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BioWorld - Sunday, October 1, 2023
Home » Topics » Neurology/Psychiatric, BioWorld

Neurology/Psychiatric, BioWorld
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Illustration of brain in head highlighting the blood-brain barier.

Next episode: Sequel phase II data continue to build Cognition’s sigma-2 story in AD

June 28, 2023
By Randy Osborne
No Comments
With the latest data from the phase II Sequel study, Cognition Therapeutics Inc. added new physiological evidence for the neuroprotective effect of CT-1812 in mild to moderate Alzheimer’s disease (AD) bolstering earlier results related to target engagement and the compound’s impact on cognitive changes. But the results failed to hit statistical significance, and shares of New York-based Cognition (NASDAQ:CGTX) closed June 28 at $2.18, down 32 cents, almost 13%.
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Brain activity concept illustration
Newco news

Enveric Biosciences gears up for phase I anxiety trial with psilocin prodrug

June 22, 2023
By Tamra Sami
No Comments
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
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US FDA adcom supports Leqembi for full approval

June 9, 2023
By Karen Carey
No Comments
Eisai Co. Ltd. and Biogen Inc.’s Leqembi (lecanemab) gained the support of the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (adcom) in a 6-0 vote on June 9, as panel members unanimously agreed that the results of the phase III Clarity trial verified the clinical benefit in the treatment of Alzheimer’s disease. The FDA does not have to follow the adcom’s recommendation, but it often does. The PDUFA date for the supplemental NDA is July 6.
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Elderly woman holding illustration of brain with missing puzzle piece

As diagnostics advance, Parkinson’s sector waits for better therapy

June 7, 2023
By Randy Osborne
No Comments
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies.
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Joel Latham, CEO, Incannex Healthcare Ltd.
Newco news

Incannex is changing treatment paradigms with pipeline of psychedelics and cannabinoids

June 2, 2023
By Tamra Sami
No Comments
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
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Medical cannabis in blister pack of capsules

Zelira’s stock triples as cannabinoid outperforms Lyrica in pain

May 31, 2023
By Tamra Sami
No Comments
Medicinal cannabis company Zelira Therapeutics Ltd.’s stock shot up 224% on May 31 on the heels of news that its cannabinoid product, ZLT-L-007, outperformed Lyrica (pregabalin, Pfizer Inc) in a head-to-head trial in diabetic nerve pain.
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Cerebellum, brain stem, spinal cord

Reprocell reports mixed results for phase II Stemchymal trial in spinocerebellar ataxia

May 30, 2023
By Tamra Sami
No Comments
Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported.
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Joint pain illustration
Newco news

Adolore comes to the fore with CA8 chronic pain gene therapy

May 26, 2023
By Caroline Richards
No Comments
With overuse of opioids – the standard of care for many chronic pain cases – becoming something of an epidemic in the U.S., the availability of an alternative, non-opioid analgesic is a big draw. Established in 2021, Adolore Biotherapeutics Inc. is one company that could provide the answer, with its locally and long-acting gene therapies potentially providing a breakthrough that “knocks everybody’s socks off.”
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Bioxcel has mixed phase III data and tough stock day

May 25, 2023
By Lee Landenberger
No Comments
Mixed phase III study results have Bioxcel Therapeutics Inc. moving ahead to complete the clinical trial while withstanding a hammering from investors. BXCL-501 (dexmedetomidine), a sublingual film being developed to treat bipolar disorders- or schizophrenia-associated agitation, produced clinically meaningful efficacy results in part 1 of the pivotal study with half of the approved dose, but the primary efficacy endpoint was not statistically significant at two hours (p=0.077). BXCL-501 separated from placebo at four hours (p=0.049).
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onward.jpg

Let there be walk: Onward Medical sees first use of movement-restoring lead

May 25, 2023
By Nuala Moran
No Comments
The researchers who enabled patients with spinal cord injuries to walk independently after implanting programmable electrodes below their lesions have now taken things one step further, restoring direct communication from the brain to the spinal cord, enabling the brain rather than an external computer to direct leg movements.
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