The EMA’s chief medical officer has expressed disquiet that Europe has fallen behind in the development of psychedelic drugs as approved therapies for mental disorders, saying they should be given “a second chance.”
The use of psychedelics is seeing impressive results in treating psychiatric disorders like treatment-resistant depression and post-traumatic stress disorder, and Mindbio Therapeutics Ltd. is expanding the field to include microdoses of lysergic acid diethylamide (LSD) to treat depression and premenstrual syndrome.
Based on its analysis of a large cohort of individuals homozygous for the ε4 variant of apolipoprotein E (ApoE4), a multinational team of researchers is arguing that homozygosity for ApoE4 should be considered a genetic form of Alzheimer’s disease (AD).
Philadelphia-based Latus Bio Inc., co-founded by serial biotech entrepreneurs P. Peter Ghoroghchian and Beverly Davidson, launched on May 2 with two lead adeno-associated virus (AAV)-based gene therapy candidates and $54 million in a series A financing.
Shares of Aeon Biopharma Inc. (NYSE:AEON) closed May 3 down $1.66, or 49%, finishing at $1.70 on word that the planned interim analysis of phase II data with ABP-450 (prabotulinumtoxinA) for preventing chronic migraine showed that the compound did not meet the primary endpoint. The Irvine, Calif.-based firm said it has “immediately commenced cash preservation measures and will review all strategic options.”
While Nrx Pharmaceuticals Inc.’s oral antidepressant NRX-101 failed, producing a not statistically significant 33% reduction in suicidality along with a 70% reduction in the symptoms of akathisia, the company said it plans to forge ahead and conduct a registrational study.
A readout of phase III data of buntanetap in Parkinson’s disease is up next as Annovis Bio Inc. tries to recover from the market’s reaction to mixed phase II/III results in Alzheimer’s disease. The company’s stock (NYSE:ANVS) dropped 60% when the data were released on April 29 and continued downward on April 30, with shares closing 23.5% lower at $5.57 each. The shares’ 12-month peak was on Dec. 27 at $19.54 each.
Newron Pharmaceuticals SpA added heft to the data supporting evenamide, reporting positive top-line results from a phase II/III placebo-controlled trial of the glutamate inhibitor in patients with chronic schizophrenia who were receiving a second-generation antipsychotic, but having an inadequate response to that treatment.
Brain Trust Bio Inc. (BTB) will soon begin phase I trials in Australia of its IT-Riluzole delivered to the brain via a continuous intrathecal drug delivery method in people with amyotrophic lateral sclerosis. The company’s concept is to take known drugs that work and make them better by delivering them exclusively to where patients need them most, BTB co-founder and CEO Chen Benkler told BioWorld.
Skyhawk Therapeutics Inc. signed on to work with Ipsen SA in a neurological disease-focused deal worth potentially $1.8 billion to discover and develop novel small molecules that modulate RNA. The deal is an option agreement for exclusive global rights to two candidates. Once the parties have identified and validated those candidates, Paris-based Ipsen will take on all further development and commercialization.