Dyskinesia

Clearmind Medicine CEO Issues Letter to Shareholders

Retrieved on: 
Tuesday, April 9, 2024

Recently, our efforts reached a key inflection point as the Israeli Ministry of Health approved our Phase I/IIa clinical trial for CMND-100 for AUD.

Key Points: 
  • Recently, our efforts reached a key inflection point as the Israeli Ministry of Health approved our Phase I/IIa clinical trial for CMND-100 for AUD.
  • CMND-100, a pioneering MEAI-based (5-methoxy-2-aminoindane) formula, has exhibited encouraging results in pre-clinical studies.
  • Notably, it has shown the ability to disrupt the destructive cycle of binge drinking without inducing hallucinations—a common concern with existing treatments.
  • The journey ahead is filled with potential, and we eagerly anticipate sharing impactful updates with our shareholders."

Addex and Perceptive Launch Neurosterix with $63 Million to Accelerate Development of Allosteric Modulator Therapeutics for Neurological Disorders

Retrieved on: 
Wednesday, April 3, 2024

With initial funding of $63 million from Perceptive Xontogeny Venture Fund II, with participation from Perceptive Life Sciences Fund and Acorn Bioventures, Neurosterix will acquire a portfolio of preclinical assets and the allosteric modulator drug discovery technology platform from Addex and accelerate their development.

Key Points: 
  • With initial funding of $63 million from Perceptive Xontogeny Venture Fund II, with participation from Perceptive Life Sciences Fund and Acorn Bioventures, Neurosterix will acquire a portfolio of preclinical assets and the allosteric modulator drug discovery technology platform from Addex and accelerate their development.
  • In return, Addex will receive CHF5 million and a 20% equity interest in Neurosterix.
  • “The launch of Neurosterix in partnership with Perceptive is an important validation of the Addex allosteric modulator drug discovery technology platform and provides the resources to accelerate development of important preclinical assets, including the M4 PAM and mGlu7 negative allosteric modulator (NAM) programs, into the clinic,” said Tim Dyer, CEO of Addex.
  • To guide the launch of Neurosterix, Tim Dyer, in addition to his role at Addex, will assume the role of CEO of Neurosterix.

S.BIOMEDICS completes brain transplant of hESC-derived dopaminergic progenitors (TED-A9) for Phase 1/2a study in patients with Parkinson’s disease

Retrieved on: 
Thursday, February 29, 2024

S.BIOMEDICS Co., Ltd. (KOSDAQ: 304360) announced that it has successfully completed the brain transplant of TED-A9 (hESC-derived dopaminergic progenitors) for Phase 1/2a study for treating Parkinson's disease.

Key Points: 
  • S.BIOMEDICS Co., Ltd. (KOSDAQ: 304360) announced that it has successfully completed the brain transplant of TED-A9 (hESC-derived dopaminergic progenitors) for Phase 1/2a study for treating Parkinson's disease.
  • The primary objective of the Phase 1/2a trial is to assess the safety and exploratory efficacy of TED-A9 transplantation for two years post-transplant.
  • “We have developed a fundamental therapeutic mechanism that directly replaces dopaminergic neurons lost in patients with Parkinson's disease.
  • TED-A9 could represent a fundamental treatment that surpasses current therapies, which only temporarily alleviate the symptoms of Parkinson’s disease,” he added.

Rune Labs Unveils $12 Million Strategic Round to Accelerate Adoption of Novel Parkinson’s Technologies

Retrieved on: 
Thursday, January 11, 2024

Rune Labs , a precision neurology software and data company, today announced a strategic round of $12 million, increasing the total amount raised by the company to over $42 million.

Key Points: 
  • Rune Labs , a precision neurology software and data company, today announced a strategic round of $12 million, increasing the total amount raised by the company to over $42 million.
  • Jordi Parramon, PhD, CEO, General Partner and Co-Founder of Nexus NeuroTech Ventures and former President of Medical Devices at Verily, will join Rune Labs’ board of directors.
  • “Focused on investing in technologies that can transform how we treat brain disorders, our aim at Nexus NeuroTech Ventures is to support innovative companies like Rune Labs.
  • I strongly believe that Rune Labs and their tool, StrivePD, are set to transform how we receive care and improve outcomes for many people living with Parkinson’s,” said Benjamin Stecher, Chair of the Patient Advisory Board at Rune Labs.

AbbVie Launches PRODUODOPA® (foslevodopa/foscarbidopa) for People Living with Advanced Parkinson's Disease in the European Union

Retrieved on: 
Tuesday, January 9, 2024

NORTH CHICAGO, Ill., Jan. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson's medicinal products have not given satisfactory results.1

Key Points: 
  • The VYAFUSER™ pump for the subcutaneous delivery of PRODUODOPA received Conformité Européenne (CE) Mark in November of 2023.
  • Parkinson's disease is a chronic, progressive neurodegenerative disorder affecting approximately 6.1 million people globally3 and is expected to double by 2040.
  • "This approval is an example of our unwavering commitment to this community by developing new, transformative therapeutic options for people experiencing advanced Parkinson's disease, their families, and care partners."
  • "It is vital that the Parkinson's community have more options that can help them manage their symptoms."

Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)

Retrieved on: 
Thursday, December 7, 2023

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.
  • Carbidopa/levodopa (CD/LD), which works to control the symptoms of PD, has been the gold-standard treatment for PD since the 1970s.
  • ONGENTYS® works by inhibiting the COMT enzyme – which breaks down LD – making more LD available to reach the brain, thereby reducing “Off” time.
  • The financial terms of the agreement were not disclosed, and any incremental expenses associated with this product are contemplated within Amneal’s guidance.

Public advisory - Sabril (vigabatrin) 500 mg sachets and tablets found to contain trace amounts of another drug

Retrieved on: 
Thursday, November 9, 2023

Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing one lot of Sabril (vigabatrin) 500 mg tablets on the Canadian market found to contain trace amounts of another prescription drug, tiapride.

Key Points: 
  • Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing one lot of Sabril (vigabatrin) 500 mg tablets on the Canadian market found to contain trace amounts of another prescription drug, tiapride.
  • To help mitigate the ongoing shortage, Health Canada is working with stakeholders to monitor the supply of sachets and tablets.
  • Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing an additional lot Sabril (vigabatrin) 500 mg in sachet format on the Canadian market found to contain trace amounts of another prescription drug, tiapride.
  • Original Advisory – August 18, 2023:
    Lundbeck Canada Inc. has informed Health Canada that two lots of Sabril (vigabatrin) 500 mg powder for oral solution, in sachet format, were found to contain trace amounts of another prescription drug, tiapride.

HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals Initiate First-in-Human Phase 1 Clinical Study of HL192

Retrieved on: 
Thursday, October 12, 2023

The Phase 1 Study evaluates the safety, tolerability, and pharmacokinetics of both single and multiple doses of orally administered HL192 in healthy participants.

Key Points: 
  • The Phase 1 Study evaluates the safety, tolerability, and pharmacokinetics of both single and multiple doses of orally administered HL192 in healthy participants.
  • KS), Daewoong Pharmaceutical (KRX: 069620.KS), and NurrOn Pharmaceuticals marked a major milestone by dosing the first human healthy participant in their Phase 1 clinical trial, assessing HL192 (NurrOn designation code: ATH-399A) which is being developed for the treatment of Parkinson's disease (PD).
  • HanAll Biopharma, in collaboration with Daewoong Pharmaceutical, solidified a co-development partnership with NurrOn Pharmaceuticals to leverage the therapeutic potential of HL192 across various neurodegenerative diseases.
  • The initial results from the Phase 1 clinical trial of HL192 are expected in the second half of 2024.

BlueRock's Phase I study with bemdaneprocel in patients with Parkinson's disease meets primary endpoint

Retrieved on: 
Monday, September 18, 2023

Planning is underway for a Phase II study that is expected to begin enrolling participants in H1 (first half) 2024.

Key Points: 
  • Planning is underway for a Phase II study that is expected to begin enrolling participants in H1 (first half) 2024.
  • The data was recently presented at the International Congress of Parkinson's Disease and Movement Disorders in Copenhagen, Denmark.
  • There were two SAEs reported that were unrelated to bemdaneprocel, one seizure attributed to the surgical procedure and one COVID case.
  • Based on these results, planning is underway for a Phase II study that is expected to begin enrolling patients in H1 (first half) 2024.

BlueRock's Phase I study with bemdaneprocel in patients with Parkinson's disease meets primary endpoint

Retrieved on: 
Monday, August 28, 2023

Planning is underway for a Phase II study that is expected to begin enrolling participants in H1 (first half) 2024.

Key Points: 
  • Planning is underway for a Phase II study that is expected to begin enrolling participants in H1 (first half) 2024.
  • The data were presented at the International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.
  • There were two SAEs reported that were unrelated to bemdaneprocel, one seizure attributed to the surgical procedure and one COVID case.
  • Based on these results, planning is underway for a Phase II study that is expected to begin enrolling patients in H1 (first half) 2024.