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DarPharma betting on D1 agonist for Parkinson's other CNS disorders

Imagine a patient who is completely immobile and bedridden by end-stage Parkinson's disease. The normal course of medication no longer works, and someone must care for this patient 24-hours a day. What if there was a way to get this patient back on his or her feet?

DarPharma Inc. of Chapel Hill is betting it has the potential drug, initially discovered in the laboratories of the company's co-founding scientists at the University of North Carolina at Chapel Hill and Purdue University of West Lafayette, Ind. During experiments in these laboratories, Parkinsonian monkeys were time and again liberated from their immobility with dihydrexidine, the first full D1-dopamine receptor agonist designed and synthesized with the Dendritic Template Diversity(c)(DTD(c)) technology now owned by DarPharma.

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"This was a quantum change in the monkey's mobility, not a minor one," said Dr. Jeffrey Segal, DarPharma's president and CEO.

A viewing of the monkey-study videotape in the office of Richard Mailman, Ph.D., at UNC-CH a couple of years ago, sold Segal on the relevance of Dl -dopamine receptor agonists in the treatment of the disease. It was not long after that moment that Segal, Mailman and David E. Nichols, Ph.D., of Purdue founded DarPharma to develop products around D 1 -dopamine agonists for Parkinson's, and eventually memory/cognition deficits, schizophrenia, attention deficit disorder and other selected CNS-based disorders.

Dopamine is a natural chemical that allows people to move normally. When dopamine is not produced in sufficient quantities, physical symptoms such as rigidity, tremors, slow and shuffling movements and poor balance begin to emerge.

Parkinson's disease has baffled scientists and drug developers for decades, and the hope for successful therapies rested first with dopamine-replacement strategies such as Levodopa.

A chemical cousin of dopamine, Levodopa is the gold standard for the treatment of symptoms. It is administered to replace the missing dopamine and alleviate symptoms in mid- and late-stage Parkinson's patients. But after years of this therapy, and its inevitable combinations with other drugs that extend or improve its efficacy, Levodopa's power over the disease fades.

In recent years, an arsenal of medications have been developed with dopamine agonists, which stimulate one to five of the dopamine receptors in the brain and produce dopamine-like effects. D-2 and D-3 dopamine-receptor agonist drugs are on the market, but researchers now have high hopes for the effectivness of D-l receptor agonists.

This is the stage where DarPharma hopes to make its entrance with the first full D1-dopamine agonist. "We hope to keep them moving," Segal said.

DarPharma's DTD(c) platform is the proprietary technology that has been used to develop the company's prolific collection of Dl-dopamine agonists. Large pharmaceutical entities have so far had difficulty developing safe, commercially viable and orally bioavailable Dl-dopamine agonists.

DAR-201 is DarPharma's first oral drug candidate. The company hopes to file an Investigational New Drug application with the Food and Drug Administration within one year, Segal said. Once this goal is met, the company will move on to test the oral compound for longer term efficacy and safety in Parkinson's patients.

DAR-100, an injectable Dl agonist, has been approved for human testing. If the initial clinical trial is successful, further development will be persued to capture about 100,000 late-stage patients who would immediately benefit from the drug once it is approved.

A neurosurgeon and scientist with entrepreneurial leanings, Segal said he wasn't looking to launch a company. Rather, DarPharma was an offshoot of his efforts to obtain cutting-edge treatment for his autistic son. Along the way, his research on autism led him to Mailman's D1-dopamine agonist work. While autism is not currently one of the first diseases targeted by DarPharma, Segal hopes that one day its research and development will help his son.

DarPharma has so far raised $3.6 million in private funding for its activities, but Segal is gearing up to raise another round of about $20 million. Also, the company is looking to drug delivery companies and big pharma to help with further product development, manufacturing and marketing.

"Big pharma is now at our door, and we are having cordial discussions," he said.

For more information visit the company's Web site at www.darpharma.com.

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DarPharma betting on D1 agonist for Parkinson's other CNS disorders

BT Catalyst, June, 2002

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