Make It So
The extended release oral dosage form developed by Gio Traverso and colleagues has the potential to vastly improve drug delivery and compliance; but how easy will it be to bring to market?
Lyndra, Inc. (Watertown, MA, USA) was formed to commercialise the gastro-resident system; here we catch up with Ray Knox (Senior Vice-President of Manufacturing) and Ellie McGuire (Head of Business Development) to hear about the company's recent progress.
How did you get involved with Lyndra?
Ray Knox: A couple of years ago, when I was working for a contract manufacturing organization, I started talking with Andrew Bellinger (one of the Lyndra co-founders) about manufacturing such a novel dosage form. With 28 years’ experience in the medical device, biotech and biopharma industry, we felt I could contribute to this endeavor and I now head up Lyndra's manufacturing activities.
Ellie McGuire: I have worked with start-up biotechs for most of my career and have had the pleasure of working closely with Bob Langer and Amy Schulman (Lyndra CEO) over the past four years. I was involved with the commercial plans for this technology even before Lyndra was founded.
What stage are you at with this innovation?
RK: We are starting human trials this fall. We’ve done extensive testing of our dosage form in both porcine and canine models – well over 300 animals in total. We can’t release the animal data yet, but we anticipate using the information to support our first-in-human trial towards the end of this year. For our lead candidate we will be pursuing a 505(B)(2) pathway.
What challenges has Lyndra faced?
EM: The main challenge faced by the inventors of this technology – Traverso, Langer and Bellinger – was to achieve gastric residence and thereby permit ultra-sustained drug release. For a number of years, large companies have tried to solve the medication compliance issue by increased gastric residence -- we have solved that problem in a new way, which was both our major challenge and our major achievement.
RK: That broad challenge was comprised of many smaller hurdles, like ensuring appropriate release kinetics over the duration of gastric residence. It required careful preformulation and formulation work to develop a blend of materials that will give us both the flexibility and tunability to achieve the desired target product profile for a range of compounds. I’d say we have successfully overcome these technical hurdles. It’s always challenging to control sustained drug release in a variable environment like the stomach, but we are making progress. . As this dosage form is novel, its manufacturing is a major area of focus for us; however, we do not anticipate any major manufacturing obstacles going forward. Furthermore, we’ve built up a broad array of intellectual property to support not only the design of the dosage form, but also how the design is produced.
Have you discussed your approach with regulators?
RK: Yes, the regulators love to get discussions going at an early stage! Certainly these conversations are ongoing, and they have been very positive, but we are still early in the process. Nevertheless, I can say that these preliminary discussions have not identified anything that would be a significant challenge from a clinical trial or drug approval perspective.
What commercialization strategy do you anticipate?
EM: We have a dual track business model. We are developing internal product candidates, and at the same time we are working with strategic external partners to co-develop ultra-long acting sustained release formulations of their proprietary compounds. In addition, we are collaborating with several institutions, and we hope these efforts will lead to globally accessible products suitable for resource-poor countries.
How do you feel about being involved in this project?
EM: It's inspirational! We have the opportunity to make a real difference in terms of medication adherence, which is a big issue in all markets – approximately 50 percent of patients do not adhere to their medication regimens, and that leads to negative health outcomes. The aspect that I have enjoyed most in the process of building Lyndra has been assembling an absolutely spectacular team of scientists, engineers and business personnel. Each individual has their own reason to be inspired by the technology – one of our scientists worked for the Peace Corps, for example. We’ve created an environment where we can all collaborate and innovate to push forward this unique technology.
RK: Ellie covers it perfectly. Watching the team grow has been wonderful- in particular, from a cultural perspective it is a pleasure to work in a majority female company. In a few years, I believe we will have developed into a leading pharmaceutical company with ultra long-lasting oral dosage forms that radically change the way patients are treated.
