BIO2016: DiaMedica Looks to Woo Potential Partners, Investors for Ischemic Stroke Drug at Conference
June 9, 2016
By Alex Keown, BioSpace.com Breaking News Staff
Like hundreds of other pharmaceutical industry executives, Rick Pauls, chief executive officer of Minnesota-based DiaMedica is descending on the BIO conference in San Francisco this week to network with potential investors about the company’s experimental recombinant treatment for ischemic strokes.
An ischemic stroke occurs as a result of an obstruction within a blood vessel supplying blood to the brain and accounts for about 87 percent of all strokes, according to the American Stroke Association.
For years, DiaMedica has been working on the how to synthesize a Chinese treatment for ischemic stroke victims that is expected to increase the window of treatment time to up to 48 hours. The current Chinese treatment, Kailikang developed by Techpool, is a urine extracted-form of the killikrein protein. There are currently about 40,000 patients who have used Kailikang, which Pauls said provided his company with a lot of data to determine its efficacy and mechanism.
In an exclusive interview with BioSpace , Pauls said the Chinese drug, which has been approved for use in that country, expands the window of time to treat acute ischemic stroke victims beyond the typical few hours for the standard-of-care treatment, tissue plasminogen activator, which is more commonly known as tPA. That intravenous drug is currently the only FDA approved treatment for ischemic strokes.
Pauls said DiaMedica’s DM199, a recombinant form of the KLK1 protein, would be highly beneficial to stroke patients due to the extended period of time patients will have to seek treatment. DM199 can be administered up to 48 hours after the stroke and will then be administered for another 21 days. Pauls said they believe the company can develop a synthetic version of Kailikang that is less costly and has a reduced risk of toxins than the urine-based formula.
“Our synthetic drug will be cheaper and safer,” Pauls said.
The Chinese company, which is backed by Takeda Pharmaceuticals , has deals with multiple state agencies in that country to collect urine, including from the military and schools. Pauls said the company also collects urine from roadside restrooms, which he said raises questions over safety as there are no controls over those who use a roadside facility, compared with possible controls in place in the military and schools.
Techpool currently requires several hundred liters of urine to produce a single treatment for a stroke patient, Pauls said, which has increased the cost of the drug to about the equivalent of $1,500 per patient. He speculated that if they are able to develop DM100 for stroke patients, their cost would be much less, about $1 per treatment.
In addition to possible investors, Pauls said he hopes to use the time at the BIO conference to connect with a Chinese company to develop the treatment there, before seeking approval in the Europe or the United States. Pauls said there has been some interest from other companies in DiaMedica’s DM199, but they’re going to be careful in choosing the right fit to help them move forward with the drug’s development.
Pauls said the company has researched Kailikang for years, ensuring that it is a product that does what it is billed to do. The next step is to initiate an early-stage clinical trial to determine dosing levels of DM199 that closely match the dynamics of the Chinese drug.
“When it comes to China there is a lot of skepticism, but we tracked down about 50 clinical papers and got IMS to verify the data,” Pauls said. “This protein is real… and we think we’ve got a protein here that can be administered and provide a treatment option for stroke patients.”
Pauls said he feels the company is close to naming a potential partner for DM199 by the summer. If things go well, Pauls said the company could initiate a Phase II/III trial next year with a hope of bringing something to market in about four years.
This is not the first time DM199 has been studied for a therapeutic purpose. The product had been previously studied for use in diabetes treatment, but in 2014 it failed to improve the control of glucose levels. This caused the company to undergo a restructuring that led to some layoffs. It also caused the company to refocus the use of DM199 for acute vascular indications. During the diabetes trial, Pauls said one of the key observations researchers noted was a significant improvement in blood pressure. He said the company took a step back to see what the protein could do and began to develop the idea of using DM199 to develop a recombinant form of Kailikang.