Psychiatry/Psychology | Phase I Developments

LB Pharmaceuticals

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United Kingdom

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LB Pharmaceuticals Inc Announces Results of LB-102 Phase 1 First-in-Human Clinical Study

Lead Product(s): Amisulpride

Therapeutic Area: Psychiatry/Psychology Product Name: LB-102

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 14, 2020

Details:

LB-102 was well-tolerated up to 150 mg/day. Plasma concentrations of LB-102 were ~2.5 times greater than published values of amisulpride at the same dose, suggesting LB-102 could be dosed substantially lower than amisulpride.

Click Therapeutics

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United States

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Boehringer Ingelheim and Click Therapeutics Enter into Collaboration to Develop and Commercialize CT-155

Lead Product(s): CT-155

Therapeutic Area: Psychiatry/Psychology Product Name: CT-155

Highest Development Status: Phase I Product Type: Undisclosed

Partner/Sponsor/Collaborator: Boehringer Ingelheim

Deal Size: $500.0 million Upfront Cash: Undisclosed

Deal Type: Collaboration September 11, 2020

Details:

Under the terms of the partnership agreement, Click Therapeutics will be primarily responsible for research and development activities, and will support Boehringer Ingelheim as it undertakes worldwide commercialization activities.

Tonix Pharmaceuticals Holding Corp

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Tonix Pharmaceuticals Announces Clearance of IND for TNX-102 SL for Treatment of Alcohol Use Disorder

Lead Product(s): Cyclobenzaprine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102 SL

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 06, 2020

Details:

FDA has cleared the Investigational New Drug (IND) application for the initiation of a Phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder (AUD).

Cerevel Therapeutics

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Cerevel to Raise $445M in Merger with Blank-Check Company

Lead Product(s): CVL-231

Therapeutic Area: Psychiatry/Psychology Product Name: CVL-231

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: PIPE

Deal Size: $445.0 million Upfront Cash: Undisclosed

Deal Type: Financing July 30, 2020

Details:

Upon completion of the business combination, the net proceeds will be used to advance development of Cerevel Therapeutics’ diverse neuroscience pipeline, including potential treatments for schizophrenia, epilepsy, and Parkinson’s diseas.

Astellas Pharma

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JAPAN Japan

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Astellas is Awarded Grant from the U.S. National Institutes of Health (NIH) to Fund Early Clinical Studies of ASP8062

Lead Product(s): ASP8062

Therapeutic Area: Psychiatry/Psychology Product Name: ASP8062

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: National Institutes of Health

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Funding July 22, 2020

Details:

This NIH grant will help fund Astellas's two phase 1 clinical studies to evaluate the safety and efficacy of ASP8062, an oral small molecule GABAB receptor Positive Allosteric Modulator (PAM), as an add-on maintenance therapy for Opioid Use Disorder (OUD).

Orexo

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SWEDEN Sweden

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Positive Results from Human PK Study Assessing Orexo's Intranasal Nalmefene Formulations for Opioid Overdose Reversal

Lead Product(s): Nalmefene

Therapeutic Area: Psychiatry/Psychology Product Name: OX125

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

Details:

The study was a cross-over, comparative bioavailability study in healthy volunteers to assess nalmefene absorption from three development formulations of OX125, Orexo's wholly-owned nasal nalmefene product, compared to a nalmefene intramuscular injection.

Impel NeuroPharma

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Impel NeuroPharma Announces Publication of Positive Results of SNAP 101 Study for INP105

Lead Product(s): Olanzapine

Therapeutic Area: Psychiatry/Psychology Product Name: INP105

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

Details:

Study shows INP105 achieves rapid absorption which may provide an effective, convenient, & noninvasive future alternative for treating acute agitation in the home, community, or hospital setting.

Seelos Therapeutics

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Seelos Therapeutics Announces Final Data from Phase I PK/PD Study of Intranasal Racemic Ketamine (SLS-002) and Clinical Development Plans

Lead Product(s): Ketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: SLS-002

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 23, 2020

Details:

SLS-002 Was Safe and Well Tolerated Across All Doses with Resolution of Expected Group Mean Dissociative Side-Effects That Occurred in the Higher Dose Groups Within One Hour.

Lyndra Therapeutics

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United States

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Lyndra Therapeutics Achieves Critical Milestones Despite COVID-19 Headwinds

Lead Product(s): Risperidone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 10, 2020

Details:

Lyndra Therapeutics completed enrollment and dosing of its Phase I clinical trial for an ultra-long-acting oral risperidone therapy to treat schizophrenia, ramping up manufacturing capabilities and growing its employee base by 28%.

Neurana Pharmaceuticals

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Neurana Pharmaceuticals Announces Publication of a Driving Study Demonstrating the Effects of Tolperisone

Lead Product(s): Tolperisone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 12, 2020

Details:

The publication reports results from the Phase 1, threeway, randomized, blinded, three-period crossover study that evaluated cyclobenzaprine in neuromuscular conditions.

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Phase I

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Companies

LB Pharmaceuticals

LB Pharmaceuticals Inc Announces Results of LB-102 Phase 1 First-in-Human Clinical Study

Click Therapeutics

Boehringer Ingelheim and Click Therapeutics Enter into Collaboration to Develop and Commercialize CT-155

Tonix Pharmaceuticals Holding Corp

Tonix Pharmaceuticals Announces Clearance of IND for TNX-102 SL for Treatment of Alcohol Use Disorder

Cerevel Therapeutics

Cerevel to Raise $445M in Merger with Blank-Check Company

Astellas Pharma

Astellas is Awarded Grant from the U.S. National Institutes of Health (NIH) to Fund Early Clinical Studies of ASP8062

Orexo

Positive Results from Human PK Study Assessing Orexo's Intranasal Nalmefene Formulations for Opioid Overdose Reversal

Impel NeuroPharma

Impel NeuroPharma Announces Publication of Positive Results of SNAP 101 Study for INP105

Seelos Therapeutics

Seelos Therapeutics Announces Final Data from Phase I PK/PD Study of Intranasal Racemic Ketamine (SLS-002) and Clinical Development Plans

Lyndra Therapeutics

Lyndra Therapeutics Achieves Critical Milestones Despite COVID-19 Headwinds

Neurana Pharmaceuticals

Neurana Pharmaceuticals Announces Publication of a Driving Study Demonstrating the Effects of Tolperisone