People with neurological and psychiatric diseases often have problems maintaining a medication regimen, typically because of difficult side effects. Even if they do take the drugs as prescribed, effectiveness varies because of systemic dilution.
A newly funded company is aiming to deliver the medicine right to the problem area.
In its first attempt to raise venture capital, Denver-area newcomer Sierra Neuropharmaceuticals (Aurora, Colorado) reported a $21.5 million Series A financing to support its unique drug delivery process. That process makes use of standard implantable pumps to deliver drugs directly to the fluid around the brain via a catheter.
"Clearly the financing is a key milestone in our company's development," CEO Dan Abrams, MD, told Medical Device Daily. "Our company's focus is on a treatment using implantable pumps to deliver medications for high-need patients with central nervous system disorders. It's a big move into that space. Hopefully we'll augur improved outcomes for a great many patients."
Sierra's drug development process makes use of standard implantable pumps — including one from Medtronic (Minneapolis) — that is placed surgically to deliver drugs directly to the brain.
Abrams estimates that more than 10 million people in the U.S. and Europe suffer from severe neurological diseases that are refractory to oral medications and would benefit from Sierra's approach.
"We think Sierra's new approach offers a broad new pathway for treating neurological diseases and a dramatic opportunity to enhance patients' lives," he said.
Sierra's initial indication will be for the treatment of epilepsy, but other potential targets include treatment of depression, schizophrenia and other neurological diseases that, until now, have required orally administered drugs.
"The goal is to decrease systemic dosages," Abrams said. "The whole idea for Sierra came from a clinical discussion at the University of Colorado [Denver] on ways to treat patients with refractory disease. I had experience in treating patients with pain using implantable pumps. We focused on whether this strategy would have an application in serious CNS [central nervous system] disorders."
The company was incorporated in 2005 as a spin-off from the university and it then forged ahead with grant funding. But this week's venture funding is its first major financing infusion and will support the company for up to three years, during which Abrams said initial human clinical trials could be completed.
Sierra says it intends to work closely with both pump manufacturers and pharmaceutical firms to develop life cycle regimes for existing drugs that will now be used at different dosing levels. The company may also explore the development of CNS drugs that offer more therapeutic and commercial potential when delivered via implantable pump.
Its initial products, however, will use off-patent drugs and they are expected to enter clinical trials within the next year.
"As far as we know, no one else is focused on what we are doing," Abrams said. "We've tailored our selection of drugs to diminish side effects. They have the same chemical components, but because of the route of administration, there is significant potential for increased effectiveness. We can use dramatically lower doses to achieve the same or better effects."
Co-leads in the funding were HealthCare Ventures, Morgenthaler Ventures and Sequel Venture Partners. Other investors included High Country Ventures and GC&H Investments.
In other financing news: Bioheart (Sunrise, Florida), a company developing what it calls intelligent devices and biologics that help to monitor, diagnose and treat heart failure and cardiovascular diseases, reported that its shareholders adopted an amendment at the company's annual meeting to increase the number of authorized shares of its common stock from 50 million to 75 million.
Bioheart is developing autologous cell therapies for the treatment of chronic and acute heart damage.
Its lead product candidate, MyoCell, is a muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.