Inflammasome Therapeutics, a company specializing in the development of sustained-release drug delivery systems and therapies for degenerative diseases, has announced receipt of a $1.3m USD grant to support the development of its 12-month implant designed to prevent HIV infection in women as well as pregnancy. The funding marks the company’s second infusion of funding from the Bill and Melinda Gates Foundation.
According to March 2021 Kaiser Family Foundation report, women represent more than half (55%) of all adults aged 15-49) living with HIV worldwide, with HIV (coupled with complications related to pregnancy) is the leading cause of death among women of reproductive age. What’s more, the report states, women and girls account for 58% of the estimated 240,000 new HIV infections in Western and Central Africa, where the virus runs rampant.
Paul Ashton, Inflammasome Therapeutics CEO, spoke to Outsourcing-Pharma about the development of the combination implant, and what it could mean for people in regions hard hit by HIV.
OSP: Could you please tell us about Inflammasome—who you are, what you do, key capabilities, and what sets you apart from other companies in this sphere?
PA: Inflammasome Therapeutics is a privately held company developing products to treat chronic diseases including multiple sclerosis (and oral product) and macular degeneration (an implantable drug delivery device). We expect these products to enter clinical trials next year. We have a uniquely experienced development team that has developed four of the five US Food and Drug Administration (FDA) FDA-approved sustained-release products for retinal disease; because of this experience, in 2019 we entered into a $160m USD collaboration agreement with Boehringer Ingelheim to develop ocular products.
The technologies we have developed allow for long-term, constant delivery of small molecules for years after injection. Because of the size limitations (they have to be small enough to fit into an eye), the implants are very space-efficient. Please tell us a little bit about the path that led Inflammasome to come up with this islatravir/levonorgestrel implant.
A logical extension of this work led us to begin the development of a long-term levonorgestrel implant (funded by the Bill and Melinda Gates Foundation). Currently available implants are quite cumbersome to insert, they are large and have to be removed when they start to become depleted.
Our technology offers the possibility of making bio-erodible implants that are easier to administer and don’t have to be removed. What could be better? Perhaps an implant that also provided protection against HIV infection. We are using similar technology to develop implants releasing both LNG and islatravir. Again this is being funded by BMGF.
OSP: Could you tell us about the reasons why it makes sense to combine these two different treatments in a single device?
PA: In many developing nations two big risks in women’s health are unwanted pregnancy and HIV infection. A single implant protecting against these would be a huge win
OSP: Why is the biodegradable implant format a suitable delivery method for this combo?
PA: One of the potential issues for a birth control implant is that it should stop releasing after a known period of time (so the patient can use the implant to help her decide when to have children). With current systems, drug release gradually slows down and after some years becomes progressively less reliable. Better to know in advance when birth control will wear off, so as to get another one or be able to have a child.
Another issue for current implants is that they can be difficult to remove, and if they break during removal it can be a problem; bio-erodible implants take care of both issues. Similar arguments apply to islatravir for the prevention of HIV. It needs to be present at a therapeutic concentration and ideally not to have a long period of sub-therapeutic drug levels (with the possibility of resistance etc).
OSP: How did you come to work with the Gates Foundation, and land the initial grant to fund the development of the device?
PA: The BMGF people have a very clear view of what will make a big impact on global health. They were aware of our experience in successfully developing implants, so I think the “fit” of our technology/regulatory expertise and their view of what is clinically required was quite natural.
OSP: Do you have anything to add?
PA: One of the offshoots of this current work would be the development of implants that release islantravir only. These could be useful for the prevention of HIV infection more generally.
The technology has many other possible applications, certainly more than we can manage ourselves. That’s one of the reasons we are happy to work collaborate with other entities.
