An $850,000 investment will help Grand Rapids-based Tetra Discovery Partners LLC move into clinical trials next year for a drug under development to treat Alzheimer’s disease.
Tetra Discovery plans to start early-stage Phase I human clinical trials in September 2015, entering a new stage in a lengthy and costly process to bring a new drug to market.
Grand Angels and the venture capital subsidiary of pharmaceutical giant Johnson & Johnson participated in the most recent round of fundraising.
A follow-up Phase II clinical trial will cost about $10 million to conduct and a later-stage, large-scale Phase III trial required for application to the U.S. Food and Drug Administration will take an estimated $150 million.
Securing the Johnson & Johnson Development Corp. investment can provide Tetra Discovery support beyond the capital the firm provided as the company moves through clinical trials and the drug-development process in the years ahead, said Chairman and CEO Mark Gurney.
“Because we’re a small company, we’re very much dependent on advisers and collaborations,” Gurney said. “The investment by J&J gives us the possibility of seeking advice from them about the quality of our programs and our plans for the clinical trials.”
Tetra Discovery operates out of the business incubators GR Current in Grand Rapids and the Southwest Michigan Innovation Center in Kalamazoo.
Gurney estimates the company is six to seven years away from bringing the drug to market. Presuming the clinical trials will prove its safety and efficacy, Tetra Discovery aims to further develop and commercialize the drug with a partner, he said.
“We need a larger partner with expertise that can supplement what we do and that also would provide the funding, so we are looking for a deal that would be co-developing, co-marketing,” Gurney said.
Supported by capital investments and $15.3 million in grants from the National Institutes of Health, Tetra Discovery is already working on future equity financing and is “in discussions with several top venture capital firms,” two of which are based in Boston.
“At the same time, we are pursuing partnering discussions and we have three pharmaceutical companies in various stages of diligence with the Alzheimer’s drug,” Gurney said.
In addition to Grand Angels and J&J Development Corp., the latest investment in Tetra Discovery included Muskegon Angels, Invest Michigan 2.0 and the Biosciences Research & Commercialization Center in Kalamazoo.
Grand Angels previously invested in Tetra Discovery.
The latest investment round, which closed in two phases on Oct. 14 and in July, represents the first time J&J Development has partnered with an angel group, Grand Angels President Jody Vanderwel said.
“It means a wonderful validation of the potential of Tetra and could open other doors for Tetra,” Vanderwel said. “Secondly, I think it shows that Michigan angel deals are worth a look by not only national VCs but national big pharma venture companies.
“This could be a real nice enhancement to what’s happening in the early-stage investment in the state of Michigan.”
Once a pending deal closes in the near future, Grand Angels will have invested in 12 deals so far in 2014 totaling $2.4 million, exceeding a goal going into the year for 11 deals and $2.3 million. The Holland-based angel group has also grown to 50 members.
Tetra Discovery’s Phase I clinical trial will test the drug’s absorption of a single dose into the blood stream and how well people tolerate it. The first study will involve 40 healthy volunteers.
A subsequent second study involving 60 healthy volunteers, including elderly persons, will test for absorption levels and for the drug’s safety and tolerance in multiple doses, Gurney said.
After those initial studies, which will take about a year, Tetra Discovery will move into a Phase II clinical trials involving Alzheimer’s patients to see if they experience improvement in learning and memory. Pre-clinical trials involving animals indicated the drug has promise in treating learning and memory functions.
The drug has potential applications beyond Alzheimer’s for treating traumatic brain injuries, rehabilitation after a stroke, and perhaps Parkinson’s disease, Huntington’s disease and schizophrenia, Gurney said.