The makers of a promising drug against laminitis say they are hoping to get the product to market in six months.
Willowcroft Pharm Inc. is seeking Food and Drug Administration (FDA) approval for Laminil, an injectable drug treatment for acute and active chronic laminitis that inhibits the inflammatory response and the laminitis cascade.
It has proven effective in treating both acute laminitis and active chronic laminitis.
The active ingredient of Laminil is already approved for use in humans by the FDA, and has been approved for investigational drug testing in horses.
It is being tested in top veterinary facilities such as the Dubai Equine Hospital and the Rood & Riddle Equine Hospital in Kentucky.
Laminil’s developer, Charlie Owen, told Horsetalk he had received results back on the drug’s use in about 110 horses, involving some 220 hooves.
He said the drug delivered significant improvement in 80 per cent or more of cases.
Laminil has shown effectiveness with all types of laminitis such as insulin resistance, equine metabolic syndrome, grain overload, grass founder, trauma, and weight-bearing laminitis.
“The reaction from owners and veterinarians of those horses was very positive across the board in describing how the horses responded,” Owen said.
Owen said the drug reduced the damaging process of inflammation, thus allowing natural healing to take place.
If given within 72 hours of a case developing, horses were likely show signs of improvement within 72 hours of receiving the drug.
If horses had been affected by the condition for a month, it could take two weeks to show signs of improvement, he said.
Owen said data had already been submitted to the FDA and he was hoping for approval in about six months. It was being progressed through a fast-track program known as “minor use, major species”.
Many vets said they wanted to continue receiving shipments of the drug to treat future cases, Owen said.
“At the same time, we experienced a lot of frustration over not being able to meet demand.
“In the days following our announcement that we needed laminitic horses for clinical testing, we were flooded with calls from owners and vets of laminitic horses around the world and simply couldn’t manage to serve that kind of volume at this stage. In one day, we received 97 calls.
“We also heard some very sad stories of horses being put down because they deteriorated too much in the hours before the shipment of Laminil arrived.
“If the drug had been on the market and on vets’ shelves, perhaps these cases might have had better outcomes.”
That aside, Owen said one of the challenges was a lack of awareness about the drug.
“Many laminitis researchers don’t mention it when talking to the media about current research.
“While we’ve worked hard to raise Laminil’s profile in the last two months, we still feel as if many owners and vets are unaware of Laminil or are being told by researchers that this drug is just a flash in the pan and won’t make it in the long run.
“This is simply not the case.
“Two world-respected equine hospitals are continuing to test the drug on horses because they’re pleased with results and they’ve asked to continue.”
“We’ve wrapped up the rest of our testing because we have enough data. The next step is presenting our results to the FDA.”
The company was approaching investors now to meet the costs of getting the drug through the regulatory process.
Laminitis has several triggers, but the end result is the same: inflammation. This leads to destruction of the delicate laminae that connect the hoof wall to the coffin bone inside the hoof. The disease has ended the life of such great racehorses as Secretariat and Barbaro.
About 3 to 4 percent of the estimated nine million horses in the US will develop a case of laminitis annually. Worldwide, there are hundreds of thousands of cases of laminitis per year.
Laminitis is considered the No. 2 killer of horses, behind colic, and cases can be notoriously difficult to treat.
Laminil is described as a mast cell stabilizer that inhibits inflammatory mediators and other chemicals from being released from the mast cell in excess. When the inflammatory mediators are not released in excess, then the laminitis cascade is broken/halted, and the horse is able to heal and recover.
More information: laminil.us. People can register on the website for updates on the drug.