The last couple years have been a bumpy ride for Adeona Pharmaceuticals. The company nearly collapsed in the wake of an FDA rejection of its top drug candidate, Coprexa, in January 2008, and Adeona has had four different chief executives in the last 12 months. Perhaps seeking a divorce from the bad memories, the company in late 2008 changed its name from Pipex Pharmaceuticals, the name it had held since its 2001 inception. But things could be looking up for the drugmaker, with two drugs in clinical trials and an experienced CEO on board. In January, Dr. James Kuo took the helm at Adeona. Previously, Kuo worked as CEO for Cordex Pharma, a California-based cardiovascular drug developer. He was an attractive choice for Adeona because he knows the key issues surrounding the company after serving on its board for nearly three years.
Adeona still hasn’t gotten any drugs to market, but that could change with Trimesta, a multiple sclerosis drug that’s in the midst of what the company calls a “Phase 2/3 trial.” Last month Adeona said it had reached the halfway point in patient enrollment for the trial. A second drug, Zinthionein, is also in trials.
Still new to the job (he wasn’t sure how many full-time employees are on Adeona’s payroll), the reticent yet exceedingly polite Kuo took a few minutes to speak with MedCity News about the latest at Adeona:
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What’s the biggest challenge facing your company right now?
The greatest challenge is developing drugs within our portfolio successfully and efficiently, and that’s what I’m focused on.
Tell us some key bullet points about Trimesta. What is it, and what’s the rough timeline on what needs to happen for it to hit the market?
Trimesta is administered orally and is the name for a molecule called Estriol. Estriol is produced by the placenta in pregnant women and its levels increase in the third trimester. Studies have shown women in the third trimester with autoimmune diseases have remissions in their disease and then when delivery occurs, the disease rebounds. That led researchers to look for the particular molecule causing autoimmune diseases to go into remission. One researcher came up with hypothesis that Estriol is what caused the diseases to go into remission.
Regarding the timeline, I don’t want to go into it. It’s hard to predict and depends on a lot of factors, like things the FDA would ask us to do or patient enrollment, so it’s very hard to predict the timeline of the drug. A clinical trial is currently underway and expected to enroll 150 patients. We expect the clinical trial to continue.
Same drill with Zinthionein.
It’s a proprietary high-dose oral formulation of zinc cysteine, an amino acid, that’s being developed for dietary management, Alzheimer’s and mild cognitive impairment. We currently have a 60-patient clinical trial underway testing it for dietary management of those conditions. We expect the clinical trial to continue.
Why is it an advantage for a company as small as Adeona to be publicly traded?
It depends on what you mean by small. If it’s by number of people, then we’re small. But in some ways I’d say we’re not small because we have a number of drugs in development. In any case, the advantage of being public is greater access to investor capital to finance drug development programs.
What experiences at Cordex best helped you prepare for this role?
Being part of publicly traded company and developing drugs.
Any plans to resurrect Coprexa?
We continue to look at the program. We don’t have any concrete plans to commence development but it’s something we talk about internally.
