Pleo Pharma
PleoPharma is a pharmaceutical company dedicated to developing therapies for unmet medical needs in the CNS and substance abuse space, particularly focusing on cannabis-related health issues. Their mission is to provide safe and effective treatments for conditions like Cannabis Use Disorder and Cannabis Withdrawal Syndrome, which currently lack FDA-approved solutions. The company is advancing a lead program, PP-01, which has completed Phase 2 and is progressing towards Phase 3, with a focus on mitigating cannabis withdrawal symptoms and related sleep disturbances. PleoPharma emphasizes high standards of ethics and aims to be a first-in-class treatment provider.
Industries
Nr. of Employees
small (1-50)
Pleo Pharma
Products
Investigational oral dual-mechanism therapeutic for mitigation of cannabis withdrawal
A once-daily oral investigational medicine in development to mitigate cannabis withdrawal symptoms in people with cannabis use disorder; dual mechanism targets suppressed CB1 receptor activity and neurotransmitter dysregulation in the mesolimbic reward pathway. Clinical development completed through Phase 2b with Phase 3 preparations underway.
Investigational oral dual-mechanism therapeutic for mitigation of cannabis withdrawal
A once-daily oral investigational medicine in development to mitigate cannabis withdrawal symptoms in people with cannabis use disorder; dual mechanism targets suppressed CB1 receptor activity and neurotransmitter dysregulation in the mesolimbic reward pathway. Clinical development completed through Phase 2b with Phase 3 preparations underway.
Services
Clinical development and trial management
Management of multicenter clinical studies including protocol design, site coordination, data collection, safety monitoring and statistical analysis for addiction therapeutics.
Regulatory strategy and FDA engagement support
Support for regulatory interactions including preparation for End-of-Phase-2 meetings and pursuit of expedited designations to facilitate development timelines.
Expanded access and compassionate use evaluation
Case-by-case review and management of expanded access requests in line with regulatory guidance and ethical requirements; physician-initiated application process described.
Business development and investor relations
Engagement with potential partners and investors to support clinical development and commercialization efforts; experience raising Series A financing.
Clinical development and trial management
Management of multicenter clinical studies including protocol design, site coordination, data collection, safety monitoring and statistical analysis for addiction therapeutics.
Regulatory strategy and FDA engagement support
Support for regulatory interactions including preparation for End-of-Phase-2 meetings and pursuit of expedited designations to facilitate development timelines.
Expanded access and compassionate use evaluation
Case-by-case review and management of expanded access requests in line with regulatory guidance and ethical requirements; physician-initiated application process described.
Business development and investor relations
Engagement with potential partners and investors to support clinical development and commercialization efforts; experience raising Series A financing.
Expertise Areas
- Clinical trial management
- Clinical pharmacology (PK/PD)
- Addiction therapeutics development
- Regulatory strategy and FDA interactions
Key Technologies
- Randomized double-blind placebo-controlled trial methodologies
- Pharmacokinetic and pharmacodynamic studies
- Oral small-molecule formulation and dosing schedules
- Dual-mechanism pharmacology targeting CB1 receptor pathways and neurotransmitter modulation