BBB and beyond

Lilly, Medtronic collaborate on crossing blood brain barrier to combat Parkinson’s disease

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MINNEAPOLIS, Minn.—Targeted toward a more direct and precise approach to treat Parkinson's disease, pharmaceutical giant Eli Lilly & Co. and medical technology specialist Medtronic Inc. have joined hands to cross the blood brain barrier (BBB) with a potential new medicine to the brain using an implantable drug delivery system.

The partnership will combine the strengths of Indianapolis-based Lilly's biologic, a modified form of glial cell derived neurotrophic factor (GDNF), with Medtronic's implantable drug infusion system technology, the companies announced April 26.

Lilly spokesperson Judy Kay Moore tells ddn, "This 50-50 collaboration highlights the value of two innovative companies coming together to leverage their expertise to hopefully make an impact on the treatment of Parkinson's disease. This collaboration spans early-phase research through development and potential commercialization, allowing both companies to address and resolve questions through all stages of research and development."

Rather than treat the symptoms of Parkinson's with pills or IVs, the collaboration's goal is to deliver the medicine directly to the brain. Lilly's GDNF variant is intended to increase distribution in targeted brain regions, while Medtronic has developed a drug pump and catheter to enable precise delivery of the GDNF variant consistently over time.

"One of the most significant challenges in delivering a biologic treatment for neurodegenerative diseases is crossing the blood brain barrier," says Steve Oesterle, Medtronic's senior vice president of medicine and technology. "We have extensive experience in targeted drug delivery and technology that allow delivery of therapeutic agents directly to the brain."

The BBB is a tightly packed network of cells in brain capillaries that only lets certain substances through, including key nutrients, according to medical experts. The barrier has posed a major challenge for other drugmakers' attempts to treat Parkinson's, as well as Alzheimer's.

Delivering GDNF to the brain has proved extremely difficult for a number of companies, including Amgen, which stopped development of its GDNF
molecule—which used Medtronic's technology—in 2005 as a result of safety concerns, according to Moore.

However, Michael L. Hutton, chief scientific officer of the neurodegeneration team at Lilly, says "we believe we have biosynthetically engineered this GDNF variant to overcome technical hurdles of previous research in this area … and are hopeful that early testing of our biologic with Medtronic's device will provide the necessary data to safely advance into human studies.

"By collaborating with Medtronic from the earliest phase of research, we are maximizing the potential for this therapy's efficient and effective development," Hutton says.
Medtronic spokesman Brian Henry says Medtronic's technology could also be applied to treat Alzheimer's disease and Huntington's, as well as Parkinson's.

While it is "not possible" to gauge the commercial potential of a successful new drug delivery system, the impact on millions of people with Parkinson's and the cost savings to the national healthcare system, "would be huge," Henry says.

Upon hearing the news, Katie Hood, CEO of the Michael J. Fox Foundation for Parkinson's Research (MJFF), was cautiously optimistic.

"While a potential treatment approach resulting from this research is many years away, we are heartened by Lilly's and Medtronic's commitment to develop a neurotrophic-based therapy," Hood said in a press release. The foundation has funded separate, ongoing work in neurotrophic factors for years, she stated, adding "we continue to believe in their promise to lead to a critically needed disease-modifying treatment for Parkinson's."

However, Todd Sherer, MJFF's chief program officer, warns on that there is still much work to do and many hurdles to overcome before this treatment approach can realistically be considered a viable one to treating Parkinson's.

Researchers have demonstrated in preclinical models of neuronal injury and neurodegenerative diseases that increasing the levels of trophic factors can serve to protect the cells in these model systems, Sherer says. From a Parkinson's drug discovery and development standpoint, "this is exciting because in theory, trophic factors could protect the dopamine cells that die in Parkinson's disease."

"While it's early days, the hope is that this combination of a novel GDNF variant, paired with an optimized delivery system, could help overcome some of the technical hurdles that have affected earlier trophic research," Sherer says.

Most importantly, it is encouraging to see well-established companies reaffirming a commitment to trophic factor research, he says.

"MJFF has long been a leader in supporting trophic factor development, and we continue to believe in their promise to yield a next-generation therapy for Parkinson's disease," Sherer says. "But given the many challenges, the more shots on goal that are being taken, the better."

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