Falkieri (esketamine inhalation) / Celon Pharma - LARVOL DELTA

Esketamine inhaled as dry powder: Pharmacokinetic, pharmacodynamic and safety assessment in a preclinical study. (PubMed, Pulm Pharmacol Ther) - "The pharmacological safety studies confirmed that the observed effects were transient and that inhaled esketamine had a good safety profile. Hence, our preclinical studies demonstrated that dry powder inhalation is a highly efficacious and safe delivery route for esketamine and may be a viable alternative administration route meriting further clinical development."

Journal • PK/PD data • Preclinical • CNS Disorders • Depression • Psychiatry

Current report 27/2021 - Phase 2 clinical trial status update of Esketamine-based drug in patients with bipolar depression [Google translation] (Celon Pharma Press Release) - P2, N=88; "...the Company received an update on the course and results of the study from an established organization dealing with the organization and monitoring of the study, including a 6-week follow-up....In the opinion of the Management Board of the Company, the current data confirm the high effectiveness of the drug, also in terms of the long-term effect, its good tolerance, and constitute a strong basis for the continuation of development in the next clinical phase 3 trials. Details of the study will be published and presented at upcoming medical conferences."

P2 data • CNS Disorders • Depression

Falkieri: Initiation of P3 trial for treatment-resistant depression in Q4 2021 (Celon Pharma) - Corporate Presentation

New P3 trial • Depression

Celon Pharma Hosting a Virtual Capital Markets Day on Wednesday, April 21st (GlobeNewswire) - "Celon Pharma S.A. today announced that it will host a virtual Capital Markets Day to be held on Wednesday, April 21, 2021 at 10:00 AM ET. The webinar will feature a discussion hosted by Key Opinion Leader Dr. Piotr Wierzbiński and fellow scientists - Prof. Joanna Chorostowska-Wynimko, Instytut Gruzlicy i Chorob, and Prof. Eduard Vieta, University of Barcelona, covering leading pipeline assets such as esketamine in bipolar depression, and other programs in solid tumors and inflammatory disease."

Review • CNS Disorders • Depression • Major Depressive Disorder

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression (clinicaltrials.gov) - P2; N=88; Completed; Sponsor: Celon Pharma SA; Active, not recruiting ➔ Completed

Clinical • Trial completion • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression (clinicaltrials.gov) - P2; N=88; Active, not recruiting; Sponsor: Celon Pharma SA; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Celon Pharma Announces Positive Falkieri Phase II Results in Treatment-Resistant Bipolar Depression (GlobeNewswire) - P2, N=88; NCT03965871; Sponsor: Celon Pharma SA; "Celon Pharma...today announced positive top-line results from a Phase II study of Falkieri (proprietary esketamine dry powder inhalation) in acute phase of treatment-resistant bipolar depression. In the trial, Falkieri met the primary endpoint with statistically significant reductions in MADRS total score...'We look forward to meeting with the U.S. Food and Drug Administration and European Medicines Agency to discuss initiating a Phase 3 program in 2021 and in parallel to actively seek partners to commercialize this exciting product.'...Full data from the Phase 2 trial will be presented at an upcoming medical conference....Celon Pharma will discuss top-line results from its Phase 2 trial of Falkieri for adjunctive treatment of patients with treatment resistant bipolar depression via videoconference call on Jan 11, 9.00 CET time."

New P3 trial • P2 data • CNS Disorders • Depression

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Celon Pharma SA; Trial completion date: Apr 2020 ➔ Dec 2020; Trial primary completion date: Feb 2020 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression (clinicaltrials.gov) - P2; N=88; Completed; Sponsor: Celon Pharma SA; Active, not recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression (clinicaltrials.gov) - P2; N=88; Active, not recruiting; Sponsor: Celon Pharma SA; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Celon Pharma completes interim analysis of stage II of clinical test of esketamine-based drug (Reuters) - "Celon Pharma SA: COMPLETES INTERIM ANALYSIS OF STAGE II OF CLINICAL TEST OF DRUG BASED ON ESKETAMINE; INITIAL RESULTS OF PHASE II SHOW EFFECTIVENESS OF MEDICINE AND ITS GOOD TOLERANCE' TEST RESULTS QUALIFY DRUG FOR FURTHER DEVELOPMENT ON LARGER POPULATIONS. "

P2 data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Celon Pharma SA; Trial primary completion date: Nov 2019 ➔ Feb 2020

Clinical • Trial primary completion date

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Celon Pharma SA; Trial completion date: Nov 2019 ➔ Apr 2020; Trial primary completion date: Sep 2019 ➔ Feb 2020

Clinical • Trial completion date • Trial primary completion date

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Celon Pharma SA; Trial completion date: Oct 2019 ➔ Jan 2020; Trial primary completion date: Aug 2019 ➔ Nov 2019

Clinical • Trial completion date • Trial primary completion date

Safety and pharmacokinetic study of inhaled Esketamine after a multiple dose in healthy volunteers (ECNP 2019) - "Background:Ketamine is a medicine used for over 50 years in human and veterinary anaesthesia and analgesia. Inhaled Esketamine was safe and well tolerated. Pharmacokinetic profile of inhaled Esketamine supports dry powder inhalation as a convenient delivery route. The obtained results suggest low intrasubject variability and justify further development of the therapy for patients suffering from TRD."

Clinical • PK/PD data

Safety assessment of esketamine administered via dry powder inhalation in animals and humans during preclinical toxicology and phase I clinical study (Neuroscience 2019) - "Despite ketamine has been used as a medicine for over 50 years, there are only single reports on the safety of ketamine in animals and humans, in particular for other than parental administration routes. No abnormalities in laboratory tests or ECG were observed. The presented studies confirm that esketamine administered via dry powder inhalation is well tolerated and safe at doses intended to be used for efficacy studies in treatment-resistant and bipolar depression."

P1 data

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Celon Pharma SA

Clinical • New P2 trial

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Celon Pharma SA

Clinical • New P2 trial