The best drug in the world won’t do much if it cannot be delivered to where it needs to be in the body and at proper therapeutic levels, and many drugs can do a great deal of harm because they don’t remain localized to just the diseased cells, tissues and the like. These are challenges that crop up often in areas like cancer treatment, attempts to cross the blood-brain barrier, and gene therapies, but it’s not limited to those areas.
And so, while we generally like to focus on the discovery, development and testing of therapeutics, every once in a while we dip our toes into the waters of the drug delivery process and recent news in that arena, as you will see in the following stories.
An unfolding microneedle injector for biologics
LONDON—A luminal unfolding microneedle injector (LUMI) capsule in development at the Massachusetts Institute of Technology (MIT) in the United States in collaboration with scientists from Novo Nordisk in Sweden aims to orally deliver drugs that would normally need to be injected. If the capsule is proven safe and effective in clinical trials, it could greatly help expand the range of treatment options available to patients receiving biologic therapies, says data and analytics company GlobalData.
When treating chronic diseases, it is crucial that the therapies not only be effective, but also easily tolerated and administered by patients, GlobalData notes, adding that although biologic therapies like insulin and TNF-α inhibitors have transformed the standard of care in their respective indications, nearly all biologics require administration via subcutaneous or intravenous injection. These methods of administration are often inconvenient and uncomfortable for patients.
“Oral delivery of biologics has been long complicated by the poor absorption of the larger macromolecules through the intestinal wall,” noted Rose Joachim, senior immunology analyst at GlobalData. “The LUMI capsule aims to address this problem through the use of microneedles that deploy upon reaching the small intestine, carefully penetrating the walls and delivering a drug directly into the bloodstream. As it is being developed in collaboration between scientists from MIT and Novo Nordisk, it is possible the technology will soon be seen in Novo Nordisk’s pipeline or perhaps as the flagship product of a spinout or startup venture.”
As GlobalData points out, there certainly appears to be an unmet need in the market. For example, excluding vaccines and allergenics, it estimates that despite the existence of hundreds of biologic therapies available on the U.S. market and in late-stage clinical development, there are only six marketed and 14 Phase 3 or later orally administered biologic or synthetic peptide therapies across the U.S. pharmaceutical market.
“Interestingly, a similar therapy is in development by a small biotech company called Rani Therapeutics. The RaniPill is a capsule containing machinery that can also inject a drug of interest directly into the intestinal wall. In late 2017, Rani and Shire entered into a collaboration to evaluate the use of the RaniPill in the oral delivery of Factor VII,” said Joachim. “This vote of confidence from Big Pharma, along with the announcement of a successful first-in-human study in February 2019, may put the RaniPill ahead of the MIT/Novo Nordisk team’s LUMI capsule. The growing competition between these two groups will certainly be one to watch over the coming years.”
Delivery system can enhance RNA vaccines
CAMBRIDGE, Mass.—In other news related to MIT, the university touted in late September a breakthrough related to packaging vaccines in novel nanoparticles as a new way to fight cancer and infectious diseases. MIT chemical engineers developed a new series of lipid nanoparticles to deliver vaccines, and showed that the particles trigger efficient production of the protein encoded by the RNA while also behaving like an adjuvant to further boost the vaccine effectiveness. In a study of mice, they used this RNA vaccine to successfully inhibit the growth of melanoma tumors.
“One of the key discoveries of this paper is that you can build RNA delivery lipids that can also activate the immune system in important ways,” stated Daniel Anderson, an associate professor in MIT’s Department of Chemical Engineering and a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science.
Clinical trial explores intranasal epinephrine spray
RALEIGH, N.C.—In October, Bryn Pharma noted that it has developed an epinephrine nasal spray, a disruptive innovation designed to replace the currently approved epinephrine auto-injector. Over the last three years, Bryn has conducted extensive preclinical and clinical trials of its intranasal epinephrine spray (BRYN-NDS1C), which is said to be easy-to-use, needle-free and completely portable. Bryn’s novel intranasal drug delivery device has already been approved for use in other indications by the U.S. Food and Drug Administration (FDA).
In early 2019, the company submitted an IND application for BRYN-NDS1C with the FDA and was granted Fast Track Designation. Bryn has successfully completed the required pilot studies and has completed dosing in its pivotal clinical trial.
“We are pleased to report that Bryn’s clinical development program for BRYN-NDS1C has met all milestones to-date,” said Dr. David Dworaczyk, CEO of Bryn Pharma. “The product demonstrated comparable pharmacokinetics to an intramuscular injection of epinephrine [in our studies]. We are looking forward to the results of our pivotal trial shortly.”
Integrating glucose sensing and insulin delivery
BRIDGEWATER, N.J. & ABBOTT PARK, Ill.—Sanofi and Abbott are partnering to integrate glucose sensing and insulin delivery technologies that together would help to further simplify how people with diabetes manage their condition. The two companies aim to develop tools that combine FreeStyle Libre technology with insulin dosing information for future smart pens, insulin titration apps and cloud software.
“For close to a century, Sanofi has been supporting those living with diabetes through our robust portfolio of medicines. This strategic relationship with Abbott is representative of the next evolution of our commitment for better diabetes care by incorporating digital tools into the daily life of people living with diabetes,” noted Gustavo Pesquin, senior vice president of the global diabetes and cardiovascular franchise at Sanofi. “By partnering with Abbott, we are a step closer to realizing our connected ecosystem, which would help improve control and the quality of life decision cycle for patients through individualized glycemic management of diabetes.”
The non-exclusive collaboration will initially enable data sharing—at the consent of the user—between Abbott’s FreeStyle Libre mobile app and cloud software and Sanofi’s connected insulin pens, apps and cloud software that are currently in development. This data sharing will enable both people with diabetes and their doctors to make better-informed treatment decisions around medication, nutrition and lifestyle.
“As the global leader in continuous glucose monitoring, we see a significant opportunity to impact the health of millions of people living with diabetes by developing new tools and connectivity with Sanofi, a leader in the insulin space,” commented Jared Watkin, senior vice president of the Diabetes Care division at Abbott. “Diabetes can be overwhelming, as it is an information-rich condition with various streams of data from multiple devices. Building a digital ecosystem around FreeStyle Libre simplifies the user experience by consolidating how people get their data—both through offering Abbott’s digital health tools and by working with other diabetes and technology leaders.”
Transdermal delivery of cannabidiol
GUILDFORD, U.K.—Futura Medical plc, a pharmaceutical company developing a portfolio of products based on its proprietary, transdermal DermaSys drug delivery technology and currently focused on sexual health and pain, recently announced a joint venture collaboration with CBDerma Technology Ltd. to explore the application of DermaSys for delivery of cannabidiol. All intellectual property will be owned jointly by the company and CBDerma.
“Futura’s core strength lies in our research and development capabilities, particularly in the application of our proprietary Dermasys transdermal delivery system, which enables targeted and controlled delivery of drugs through the skin,” said James Barder, CEO of Futura Medical. “The benefits and applications of cannabis and cannabidiol in both the medical and consumer markets are well known and expanding rapidly. However, optimized and targeted topical delivery of the active ingredients remains a problem. We believe that our Dermasys technology has the potential to solve these issues, advancing product development and expanding indications and use of cannabidiol.”