CNP-201 / Cour Pharma - LARVOL DELTA

CNP-201 in Subjects With Peanut Allergy (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: COUR Pharmaceutical Development Company, Inc. | Phase classification: P1b/2a ➔ P1 | N=58 ➔ 15 | Trial completion date: Dec 2024 ➔ Dec 2023 | Recruiting ➔ Terminated | Trial primary completion date: May 2024 ➔ Dec 2023; Lagging Enrollment and Administrative Reasons

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Trial termination • Allergy • Food Hypersensitivity • Immunology • CCL4 • CXCL8 • IFNG • IL1B • IL2 • IL6 • TNFA

Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: COUR Pharmaceutical Development Company, Inc. | Phase classification: P1/2 ➔ P1

Phase classification • Allergy • Food Hypersensitivity • Immunology • CXCL8 • IL2 • IL5 • IL6

CNP-201 in Subjects With Peanut Allergy (clinicaltrials.gov) - P1b/2a | N=58 | Recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: May 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology • CD4 • CXCL8 • IL2 • IL6

CNP-201 in Subjects With Peanut Allergy (clinicaltrials.gov) - P1b/2a | N=58 | Recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc. | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology • CD4 • CXCL8 • IL2 • IL6

Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy (clinicaltrials.gov) - P1/2 | N=3 | Terminated | Sponsor: COUR Pharmaceutical Development Company, Inc. | N=48 ➔ 3 | Trial completion date: Apr 2023 ➔ Jun 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Jun 2022; Lagging Enrollment. Opened a separate study.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Allergy • Food Hypersensitivity • Immunology • CCL4 • CXCL8 • IFNG • IL1B • IL2 • IL5 • IL6 • TNFA

CNP-201 in Subjects With Peanut Allergy (clinicaltrials.gov) - P1b/2a | N=58 | Recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc. | N=18 ➔ 58

Enrollment change • Allergy • Food Hypersensitivity • Immunology • CCL4 • CD4 • CXCL8 • IFNG • IL1B • IL2 • IL6 • TNFA

CNP-201 in Subjects With Peanut Allergy (clinicaltrials.gov) - P1b/2a | N=18 | Recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Allergy • Food Hypersensitivity • Immunology • CCL4 • CXCL8 • IFNG • IL1B • IL2 • IL6 • TNFA

SAGE-718 in Parkinson's Disease Mild Cognitive Impairment: Results from the Phase 2 PARADIGM Study (Part A) (AAN 2022) - P2 | "Objective: The ongoing Phase 2, open-label, PARADIGM Study (NCT04476017; 718-CNP-201) is evaluating SAGE-718 3 mg once daily in participants with mild cognitive impairment due to Parkinson’s disease (PD-MCI). These data support the emerging clinical profile of SAGE-718 in PD-MCI, suggesting improved performance on executive functioning, as well as promising signals on learning and memory. A 4-week dosing cohort (Part B) is ongoing."

P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders • Huntington's Disease • Movement Disorders • Pain • Parkinson's Disease

SAGE-718 IN PARKINSON'S DISEASE MILD COGNITIVE IMPAIRMENT: RESULTS FROM THE PHASE 2 PARADIGM STUDY (PART A) (ADPD 2022) - P2 | "Aims: The ongoing Phase 2, open-label, PARADIGM Study (NCT04476017; 718-CNP-201) evaluates SAGE-718 3mg once-daily in participants with mild cognitive impairment due to Parkinson’s Disease (PD- MCI). These data support the emerging clinical profile of SAGE-718 in PD-MCI, suggesting improved performance on executive functioning, as well as promising signals on learning and memory. A 4-week dosing cohort is ongoing."

P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease

Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-55 With Peanut Allergy (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc. | Trial completion date: Oct 2022 ➔ Apr 2023 | Trial primary completion date: Jun 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology • CCL4 • CXCL8 • IFNG • IL1B • IL2 • IL5 • IL6 • TNFA

COUR Pharmaceuticals Announces First in Human Dosing in Proof-of-Concept Trial of CNP-201 to Treat Peanut Allergy (PRNewswire) - "COUR Pharmaceuticals...announced that the first patient has been dosed in the Company's first-in-human proof-of-concept (Phase 1b/2a) of its lead candidate, CNP-201, for the treatment of peanut allergy. The trial will evaluate the safety and efficacy of CNP-201 in people ages 16 to 55 with peanut allergy..."

Trial status • Food Hypersensitivity

FDA Accepts Investigational New Drug Application for Peanut Allergy Candidate Developed by COUR Pharmaceuticals (PRNewswire) - "COUR Pharmaceuticals...announced the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for evaluation of COUR's CNP-201 in a proof-of-concept (Phase 1 / 2) study in people who are allergic to peanuts....'This will be the first clinical trial with a first-in-class therapy to re-program the immune system to stop the allergic response to peanuts,'...will evaluate the safety and potential efficacy of CNP-201 in people ages 16 to 55 with peanut allergy."

IND • Food Hypersensitivity

Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-55 With Peanut Allergy (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: COUR Pharmaceutical Development Company, Inc.

New P1/2 trial • Allergy • Food Hypersensitivity • Immunology • CXCL8 • IFNG • IL1B • IL2 • IL5 • IL6 • TNFA