opportunity to acquire this drug candidate come about, and what made it the right fit for your vision?
The drug was originally developed by another entity and later became part of a larger pharmaceutical company’s portfolio. However, their focus wasn’t on lung diseases, so the molecule wasn’t a priority for them. We saw a unique opportunity to step in because the preclinical data was incredibly promising, and it aligned perfectly with our goal of addressing cardiopulmonary challenges. Our team had the right expertise to take this drug forward, and licensing it allowed us to hit the ground running with a compound that had a strong scientific foundation.
Can you share more about why pulmonary arterial hypertension, or PAH, is your primary focus, and what specific challenges patients with this condition face?
PAH is a devastating condition where the arteries in the lungs become narrowed and thickened, making it hard for the heart to pump blood through them. Patients often deal with severe shortness of breath, fatigue, and a significantly reduced quality of life. Many current treatments focus only on relaxing the blood vessels, but they don’t fully address the disease’s progression, like the buildup of scar tissue or abnormal cell growth. That’s why we’re targeting PAH—it’s an area where there’s still a huge need for therapies that can slow or even reverse some of these damaging processes, and we believe our drug has the potential to make a real difference.
Your drug also seems to target multiple aspects of PAH beyond just easing blood vessel constriction. Can you elaborate on how this broader impact could change the treatment landscape?
Absolutely. While many existing PAH drugs focus on vasodilation—basically, widening the blood vessels to lower pressure—our approach goes further. By inhibiting Rho kinases, we’re also addressing the excessive growth of cells in the artery walls, the inflammation, and the fibrosis, or scarring, that contributes to the disease. This multi-action mechanism could mean not just managing symptoms but potentially altering the course of the disease. If we can reduce the structural damage in the lungs, we might offer patients longer-term benefits and a better chance at stability, which would be a significant step forward.
You’re also exploring pulmonary hypertension with interstitial lung disease, or PH-ILD. How does this condition differ from PAH, and what role does your drug play in treating it?
PH-ILD is a bit different from PAH because it arises from underlying interstitial lung disease, which is a progressive scarring of lung tissue. This scarring leads to high blood pressure in the lungs, similar to PAH, but the root cause and disease progression are tied to this broader lung damage. Current treatments for PH-ILD are limited, often relying on inhaled drugs to manage symptoms. Our drug, being an oral therapy, offers a different approach by targeting the same enzyme pathways to reduce vascular pressure and potentially impact the fibrotic processes. We see it as a complementary option that could fill a gap for these patients.
Can you give us a glimpse into the early clinical trial results for your drug, particularly around its safety profile?
I’m glad to share what I can. We’ve completed a Phase 1 trial in healthy volunteers, and while full details will be presented at an upcoming scientific congress, I can say that the drug was found to be safe and well-tolerated across the participants. One major concern with inhibiting both ROCK enzymes was the risk of low blood pressure, which could be dangerous. Thankfully, we saw no evidence of that in our study, which is a really encouraging sign as we move into the next stages of development.
Speaking of next steps, how are you planning the upcoming Phase 2 trial to evaluate your drug alongside existing treatments?
Our Phase 2 trial is designed to look at how our drug performs in real-world scenarios for PAH and PH-ILD patients. We’re setting up the study with different arms—one combining our drug with standard therapies, and another testing it alongside newer treatments that target different pathways. The idea is to see how it complements what’s already out there, rather than replacing it. We’re focusing on patients who still have high lung pressures despite current treatments, to really understand if our drug can provide additional benefits. It’s a 24-week study, and we’re excited to see how it unfolds.
Looking ahead, what is your forecast for the future of therapies in cardiopulmonary and fibrotic diseases?
I’m optimistic about where we’re headed. The field is evolving rapidly, with more focus on understanding the complex biology behind these diseases. I think we’ll see a shift toward combination therapies that target multiple aspects of conditions like PAH and PH-ILD—think drugs that work together to address both symptoms and disease progression. Advances in personalized medicine will also play a big role, helping us tailor treatments to individual patients. Our hope is to be part of this wave, bringing innovative options that can truly improve lives over the next decade.
