ketamine/D-cycloserine/lurasidone (NRX-100/NRX-101) / NRx Pharma - LARVOL DELTA

New Pharmacologic Approaches to the Treatment of Bipolar Depression. (PubMed, Drugs) - "Included are new atypical anti-psychotics, glutamate modulators (ketamine and cycloserine/lurasidone), neurosteroid modulators (zuranolone), anti-inflammatories and mitochondrial modulators, cannabidiol (CBD) and psilocybin. New atypical anti-psychotics lumateperone and cariprazine have demonstrated efficacy in large-scale, placebo-controlled, double-blind randomized controlled trials (RCT) in treatment of BD depression...While there are potentially efficacious, mechanistically novel agents on the horizon, they require further study and validation. Further investigation on how these agents may impact specific subgroups of patients will also advance the field."

Journal • Review • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

NRx Pharmaceuticals Announces 2nd Quarter 2021 Financial Update (PRNewswire) - "'Finally, we are looking forward to restarting trials of our psychiatry drug, NRX-101, in the coming months,' said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx."

Trial status • Bipolar Disorder • CNS Disorders • Depression • Suicidal Ideation

Form 424B3 NRX Pharmaceuticals (Streetinsider.com) - P2, N=22; STABIL-B (NCT02974010); Sponsor: NeuroRx, Inc.; "Sequential treatment with ketamine/NRX-101 significantly reduced depression symptoms compared to sequential treatment with ketamine/lurasidone alone (p=.032) in a last-observation carried forward (LOCF) analysis. In a parallel MMRM analysis, a statistical difference of p=.09 was observed between groups. In addition, there were no relapses during NRX-101 treatment (0/12, 0%) vs. 2 relapses in the lurasidone alone group (2/5, 40%)....A significant between-group difference was also observed both for suicidality score (C-SSRS) (p=.02) and for clinical-rated global impression of suicidality (CGI-SS) (p=.019)....No significant treatment-related safety issues were observed in either group, and no deaths were reported in the study."

P2 data • CNS Disorders • Depression • Suicidal Ideation

NeuroRx on the Move: An Interview with Founder and CEO Jonathan Javitt (BioSpace) - "The company’s focus, as mentioned above, was on NRX-100 and NRX-101....The two drugs are used together beginning with a single infusion of ketamine followed at approximately six weeks by daily oral NRX-101. 'We hope,' Javitt said, 'they will be effective for bipolar depression, major depression disorder...especially in people who have suicidal ideation....The company initiated a Phase IIb/III trial for the drug in July 2019...'We determined that it’s not possible to meet our safety obligations to patients who have suicidal depression in the midst of a lockdown....So we suspended enrollment in the trial until the pandemic subsides a bit. We hope to be able to get to the data readout by the end of this year.'"

P2/3 data • Trial status • Bipolar Disorder • CNS Disorders • Depression • Suicidal Ideation

Big Rock Partners Acquisition Corp. Announces Merger with NeuroRx, Inc. (Streetinsider.com) - "Big Rock Partners Acquisition Corp....announces that it has entered into an Agreement and Plan of Merger with NeuroRx, Inc....The transaction is expected to occur in the first or second quarter of 2021....NeuroRx expects to have increased access to capital to continue development of its innovative drug pipeline targeting Central Nervous System (CNS)/Psychiatry and Respiratory Disease....NeuroRx's two main drugs are 'ZYESAMI' (aviptadil) which is an application for COVID-related respiratory failure and 'NRX-101', which focuses on suicidal bipolar depression and PTSD....NRX-100/101 is being developed...to treat both depression and suicidality without the hallucinations..."

Financing • M&A • Bipolar Disorder • CNS Disorders • Depression • Infectious Disease • Novel Coronavirus Disease • Post-traumatic Stress Disorder • Respiratory Diseases • Suicidal Ideation