Cardiovascular diseases (CVDs) stand as the leading cause of global mortality, surpassing the combined impact of all cancers. Despite significant strides in reducing cardiovascular mortality since the mid-20th century, especially in the developed world, the burden of heart failure (HF) has surged in recent decades. In this blog post, we embark on a journey through the complexities of cardiovascular drug development, shedding light on the challenges, breakthroughs, and innovative approaches that make it a grand challenge for our generation.
Prevailing Unmet Need & Mixed Success
The decline in ischemic heart disease mortality has been a notable achievement, credited to advancements like β-hydroxy β-methylglutaryl-CoA reductase inhibitors and P2Y12 ADP receptor antagonists. However, the adoption of Western lifestyles in the developing world has led to a resurgence in CVD prevalence, signaling a global health concern. HF, in particular, has emerged as a formidable adversary, affecting millions worldwide with high mortality rates, often surpassing even certain cancers. While medical and surgical therapies have transformed the landscape of cardiovascular care, HF remains a persistent challenge. Despite significant progress in goal-directed medical therapy and internal cardiac defibrillators, HF continues to be a progressive disease, necessitating advanced interventions like heart transplantation. The 1-year mortality for those without such interventions remains alarmingly high, marking HF as one of the largest unmet medical needs of the 21st century.
The Dilemma of Drug Development & Heterogeneity
Drug companies grapple with exorbitant costs in developing new molecular entities (NMEs), often exceeding $3 billion per launched NME. The high stakes stem from the fact that only a small fraction of candidate NMEs eventually gain approval. The blog post explores the declining trends in cardiovascular drug development, emphasizing the need for new, efficient paradigms to address the dual societal demands for effective therapies and lower drug costs. Human genetics emerges as a powerful tool in cardiovascular drug development. The success stories of SGLT2 inhibitors and tafamidis underscore the potential of understanding genetic factors in CVDs. It is crucial to leverage genomics to enhance target selection, reduce development risks, and accelerate the discovery of novel therapeutic strategies. HF's heterogeneity poses a significant challenge, urging a shift from broad categorizations to more mechanism-based subclassifications. We desperately need a comprehensive understanding of HF etiology, stressing the importance of earlier vetting of drug candidates in the development process.
Challenges and Opportunities in CVDs
Several challenges in CVD drug development including disease heterogeneity and positive reporting bias emphasize the need for rigorous studies and encourages the publication of "negative studies." There is a lot of potential in using electronic health records and real-world data to discover new therapeutic targets and repurpose existing drugs for cardiovascular morbidities. To enhance success in cardiovascular drug development, key opinion leaders propose a collaborative ecosystem involving academia, small biotech, and large biopharma. The emphasis is on fostering deep mechanistic research, early-stage risk-taking, and talent development to propel innovation and address the urgent need for transformative therapies.
CVD Landscape & Emerging Trends
CVDs remain one of the largest areas of drug development today, as highlighted by the active development pipeline below, with over 1300 assets in early discovery and preclinical stages and more than 500 assets in clinical development. As expected, out of those active programs, traditional molecule types as small molecules and proteins make up >50% of all CVD assets in development. The Landscape analysis also reveals the most commonly targeted pathways and proteins, including coagulation factors, calcium regulators, guanylate cyclases, prostaglandin receptors, apolipoproteins, PCSK9, and others. Furthermore, investing activities remained high regarding total deal counts in the last years, with 230+ yearly deals since 2018. Obviously, most deals were VC financing deals, followed by M&A and PE. Regarding total capital raised, 2023 was characterized as a bounce back year in CVD investments, mainly driven by an increase in strategic M&A deals increasing from $2.10bn in 2022 to $9.33bn in 2023.
Most VC Capital Raised in CVD Space in 2023
HeartFlow ($828.78mn; developer of a cardiac diagnostic platform designed to transform the diagnosis and management of coronary artery diseases)
ADARx Pharmaceuticals ($352.5mn; offers a proprietary ribonucleic acid targeting platform, including oligonucleotides for inhibition, degradation, and editing, together with novel oligonucleotide delivery technologies)
Cardurion Pharma ($343.15mn; targeting several pathways, including two clinical programs with a PDE9 inhibitor in Phase II and a CAMKII inhibitor in Phase I)
DalCor Pharmaceuticals ($302.44mn; develops dalcetrapib in Phase III, the first pharmacogenetic precision medicine in cardiovascular disease that specifically targets patients with the AA genotype in the ADCY9 gene)
Top CVD Investors in 2023
Webster Equity Partners (8 deals)
OrbiMed (5 deals)
HBM Healthcare Investments (3 deals)
Reach Out for More!
The landscape analysis of emerging trends contains a comprehensive list of companies/assets to watch, investors most actively involved in the CVD space, and more. Reach out for more!
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At NicinBio Strategy, our mission is clear: to be a vanguard of impactful strategic insights in the biopharma industry. With a focus on competitive intelligence, asset search, and due diligence, we aim to empower our clients to not just navigate the complexities of the biotech landscape but to thrive in it. Join us on this transformative journey as we redefine the possibilities and potentials within the biopharma sector, one strategic insight at a time. Together, let's chart a course toward a future where innovation and strategy converge for unprecedented success.
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