Anavex Life Sciences Corp. (NASDAQ:AVXL) and the International Rett Syndrome Foundation, doing business as Rettsyndrome.org announced that it has committed a financial grant of a minimum of $0.6 million to cover the majority of a planned U.S. multicenter Phase 2 clinical trial of ANAVEX 2-73 for the treatment of Rett syndrome.
Scheduled to begin in 2017, the trial will be a randomized, double blind, placebo-controlled study of ANAVEX 2-73 in patients with Rett syndrome lasting up to 12 weeks. Primary and secondary endpoints include safety as well as Rett syndrome conditions such as cognitive impairment, motor impairment, behavioral symptoms and seizure activity. Existing independent pre-clinical research demonstrated that ANAVEX 2-73 improves all of these measures. Hence, ANAVEX 2-73 might have a chance to positively affect a wide range of the symptoms associated with Rett syndrome.
Steven Kaminsky, PhD, Chief Science Officer of Rettsyndrome.org, stated, “This is a very exciting time for us. Pre-clinical data from ANAVEX 2-73 is highly encouraging and demonstrates the potential of this investigational drug to significantly improve Rett patients’ lives. Success in the Phase 2 clinical trial could result in a truly safe and effective drug for this patient population, for which no effective treatment currently exists. We are very motivated to support this trial financially and by involving our knowledgeable clinical and educated community network.”
Rettsyndrome.org sponsored Anavex’s pre-clinical studies of Rett syndrome, which successfully demonstrated benefits from treatment with ANAVEX 2-73. As reported at the 2016 Epilepsy Pipeline Conference and the 2016 Rett Syndrome Research Symposium, ANAVEX 2-73 demonstrated dose-related and significant improvements in an array of behavioral and gait paradigms in a mouse model with a MECP2-null mutation that causes neurological symptoms that mimic Rett syndrome.
“We are delighted to continue our partnership with Rettsyndrome.org and its network of experts to accelerate the clinical development of ANAVEX 2-73 for the treatment of Rett syndrome,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to initiating the planned Phase 2 clinical trial as soon as reasonably possible in 2017.”
Anavex received Orphan Drug Designation from the U.S. Food and Drug Administration’s (FDA) for ANAVEX 2-73 in Rett syndrome on May 18, 2016. The designation provides sponsors with development and commercial incentives, including seven years of market exclusivity in the U.S., prioritized consultation by the FDA on clinical studies and certain exemptions from or reductions in regulatory fees.
Shares of Anavex Life are up nearly 3% to $4.15 in pre-market trading. AVXL has a 1-year high of $8.30 and a 1-year low of $2.43. The stock’s 50-day moving average is $4.07 and its 200-day moving average is $3.89.
On the ratings front, AVXL has been the subject of a number of recent research reports. In a report issued on November 28, Maxim analyst Jason McCarthy maintained a Buy rating on AVXL, with a price target of $15, which implies an upside of 271% from current levels. Separately, on September 29, FBR’s Christopher James reiterated a Buy rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Christopher James have a yearly average loss of 19.4% and 15.9% respectively. McCarthy has a success rate of 27% and is ranked #4284 out of 4355 analysts, while James has a success rate of 30% and is ranked #4269.
Anavex Life Sciences Corp. is a biopharmaceutical company. It is engaged in the discovery and development of new drugs for the treatment of neurological diseases and cancer, utilizing its proprietary drug discovery sigmaceptor platform. The company’s portfolio comprises novel, wholly owned sigma receptor agonists and antagonists.