Millions of patients around the world depend on medications that require taking a pill daily or even multiple times a day to manage chronic conditions. Poor patient adherence to these oral therapies as well as limited efficacy are a challenge of striking magnitude across disease areas and geographies.
In the United States, approximately 50% of all patients do not adhere to their prescriptions. This, in turn, leads to poor healthcare outcomes and increased rates of hospitalization, costing the US healthcare system over $100 billion in estimated avoidable hospitalization expenses per year(1). The situation in developing countries is even more dire.
In addition to poor adherence, the commonplace “daily pill” has a limited window of efficacy. The human gastrointestinal system digests and excretes ingested substances within 12-24 hours, with only 2-6 hours in the upper GI tract where optimal drug absorption occurs. This process limits the effectiveness of current extended release formulations on the market. To date, no existing oral delivery system has been able to achieve therapeutic serum levels for small molecules beyond 24 hours. Longer periods of sustained serum levels could improve therapeutic efficacy, as well as reduce side effects that result from particularly high or low temporary drug concentrations.
At Lyndra, we aim to fundamentally change the way people take medicines through the development of oral, ultra long-acting, sustained release therapies that drastically improve healthcare outcomes. Recent studies have shown that adherence significantly improves with less frequent dosing, such as weekly or monthly administration(2). In turn, better adherence leads to more favorable health outcomes. For instance, it has been estimated that better adherence to antihypertensive treatment alone could prevent 89,000 premature deaths in the United States annually(3).
Our technology was developed at the Massachusetts Institute of Technology, in the laboratory of Dr. Robert Langer in collaboration with the Bill and Melinda Gates Foundation. Lyndra formulations transform the daily pill into a weekly or monthly dose, promising to improve patient adherence as well as to optimize the pharmacokinetic profile of the dosage form. With weekly or even monthly dosing, the technology promises to redefine what long-acting oral formulation means. Lyndra's innovative oral formulations work via gastric residence. Once inside the stomach, the dosage form, which is encapsulated in a gelatin capsule, adopts a star-shaped configuration. Due to its size and geometry the system remains in the gastric cavity until pre-determined break points permit the formulation to split into small pieces and safely pass through the GI tract similarly to indigestible food. While in the gastric cavity the formulation releases drug at a site of high absorption in the human body. The rate of drug release, as well as the time point of dissolution are highly tunable features. The ultra long-acting, sustained release formulations that Lyndra is developing enable local GI delivery and steady PK profiles that reduce concentration (Cmax and Cmin) driven side effects.
1. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005;353:487-497
2. Kishimoto et al. Arch Osteoporosis, 2015
3. Cutler DM, Long G, Berndt ER, et al. The value of antihypertensive drugs: a perspective on medical innovation. Health Aff (Millwood) 2007;26:97-110