Research by Robert Langer, Giovanni Traverso, Andrew Bellinger and Others Published in Science Translational Medicine
–Novel technology can be applied in fight against malaria and other diseases requiring oral sustained release, long-term drug dosage–
Lyndra, a healthcare company developing ultra long-acting oral drug delivery technologies, announced the publication of a scientific paper describing its novel technology in one of its earliest applications. Lyndra’s revolutionary platform was initially developed at the Massachusetts Institute of Technology in the laboratory of Dr. Robert Langer. Lyndra has begun its own development work on internal and partner candidates. Lyndra’s technology, which redefines ultra-long acting oral therapeutic delivery, has the potential to transform care by improving effectiveness, reducing side effects, and creating substantial savings for patients, the healthcare system, and governments.
Data on the early use of this technology for the treatment of malaria was published today in Science Translational Medicine. The publication entitled “Oral Ultra Long-Acting Drug Delivery: Single Encounter Ivermectin for Malaria Elimination,” describes an ingested capsule that, upon entering the stomach, assumes a geometry that prevents passage through the GI tract, enabling prolonged gastric residence. The Lyndra technology can deliver small molecule therapies for seven days and potentially longer, and, upon the predetermined breakdown of its structure, can safely pass through the gastrointestinal tract. The study demonstrated the long-acting controlled release of ivermectin, a treatment to interrupt the vector transmission of malaria, for up to 14 days.
“This technology promises to rewrite the definition of ultra-long acting oral therapies,” said Dr. Robert Langer, Lyndra co-founder, MIT Institute Professor, and corresponding author on the paper. “Current extended and sustained release technologies achieve therapeutic serum levels for up to 12-24 hours. Lyndra’s technology stands alone by pushing this timeline out to more than a week. The implications for patients are tremendous.”
“People around the world depend on medications that require taking a pill every single day or even multiple times a day,” said Amy Schulman, a co-founder of Lyndra and its CEO. “That approximately 50% of patients in the developed world do not take their medicines as prescribed, a statistic that is even more challenging in the developing world, has a demonstrable effect on healthcare outcomes and a cost estimates to the US healthcare system alone of over $100 billion annually. Lyndra’s long acting technology should make a real dent in this protracted problem and help change the lives of millions of patients who feel tethered to the daily pill.”
Schulman noted that Lyndra’s system offers a number of clinically meaningful benefits including convenient, once weekly (or less frequent) oral dosing, improvements in patient adherence, near constant therapeutic serum levels with more predictable pharmacodynamics, and potential of side effect reductions due to decreased variability of drug concentration. Safety mechanisms to prevent obstruction of food, perforation, mucosal injury and other adverse events are built into the design of Lyndra’s polymer based system.
Lyndra’s next applications extend beyond infectious disease, including chronic diseases such as psychiatric disease, renal disease and addiction. Lyndra will initiate clinical trials for its primary internal product in mid 2017. Lyndra is also partnering with a select number of leading pharmaceutical and biopharmaceutical companies to develop ultra-long acting oral products of their proprietary small molecule therapies. Each product will undergo pre-clinical and clinical testing to satisfy regulatory requirements before being made available to the public.
The study was published today in Science Translational Magazine. Authors include: Andrew Bellinger, MIT, Harvard Medical School, Lyndra; Mousa Jafari, MIT; Tyler Grant, MIT, Lyndra; Shiyi Zhang, MIT; Hannah Slater, Imperial College London; Edward Wenger, Institute for Disease Modeling; Stacy Mo, MIT; Young-Ah Lucy Lee, MIT; Hormoz Mazdiyasni, MIT; Lawrence Kogan, MIT; Ross Barman, MIT; Cody Cleveland, MIT and Harvard Medical School; Lucas Booth MIT; Taylor Bensel, MIT; Daniel Minahan, MIT; Haley Hurowitz, MIT; Tammy Tai, MIT; Johanna Daily, Einstein Medical College; Boris Nikolic, Biomatics Capital; Lowell Wood and Philip Eckhoff, Institute for Disease Modeling; Robert Langer, MIT; Giovanni Traverso, MIT and Harvard Medical School.
Lyndra aims to fundamentally change the way patients take medicines through the development of oral, ultra-long-acting, sustained release oral therapies that drastically improve healthcare outcomes. The Lyndra 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 medications taken daily or more frequently into a weekly or monthly dose, promising to improve patient adherence as well as to optimize the pharmacokinetic profile of the dosage form.