Type of information: Establishment of a new subsidiary in the US
Company: Amarantus BioScience (USA – CA) Elto Pharma (USA – CA)
Therapeutic area: CNS diseases
Type agreement: establishment of a new subsidiary in the US
Details: • On April 17, 2017, Amarantus Bioscience Holdings, a US-headquartered biotechnology company focused on developing products for regenerative medicine, neurology and orphan diseases, announced that it has formed a wholly-owned subsidiary named Elto Pharma, for the purpose of creating investment vehicles focused exclusively on the further development of eltoprazine. The product has completed Phase 2 clinical studies in adult attention deficit and hyperactivity disorder (ADHD), Alzheimer's aggression and Parkinson's disease levodopa-induced dyskinesia (PD-LID). Going forward, Elto Pharma will conduct an analysis of the competitive landscape, commercial opportunity and investor appetite for each indication ahead of selecting the lead indication to pursue for further funding and renewed clinical development. ¤The Phase 2 human clinical trial demonstrated that at both 5mg and 10 mg, the study met its Primary endpoint as measured by change from baseline in ADHD-RS-IV score in 5mg (p=0.003) and 10mg (p=0.037) doses which were statistically significantly superior to placebo with approximately 25% greater efficacy compared to placebo. Total ADHD-RS-IV scores improved by 13.6, 17.9 and 17.4 points from baseline for placebo, 5mg and 10mg of eltoprazine, respectively. Inattention, Hyperactivity, and Impulsivity ADHD-RS-IV subscales were also analyzed. For the Inattention subscale, both 5mg and 10mg groups showed a statistically significant benefit over placebo (0.003 and 0.039, respectively). For the Hyperactivity subscale, the 5mg dose showed a statistically significant benefit in favor of Eltorprazine treatment compared to placebo (p=0.008); the 10mg dose was superior to placebo, however the difference was not statistically significant (p=0.130). For the Impulsivity subscale, no significant benefit was observed for either drug dose compared to placebo. Both 5mg and 10mg demonstrated significantly greater improvement over placebo for CGI-I scores (p=0.023 and 0.004, respectively). The percentage of subjects who were considered improved by the investigator was 57.9% for placebo, 68.4% for 5mg, and 81.1% for 10mg. The percentage difference was significant between 10mg and placebo (0.029), but it was not between 5mg and placebo (p=0.342). ¤ The eltoprazine study in 22 subjects with long standing Parkinson's levodopa-induced dyskinesia 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.