Macro Trials – a new precision research clinical platform – recently launched to transform clinical trials. And the company’s founders incubated Macro Trials with INITIATE Studios, a venture studio that co-creates companies at the intersection of healthcare, life sciences, and technology.
As part of the launch, the company also announced $6 million in seed funding for ongoing product development, expanding its clinical trial infrastructure across geographies and therapeutic areas, and scaling its study execution and data generation flywheel as it fills an urgent market need. And the funding round was led by MBX Capital and included participation from INITIATE Ventures, Healthy VC, Inflect Health, and Village Global.
In 2021, there were a record-breaking 84 new drugs launched and another 20,000 in development. Even though $212 billion was spent on R&D, success rates reached a record low of 5%. These high failure rates continue to drive up the expense associated with bringing a new drug to market: it now costs approximately $2.7 billion to commercialize a high-value therapeutic with 70% of that spend attributed to conducting clinical trials.
But 80% of those trials fail to meet enrollment goals and the challenges don’t end there. And even after a drug has been approved by the FDA, that drug may still fail to achieve its therapeutic target in the broader population, often due to significant under-representation of people of color, women, and older adults in the clinical trials that were conducted. And Macro tackles these issues head-on to bring rigorously tested, life-saving drugs to market faster and cheaper than ever before.
Through its digitally powered infrastructure, Macro works closely with pharmaceutical companies, CROs, physicians, and health systems to design, plan, and execute clinical trials for high-value therapeutics with increased research velocity. And through the aggregation and synthesis of proprietary real-world evidence (RWE), Macro generates an immensely valuable longitudinal patient record.
Powered by a distributed “hub-and-spoke” model, the company has conducted trials in all research settings – from in-person to decentralized. And Macro’s turnkey platform empowers physician groups and independent clinicians to participate in groundbreaking research via workflow-native efficiency tools, clinical research personnel, a network of logistic partners, and digital infrastructure for real-time data collection and management. And by enabling patient recruitment at the site of care, Macro and its network of principal investigators lower the barrier to entry in clinical research by meeting patients where they are, driving a track record of equitable enrollment that reflects the diversity of the impacted population.
From even the earliest trials, Macro has proven that it truly unlocks increased diversity for results that map to real-world patient demographics for greater post-market success. For example, based on a recent representative study Macro enrolled more than 75% female trial participants compared to an industry standard of 41%; showed age disparity between trial participants and patients of less than one year, compared to the typical 7-10 years; and 46% of Macro’s trial participants were Hispanic-identifying compared to the typical 6% average Hispanic representation observed in clinical research.
“High-value therapeutics are the largest and fastest growing segment of pharmaceutical pipelines, but because clinical trials are fundamentally broken, many life-saving drugs will never make it to market. And those that do will cost far more than they should. Macro’s patient centric model and generation of net-new data will improve the R&D landscape so that safer, better drugs will become more accessible.”
— Zeshan Muhammedi, Managing Partner of MBX Capital
“We are living through a golden age of therapeutics, but there are glaring gaps that make it challenging for breakthrough research to be brought to market. Macro Trials is purpose-built to address these gaps with our patient-focused, end-to-end clinical research platform. Harnessing the latest technology advances, we believe we can amplify therapeutic value from one patient to millions, ultimately transforming care.”
— Iana Dimkova, CEO of Macro Trials