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Wayne State U and MITRI Partner to Move Neuro Rx Candidates to Clinical Trials

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The Michigan Technology and Research Institute and Wayne State University have partnered to commercialize three small molecule compounds developed by WSU researchers with the potential to treat an array of neurological conditions, the university said this week.

As part of their deal, MITRI and WSU have inked a letter of intent to form a company to ready for clinical trials the most advanced of the compounds, a small molecule triple-uptake inhibitor for treating depression, at which point they hope to attract a pharma partner for further development.

The partners will also eventually develop small molecules for treating Parkinson's disease and dementia; and one for treating substance abuse, officials from MITRI and WSU said this week.

To fund the company's formation and additional research on the first potential therapeutic, the partners will likely seek between $10 million and $20 million in venture capital, Felix de la Iglesia, president of science and strategy at MITRI, told BTW.

"We will set up the company to license the IP [from WSU]," said de la Iglesias. "Once the company is established and we secure funding, we will start developing the plan, and then use different contractors to execute different parts of the plan."

Randy Ramharack, a technology licensing manager at Wayne State University, added that the partners will "develop an extensive business and detailed drug-development plan to get the drug to, say, Phase I clinical trials. And with our experimental data and plan, we're going to seek venture funding for this new company."

All three of the small-molecule platforms were developed in the laboratory of Aloke Dutta, a professor of pharmaceutical sciences at WSU's Eugene Applebaum College of Pharmacy and Health Sciences.

The first drug candidate, a so-called triple-uptake inhibitor, is thought to be an improvement over existing antidepressants such as selective serotonin reuptake inhibitors and dual serotonin/norepinephrine inhibitors, which address only serotonin and norepinephrine imbalances in the brain.

In contrast, TUIs (also called triple reuptake inhibitors, or TRIs) inhibit a third major neurotransmitter, dopamine, and it is hoped that this added component may make the drugs more efficacious than SSRIs or SNRIs.

"One of the research goals will be to study whether such novel [TRI] molecules have more desirable therapeutic profiles as antidepressant agents compared to the current existing drugs, and whether their chronic exposure might sustain effectiveness and lower the incidence of side effects," Dutta said in a statement.

So far, using undisclosed funding from the Michigan Universities Commercialization Institute, Dutta's lab has shown that the TRIs exhibit activity in animal models that indicate antidepressant activity – a long way from demonstrating that the drug might be safe and effective in humans.

To that end, Dutta's lab will work closely with Ann Arbor-based MITRI, which was founded in late 2006 primarily by several former employees of the Michigan laboratories of Pfizer and Parke-Davis (which was acquired by Pfizer in 2000).

According to co-founder de la Iglesia, who once served as vice president of preclinical worldwide safety at Parke-Davis/Pfizer, MITRI has a three-pronged business plan.

"One is that we're a general consulting company for the pharmaceutical industry, and the second is that we manage projects in their entirety for certain pharma and biotech companies," de la Iglesia said.

MITRI's third arm, which is responsible for the WSU partnership, "organizes a company with a sponsor like WSU, which provides the IP, and then we transform that into a company and [seek funding] and nurture it in its early stages," de la Iglesia said.

In this way, MITRI is not entirely different from an incubator or tech-commercialization firm, except that its team has more than 90 years of combined pharmaceutical industry experience.

"These guys really understand drug development and are top-notch toxicologists," Ramharack said. "They've had experience getting several drugs to market, and they have expertise in … moving university technologies out to the commercial market."

According to de la Iglesia, a private consulting group he founded prior to MITRI already tested this commercialization model by helping spin out QRxPharma in 2002 from research conducted at the University of Queensland in the late 1990s. In 2007, QRxPharma, which develops treatments for pain management and central nervous-system disorders, began trading on the Australian Securities Exchange under the symbol “QRX.”

"They have really good relationships with VCs, and have been successful in the past with other deals," Ramharack said. "It's not like the blind leading the blind. It's a real partnership – we've got the science, and they've got the ability to move the project forward."

MITRI is now in the process of tapping those VC relations to secure enough funding to move the WSU technology along. At some point the partners will incorporate a separate company to license the IP from WSU, "and then MITRI, depending on the relationship with the venture capitalist, might take an equity stake," Ramharack said.

"The key is going to be getting the funding to [reach] Phase I," he added. "The end game is to partner with big pharma to take it further. Maybe the company itself can get enough capital to take this all the way to market, but typically you'll need the resources of big pharma to commercialize something like this."

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