Research of the neuroimmune mechanisms involved in stress-related fear revealed how astrocytes interact with neurons in the amygdala. The study, led by Harvard scientists, also unveiled that this interaction recruited monocytes to the meninges during chronic stress and showed how psychedelic compounds reversed monocyte accumulation in the meninges and reduced fear behavior.
Major strides for the company on two fronts – psychedelic therapies and treatment-resistant depression (TRD) – came in the form of Dublin-based GH Research plc’s phase IIb data with GH-001, an inhalable mebufotenin (5-MeO-DMT) activator of serotonin 5-HT2A and 5-HT1A receptors that met not only its primary endpoint but all secondary goals in the TRD experiment. Shares of GH (NASDAQ:GHRS) closed Feb. 3 at $17.99, up $7.39, or 69.7%, on word that the fast-acting, short-duration compound led to a significant reduction from baseline of -15.2 points in Montgomery-Åsberg Depression Rating Scale total score on the eighth day of treatment compared with +0.3 points in the placebo group (a difference of -15.5 points, p<0.0001).
On the heels of positive phase II results of its extended-release ketamine (R-107) in treatment-resistant depression, Douglas Pharmaceuticals Ltd. is gearing up to begin phase III trials of its ketamine treatment that is safe enough to take at home without clinical supervision.
On the heels of positive phase II results of its extended-release ketamine (R-107) in treatment-resistant depression, Douglas Pharmaceuticals Ltd. is gearing up to begin phase III trials of its ketamine treatment that is safe enough to take at home without clinical supervision.
The discussion that preceded the June 4 U.S. FDA advisory committee vote against the approval of Lykos Therapeutics Inc.’s midomafetamine as a treatment for post-traumatic stress disorder could shine some light on the way forward for other sponsors developing psychedelics for approved medical use.
The potential of psychedelic substances such as lysergic acid diethylamide (LSD) and psilocybin in treating various neuropsychiatric disorders has received increased attention in recent times. These compounds are believed to exert their effects through the serotonin 5-HT2A receptor.
Gilgamesh Pharmaceuticals Inc. is getting $65 million up front in an early stage deal with Abbvie Inc. to discover neuroplastogens targeting psychiatric disorders, with the chance to receive up to $1.95 billion in options fees and milestones, plus tiered royalties in the mid-single to low-double digits from any products emerging from the collaboration.
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 long, strange and nowhere-near-concluded trip taken by psychedelic drugs as a therapeutic modality continued in 2023, with regulators in the U.S. and Europe – and, perhaps in greater numbers, investors – warming to prospects in a space that once drew only laughter.
Following the decision of Australia’s Therapeutic Drugs Administration to allow prescribing of MDMA for post-traumatic stress disorder and psilocybin in treatment-resistant depression from July 2023, and with U.S. FDA approval of MDMA for treating PTSD expected in 2024, the EMA is under increasing pressure to set out a path to approval for psychedelics.
