Dong-A Ties With NeuroBo For Diabetic Neuropathy, Alzheimer's
Executive Summary
Dong-A makes notable progress in botanical drug programs, reaching deals for its diabetic neuropathic pain and Alzheimer's disease drug assets with Boston-based NeuroBo Pharmaceuticals.
Dong-A ST Co. Ltd. has begun the new year on a positive note, licensing out its botanical drug candidate for diabetic neuropathic pain as well as selling its botanical drug program for Alzheimer's disease to Boston-based NeuroBo Pharmaceuticals, marking noteworthy progress in the global entry of its botanical drugs.
Under the licensing agreement, Dong-A ST has granted the global development and commercialization rights of DA-9801, its botanical drug candidate for diabetic neuropathic pain, to NeuroBo, in a deal worth $180m plus sales royalties. The South Korean pharma will receive an upfront payment of $2m and a 5% stake in NeuroBo as well as up to $178m in milestone payments, plus sales royalties.
NeuroBo will handle global clinical development, regulatory approval and sales of DA-9801, which has completed a Phase II US study. However, Dong-A will retain the drug's exclusive sales rights in South Korea.
Dong-A also additionally agreed to sell DA-9803, its botanical drug candidate for neurodegenerative disease, to NeuroBo. The US firm will acquire the asset and proceed with global development, while Dong-A will receive $5m and a 24% stake in NeuroBo in return.
DA-9803, which is said to inhibit formation of beta-amyloid, increase neurotransmitters and protect neurons, has completed a preclinical study in South Korea and is poised for an IND filing in the US.
NeuroBo, which aims to develop natural product based drugs with a focus on neuroscience, was jointly established by JK BioPharma Solutions and Dr. Roy Freeman, professor of neurology at Harvard Medical School and director of the Center for Autonomic and Peripheral Nerve Disorders in the department of neurology at Beth Israel Deaconess Medical Center in Boston. Dr. Freeman has played a key role in DA-9801's Phase II US study and also participated in clinical trials of Pfizer's Lyrica (pregabalin), Dong-A said.
With the latest deals, Dong-A is set to become a major shareholder of NeuroBo, holding a 29% stake in total.
DA-9801 Progress, Study Results
DA-9801 contains herbal ingredients from dioscorea rhizome and dioscoreae nipponicae rhizoma to treat diabetic neuropathic pain, and is said to have pain relieving and nerve regeneration effects. The company successfully completed the Phase II US study in 2015 and is gearing up for a Phase III study in the US.
During the Phase II US study, pain reduction of 128 patients in type 1 and 2 diabetes was assessed by the Likert numerical rating scale (NRS) for 12 weeks. The dose-ranging and placebo-controlled study was conducted in diabetes patients with neuropathy pain for at least three months prior to the study across 14 sites including Johns Hopkins University.
DA-9801 demonstrated significant effectiveness over placebo and 50% of the patients who received DA-9801 showed a 50% decrease in pain. (Also see "Dong-A Progresses In Diabetes With Lat Am Deal, New Study" - Scrip, 22 Apr, 2015.)
Biomedtracker has estimated the drug's likelihood of approval of DA-9801 at 17%, the same as the average.
According to Dong-A ST, the global diabetic neuropathy treatment market is estimated to be worth about $2.5bn, with the US accounting for more than 70% of the major seven countries. At present, the main FDA-approved treatments for diabetic neuropathic pain are anticonvulsants and antidepressants, but because of their possible side-effects, the need for new therapies has been growing.
Competition With ViroMed's VM202
Datamonitor Healthcare analyst Sultan Khan told Scrip that if DA-9801 has nerve regeneration capabilities as Dong-A claims, it would be very well received. But he is skeptical amid a lack of available data.
Furthermore, DA-9801 has direct competition in the form of VM-202 (ViroMed Co. Ltd.), an intramuscularly injected gene therapy indicated for diabetic peripheral neuropathic pain (DPNP). VM202 is currently in Phase III, having successfully achieved 50% reduction in pain, in 48% of its patients with a favourable side effect profile mainly consisting of injection site reactions, he said.
"Given its oral formulation, provided DA-9801 can replicate its Phase II trial data in Phase III it would most likely be the preferred option out of the two," the analyst said.
Khan added that ViroMed has also claimed nerve regeneration based on its pharmacodynamics, but this claim is yet to be validated.
VM202 (donaperminogene seltoplasmid) is a DNA-based drug that is designed to produce two isoforms of HGF (hepatocyte growth factor) HGF728 and HGF723. When VM202 is delivered to the affected area by a single intramuscular injection, this drug enters a small portion of the surrounding muscle cells. HGF induces angiogenesis and acts as a neurotrophic factor leading to the formation of new microvasculature and nerve cells.
ViroMed is developing VM202 as the first gene therapy globally for painful diabetic peripheral neuropathy (PDPN) and peripheral artery disease (PAD). The company is progressing late phase clinical trials in the US and has also recently received approval from China CFDA to start a Phase III study for the treatment of critical limb ischemia. (Also see "Momentum For ViroMed's Gene Therapy After ‘Exceptional’ Trial Go-Ahead In China" - Scrip, 18 Oct, 2017.)
Biomedtracker has estimated the drug's likelihood of approval for VM202 for diabetic peripheral neuropathy at 52%, the same as the average approval rate.
From the editors of PharmAsia News.
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