Fidelis Pharmaceuticals is seeking partners to leverage and scale up the use of its extended release technology.
The New Jersey, US-headquartered animal health company has developed a non-aqueous mixture comprising several different lipids, which form an injectable suspension. Presenting at the Kansas City Animal Health Corridor 2021 Digital Animal Health Summit, Fidelis claimed its extended release platform technology can enable therapeutic action of drugs for 72 hours or more.
The technology – licensed from John Hopkins University – is covered by three patents and protected until 2038. Fidelis has already used the formulation to develop Ethiqa XR (buprenorphine extended release injectable), which was commercially launched in August 2020. Ethiqa XR is specifically designed for long-acting pain relief in mice and rats.
National Institutes of Health guidelines state when compounds are used for the clinical treatment of animals or to prevent or reduce/eliminate animal pain or distress, pharmaceutical-grade compounds must be used whenever possible. Fidelis claims Ethiqa XR is the first and only pharmaceutical-grade compound available for this use. The product is manufactured under GMP conditions and is available through distributors, such as Covetrus. Ethiqa XR costs $375 per vial, with each containing 60 mouse doses or 20 rat doses.
Michael Wells, chairman and chief executive of Fidelis, said: “The competition in the marketplace [for Ethiqa XR] is a compounded long-acting buprenorphine. It’s been around for years and filled the void until Ethiqa XR was launched. This product can provide 48 hours of pain management and is very affordable at $115 a vial. However, there are several drawbacks to the compounded form. It’s not manufactured under GMP conditions, which means it’s not pharmaceutical grade, meaning there is a high degree of variability from vial to vial. The product is also not sterilized. This is a polymer mixture that is highly viscous and not as easy to administer as our lipid formulation, and acquiring it is not so easy because it is not available through distributors.
“There is another option on the market and that’s a short-acting version of buprenorphine. This is essentially a human drug, which is diluted down by a factor of 10 to get to the appropriate dose in mice and rats. However, that’s a very labor-intensive and mistake-prone process. On top of that, this product has to be administered every four to eight hours to provide appropriate levels of analgesia.”
Now, Fidelis is aiming to secure partnerships to scale up the use of the extended release platform behind its lead product. The firm hopes to use the underlying technology with other pharmaceutical compounds, take it to the companion animal sector and expand its geographic reach outside the US.
Mr Wells stated: “Once [the lipid suspension] is injected into the animal, it forms a fat deposit that very slowly elutes drug substance into the blood stream. We’ve studied this carrier in several different species, including rodents, cats, dogs and non-human primates. Our beachhead in the marketplace is the lab animal market, but we have an eye of expanding and leveraging this technology in the companion animal market as well.”
Fidelis has raised $9 million capital since it was founded in 2016. Initial funding came from management, with Mr Wells personally investing $3m. The firm’s most recent financing was from a series B round in April 2021, where it raised $5m.
Fidelis also has other product candidates already formulated in its pipeline. These are Repriev XR (extended release meloxicam for mice and rats), FP012 (extended release ropivacaine for local analgesia in lab animals) and FP013 (a GMP anesthesia kit for lab animals).
Reprinted with permission of IHS Markit