Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Jan. 23 to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19.
Orexin OX2 receptor agonists have demonstrated the ability to enhance wakefulness in rodent models, as well as in nonhuman primates and patients with narcolepsy and idiopathic hypersomnia. Based on recent findings, it has been hypothesized that they may also regulate cognition, mood and other neuropsychiatric functions. Furthermore, dysregulated orexin signaling has been reported in patients with major depressive disorder (MDD) with suicide attempts.
About one-third of patients with major depressive disorder (MDD) are treatment resistant. Ketamine is very effective in treatment-resistant depression, but it is associated with psychotomimetic effects. Metabotropic glutamate mGlu2 and mGlu3 receptors negatively regulate the release of glutamate and are involved in the pathogenesis of depression.
Neuroplastogens are an emerging class of compounds that promote neuroplasticity in the brain without inducing hallucinogenic effects. Transneural Therapeutics Inc. has presented data regarding their new neuroplastogen TN-001 for treating major depressive disorder; TN-001 was assayed in vitro and in vivo.
For individuals with major depressive disorder (MDD) that does not respond to pharmacotherapy, recent decisions by the U.S. FDA enabling at-home use of neuromodulation devices may provide a bright spot in dark days. Neurolief Ltd. received FDA premarket approval for Proliv Rx, a physician-directed, brain neuromodulation therapy indicated for use as an at-home adjunctive treatment for adults with MDD who failed to respond adequately to at least one previous antidepressant on Jan. 7. That decision follows the December 510(k) clearance for at-home use of the Flow brain-stimulation device by Flow Neuroscience AB as either a monotherapy or as an adjunctive treatment.
Flow Neuroscience AB received U.S. FDA 510(k) approval for its Flow at-home brain-stimulation device to treat major depressive disorder. The wearable headset uses mild electrical current to stimulate specific areas of the brain to reduce depressive symptoms in as little as three weeks.
In another deal between the two companies that could be worth more than $1 billion, Abbvie Inc. is buying Gilgamesh Pharmaceuticals Inc.’s lead candidate bretisilocin (GM-2505) for up to $1.2 billion, including an undisclosed up-front payment and development milestones. Privately held Gilgamesh has the psychedelic compound for treating moderate to severe major depressive disorder in a phase II study.
Draig Therapeutics Ltd. launched with a $140 million series A and an AMPA receptor modulator program that has completed phase I and will start a phase II trial in major depressive disorder later in 2025. The series A also will enable the company to advance two small-molecule GABA receptor modulators that have the potential to treat a range of neuropsychiatric disorders, into the clinic in 2026.
