Amarantus Bioscience Holdings, Inc. (OTC: AMBS), a US-based JLABS-alumnus biotechnology holding company developing proprietary orphan neurologic, regenerative medicine and ophthalmic therapies and diagnostics through its subsidiaries, today announced that subsidiary Elto Pharma, Inc. has received a notice of allowance from the European Patent Office (EPO) covering the use of eltoprazine and eltoprazine in combination with a number of chemical compounds, including cannabidiol (CBD) in the treatment of Parkinson’s disease and Parkinson’s disease levodopa-induced dyskinesia (PD-LID). Once issued, the patent will protect the use of eltoprazine in the treatment of Parkinson’s and PD-LID through 2034. Elto Pharma is focused on the development of eltoprazine as an oral formulation for the treatment of PD-LID, Adult ADHD and Agitation in Alzheimer’s disease.
“The notice of allowance from the EPO underscores the potential for eltoprazine in combination with CBD, or chemical compounds, to treat Parkinson’s disease,” said Gerald E. Commissiong, President & CEO of Amarantus and interim-CEO of Elto Pharma. “The potential for cannabinoid pharmaceuticals is rooted in their potentially synergistic effects with other traditional pharmaceutical compounds, such as eltoprazine. We are very pleased with this first notice of allowance that we’ve received from this international patent family, and we expect to receive many more in the months from jurisdictions around the world, including the United States.”
Clinical data for Eltoprazine in PD-LID
The Eltoprazine study in 22 subjects with long standing PD-LID was a randomized, four-way crossover design in which patients received a single dose of placebo and eltoprazine, at 2.5, 5 and 7.5 mg, in combination with a challenge dose of levodopa (1.5 times usual dose), on four different days, separated by an interval of a week. Data from the study demonstrated that eltoprazine significantly reduced peak dose dyskinesia at both the 5 (p<0.05) and 7.5 mg (p<0.05) doses using the Combined Dyskinesia Rating Scale. The 5 mg dose also showed a significant anti-dyskinetic effect on other measures of dyskinesia, including the Rush dyskinesia rating scale. Importantly, there were no adverse effects on levodopa efficacy at any dose level as evidenced by United Parkinson’s Disease Rating Scale (UPDRS Part III) observation. Additionally, all dose levels of eltoprazine were well tolerated with no major adverse effects reported. A link to the publication of the PD LID clinical data is provided here:
Amarantus has entered into a binding term sheet for Elto Pharma to license eltoprazine to Emerald Organic Products. The transaction is expected to close in the fourth quarter of 2019.
About Elto Pharma, Inc.
Elto Pharma, Inc. is developing eltoprazine, an oral small molecule 5HT1A/1B partial agonist in clinical development for the treatment of Parkinson’s disease levodopa-induced dyskinesia (PD-LID), aggression in Alzheimer’s disease and adult attention deficit hyperactivity disorder (adult ADHD). Eltoprazine has been evaluated in over 680 human subjects to date, was well-tolerated and showed promising efficacy results in both cognitive and movement disorders. Eltoprazine has received orphan drug designation (ODD) from the US FDA for the treatment of PD-LID. Eltoprazine was originally developed by Solvay (now Abbvie) for aggression-related indications. The eltoprazine program was out-licensed to PsychoGenics, Inc. (PGI). PGI licensed eltoprazine to Amarantus in 2014 after a successful proof-of-concept trial in PD-LID.
In April 2017, Amarantus incorporated the wholly-owned subsidiary Elto Pharma, Inc. for the purpose of raising capital to finance the further clinical development of eltoprazine.
About Amarantus Bioscience Holdings, Inc.
Amarantus Bioscience Holdings (AMBS) is a JLABS alumnus biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases through its subsidiaries. The Company‘s 80.01%-owned subsidiary Breakthrough Diagnostics, Inc., currently a joint venture with Todos Medical, Ltd. has licensed intellectual property rights to the Alzheimer’s blood diagnostic LymPro Test ® from Leipzig University that was originally developed by Dr. Thomas Arendt, as well as certain rights to multiple sclerosis diagnostic MSPrecise™ and Parkinson’s diagnostic NuroPro. Amarantus entered into a joint venture agreement with Todos Medical, Ltd. to advance diagnostic screening assets, and Todos has exercised its exclusive option to acquire Amarantus’ remaining ownership in Breakthrough in exchange for approximately 50% ownership of Todos. The transaction is expected close before the end of the first quarter of 2020. Amarantus also owns approximately 30% of the common shares of Avant Diagnostics, Inc., a healthcare data-generating technology company that specializes in biomarker assay services that target multiple areas of oncology. Avant provides precision oncology data through its TheraLink® assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders, initially for breast cancer, to over 70 FDA-approved drug treatments.
AMBS 50%-owned subsidiary Elto Pharma, Inc. has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson’s disease levodopa-induced dyskinesia, Alzheimer’s aggression and adult attention deficit hyperactivity disorder, commonly known as ADHD. AMBS acquired Cutanogen Corporation from Lonza Group in 2015. Cutanogen is preparing for pivotal studies with Engineered Skin Substitute (ESS) for the treatment of pediatric life-threatening severe burns. ESS is a regenerative medicine-based, autologous full-thickness skin graft technology originally developed by the Shriner’s Hospital that can be used to treat severe burns, as well as several other catastrophic and cosmetic dermatological indications. AMBS’ wholly-owned subsidiary, MANF Therapeutics Inc. owns key intellectual property rights and licenses from a number of prominent universities related to the development of the therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor (“MANF”). MANF Therapeutics is developing MANF-based products as treatments for ophthalmological disorders such as Wolfram Syndrome, retinitis pigmentosa and glaucoma, as well as neurodegenerative diseases such as Parkinson’s disease. MANF was discovered by the Company’s Chief Scientific Officer John Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS’ proprietary discovery engine PhenoGuard, from which other neurotrophic activities remain to be characterized. Amarantus has entered into a binding letter of intent to license the therapeutic assets from Elto Pharma, Cutanogen and MANF Therapeutics to Emerald Organic Products.