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Maine biotech testing new drug

The compound is designed to reduce the side effects and addictive properties of opioid-based medications.

via Maine biotech testing new drug | Portland Press Herald.

PORTLAND — After more than 10 years of scientific research, a small Maine biotechnology company is headed to its first round of human trials of a drug designed to reduce the addictive properties and sometimes-debilitating side effects of opioid-based pain medications such as OxyContin and Vicodin.

“There are almost 200 million prescriptions for opioids a year, and many patients can’t take them because of nausea or constipation,” said Dr. Wolfgang Sadee, the founder and chief scientific officer of Aiko Biotechnology. “If we can improve this even very slightly, this would be a major advance in pain therapy.”

Earlier this month, the Food and Drug Administration gave Portland-based Aiko approval to begin preliminary Phase 1 testing of its compound, known as Aiko-150. The company expects to begin testing soon in San Francisco with eight people who are on methadone maintenance programs.

In very simple terms, the Aiko compound works like a dimmer switch for the negative side effects of opioids.

An opioid works by binding to proteins called opioid receptors in the brain, spinal cord, and gastrointestinal tract and turning them “on,” triggering both pain relief by blocking the perception of pain, and sometimes, inducing negative side effects such as gastrointestinal problems.

In theory, the Aiko compound works in a two-stage process to compete with the opioid to bind to the same receptors. The compound initially takes effect in the GI tract, keeping a certain percentage of receptors “busy” – the “dimmer” effect – and therefore immune to opioid binding, alleviating GI distress. If the patient takes too many pills, the Aiko compound builds up in the system, eventually taking effect on the receptors in the brain, and denying users the “high” that comes from overuse.

Ultimately, the effect of the hoped-for drug would be two-fold. If added to an opioid, such as OxyContin, a person could take the drug as prescribed and not get constipated, which happens for 95 percent of the users. Secondly, a person who took too much of the drug wouldn’t get high.

“That’s the home run,” said Janet Yancey-Wrona, chief operating officer for Aiko.

The path from scientific idea to creation of a new drug is a very long and expensive one, company officials acknowledge. Generally, it takes $1 billion to develop a new drug, and 95 percent of the potential drugs that make it to human testing ultimately fail.

Drugs must pass three phases of testing: Phase 1, where safety is tested, as well as Phase 2 and larger Phase 3 trials, when the efficacy of the drug is tested. Once the trials are complete, a company files the data with the FDA. The agency usually takes six to 10 months to determine whether to approve the drug for market.

Despite these long odds, Aiko executives say they are optimistic.

“While it’s not a sure thing by any stretch, I think we’ve made incredible progress to get it to the stage that it’s at,” said Aiko Chairman Victor Otley, who heads up the business side of Aiko Biotechnology.

Financially, the company has operated on a shoestring budget, raising about $1 million in seed funding from investors and a handful of small grants. The two scientists who founded the company have kept their university jobs, and executive officers do not draw a salary, hoping to make their money if the venture is successful. Only a lab technician and one executive are currently compensated.

Scientifically, Aiko-150 is made up of what is called a “metabolite,” or material that results from metabolism.

Specifically, Aiko-150 is a metabolite of Naltrexone, a treatment for alcoholism, which has been used in thousands of people without safety or toxicity issues – a major hurdle in drug development.

Finally, the demand for a potential treatment to stem addiction and negative side effects has grown tremendously in recent years as opioid use and abuse have grown. Opioids are a wide class of drugs, from heroin and morphine to such commonly prescribed pain medications as hydrocodone, oxycodone and Vicodin.

Federal data show that opioid prescriptions jumped from about 40 million in 1991 to nearly 180 million in 2007, while deaths from prescription opioids increased 160 percent from 1999 to 2004. By 2004, opioid painkiller abuse deaths outnumbered all the deaths caused by heroin and cocaine, according to the Centers for Disease Control and Prevention.

“We should be seriously concerned,” said Dr. Nora Volkow of the National Institute on Drug Abuse, an agency of the Department of Health and Human Services, in testimony last March before a Senate committee on the latest research on prescription drug abuse.

The opioid crisis is one reason Aiko’s compound is so promising, said Dr. John Mendelson, who will conduct the preliminary Phase 1 trials in San Francisco and specializes in substance abuse.

“There is a big epidemic of opioid abuse in the United States,” he said. Many people wind up on methadone, then stay on it for the rest of their lives.

“There’s a blurry line between addiction and pain treatment in some patients,” he said. “Part of crossing that line is because patients can escalate their opioid doses without any medical control. If we are right about this compound, it will be almost impossible to escalate their doses.

“If it works, it will be very exciting,” Mendelson said.

Aiko’s approach, he said “is a very interesting concept,” said Gary Nachman, an analyst for New York-based Leerink Swann, a health-care-focused investment bank.

“They’ve definitely tapped into a market where I think there is significant potential, but it’s still a very early stage,” Nachman said. “Can they find a partner? There are a lot of companies interested in this space.”

Nachman, who represents two companies already working on similar drugs, said there are many companies also working to make opioids less addictive and safer.

“Some of these companies are very far along,” Nachman said, referring to two drugs that have completed Phase 3 testing and are awaiting final approval from the Food and Drug Administration. They might be on the market within months, he said.

Yancey-Wrona said the results from Mendelson’s work will be critical to Aiko attracting a major financial partner who can finance future testing. Potential partners, she said, usually don’t get involved until they see human trial data.

“Our hope is that (preliminary Phase 1 data) will be enough,” Yancey-Wrona said.

Now that the company has reached human trials, federal regulations become much more rigorous, and Yancey-Wrona said Aiko will start outsourcing much of the research.

Co-founder Sadee said he is very pleased to finally be at this stage. He is the chairman of the Department of Pharmacology at Ohio State University in Columbus. He started work more than 10 years ago with Aiko co-founder Ed Bilsky, then a graduate student in New Mexico and now an associate professor in the School of Pharmacology at the University of New England in Biddeford.

“It was a new idea at the time, a little bit unorthodox really, and I immediately saw the potential clinically,” Sadee said. The two collaborated while continuing their other work, finally deciding to form Aiko and hire several people to run the business side of the company in 2006.

“Maine turned out to be a good business climate,” Sadee said. “There are a lot of people well versed in biotechnology that live there, and the business climate is rather favorable in terms of investments and fostering this type of business.” The proximity to Boston probably helped, he said, but Aiko’s work so far demonstrates that drug development can take place outside of “biotech hotbeds” like the San Francisco Bay area or Boston.

Yancey-Wrona, who previously served as the director of Maine’s Office…

of Innovation, said she isn’t aware of any other drug-development companies in Maine. Most biotechnology companies here, she said, make tools and supplies for the biotech sector.

Aiko faces several more stages of human testing. If the results from the exploratory Phase 1 testing are inconclusive, it will have to do more exploratory trials. If Aiko gets good results, it can move on to Phase 1 testing, which involves safety. Only at Phase 2 will it begin to address whether the drug is effective.

Even if all goes well, testing wouldn’t be done before the end of 2010, and it could not get a drug to market before 2011 at the earliest.

“I’m delighted it’s going forward,” Sadee said. “I’m pretty enthusiastic about this.”

As important as the science is to Aiko’s success, Sadee said the company wouldn’t have been able to progress without its business team: Otley and Yancey-Wrona.

“We thought, ‘Oh, we have this product, the money will just flow to us,’ ” Sadee said with a laugh. “Well, it doesn’t work that way.”

Otley, who has a background in developing emerging companies in various sectors, said the scientific work and early financial support persuaded him to join Aiko.

“I look at opportunities all the time, and what intrigued me about this opportunity was how far along they were given the stage of the business,” Otley said. “We thought there was a real opportunity to get the compound into human trials.”

Once on board, Otley and Yancey-Wrona imposed strict business discipline on the principals, began outreach to potential partners and solicited funding. Since they joined the company, Aiko closed a seed round of funding worth about $600,000, received two Maine Technology Institute grants and a grant from the National Institutes for Health.

“We are advancing this company toward a very definitive goal,” Otley said. “From the beginning, we maintained that we were a discovery company, and we knew we were not the group that’s going to take (the compound) through the late stages. We hope to partner with someone in the industry.”

Until then, Otley keeps the company on an annual plan with rolling three-month goals.

“We’ve got a high-level plan on what to accomplish, and we do it in 90-day sprints,” he said. “At the end of every 90 days, we step back and assess. By combining business discipline and science, we bring real rigor and accountability.”

Staff Writer Noel K. Gallagher can be contacted at 791-6387 or at:

ngallagher@pressherald.com


					
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