niclosamide (ANA001) / Dong-A - LARVOL DELTA

Genome-wide identification, tissue expression pattern, and salt stress response analysis of the NAC gene family in Thinopyrum elongatum. (PubMed, BMC Plant Biol) - "This systematic investigation establishes a robust theoretical framework for subsequent structural and functional characterization of TeNACs in Th. elongatum."

Journal

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients (clinicaltrials.gov) - P2/3 | N=49 | Completed | Sponsor: NeuroBo Pharmaceuticals Inc. | N=120 ➔ 49

Enrollment change • Infectious Disease • Novel Coronavirus Disease

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients (clinicaltrials.gov) - P2/3 | N=120 | Completed | Sponsor: NeuroBo Pharmaceuticals Inc. | Recruiting ➔ Completed | N=436 ➔ 120

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease

A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: NeuroBo Pharmaceuticals Inc. | Recruiting ➔ Completed

Trial completion

Niclosamide in Pediatric Patients With Relapsed and Refractory AML (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Stanford University | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Niclosamide in Pediatric Patients With Relapsed and Refractory AML (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Stanford University | Initiation date: Jul 2022 ➔ Nov 2022

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Niclosamide in Pediatric Patients With Relapsed and Refractory AML (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Stanford University | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jul 2022 ➔ Jul 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients (clinicaltrials.gov) - P2/3 | N=436 | Recruiting | Sponsor: NeuroBo Pharmaceuticals Inc. | Trial completion date: Jun 2022 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Jul 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Phase 1 Study of Niclosamide in Pediatric Patients With Relapsed and Refractory AML (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Stanford University | Trial completion date: Jan 2023 ➔ Dec 2025

Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Phase 1 Study of Niclosamide in Pediatric Patients With Relapsed and Refractory AML (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Stanford University

Clinical • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers (clinicaltrials.gov) - P1; N=66; Recruiting; Sponsor: NeuroBo Pharmaceuticals Inc.; Trial completion date: Feb 2021 ➔ Oct 2021; Trial primary completion date: Feb 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients (clinicaltrials.gov) - P2/3; N=436; Recruiting; Sponsor: NeuroBo Pharmaceuticals Inc.; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

NeuroBo Pharmaceuticals Receives Approval for Amendment of Contingent Value Rights for Gemcabene (PRNewswire) - "NeuroBo Pharmaceuticals, Inc....today announced that it has received approval of an amendment to its Contingent Value Rights (CVR) agreement from a majority of the holders of a majority of the outstanding CVRs, incentivizing the evaluation of Gemcabene as a treatment for COVID-19....'We intend to evaluate Gemcabene both as a stand-alone treatment for COVID-19, and in a treatment combination with ANA001'...'We look forward to achieving multiple value-creating milestones in the coming year, including the data monitoring committee results, the pharmacokinetic (PK) data for the phase 2 trial of ANA001, the top-line data readout from the phase 2 trial of ANA001 to treat COVID-19 and preclinical in vitro data for Gemcabene against COVID-19 variants alone and in treatment combination with ANA001.'"

Licensing / partnership • P2 data • PK/PD data • Preclinical • Infectious Disease • Novel Coronavirus Disease

Form 424B3 NeuroBo Pharmaceuticals (Streetinsider.com) - "ANA-001 is currently being tested in a Phase 2/3 clinical trial....ANA-001 is a proprietary oral niclosamide formulation and was developed as a treatment for patients with moderate COVID-19....ANA-001 is currently being studied in a 60-subject Phase 2 clinical trial conducted in the United States. We plan to finalize the Phase 2 trial and to initiate the Phase 3 development program for ANA-001 in the third quarter of 2021."

Trial status • Infectious Disease • Novel Coronavirus Disease

A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers (clinicaltrials.gov) - P1; N=66; Recruiting; Sponsor: ANA Therapeutics

Clinical • New P1 trial

NeuroBo Pharmaceuticals Acquires ANA Therapeutics for Late-Stage Oral Antiviral Development Program (PRNewswire) - "NeuroBo Pharmaceuticals, Inc....today announced that on December 31, 2020 it acquired ANA Therapeutics, a privately held biotechnology company developing ANA-001, a proprietary capsule formulation of niclosamide for coronavirus indications, currently in Phase 2/3 clinical trials as a treatment for COVID-19....'Development timeline supports a number of value-creating milestones over the coming 12 to 18 months, including the data readout of the Phase 2 portion of the trial, expected in the third quarter of 2021.'"

M&A • P2 data • Infectious Disease • Novel Coronavirus Disease

ANA Therapeutics Begins Phase 2/3 Clinical Trial of Proprietary Oral Niclosamide Formulation to Treat COVID-19 (Businesswire) - "ANA Therapeutics announced today that it has begun a multicenter, Phase 2/3 clinical trial to evaluate the safety and efficacy of its proprietary, oral niclosamide (ANA001)....The Phase 2/3 trial is a randomized, placebo-controlled study that will be conducted in two parts at a total of 20 clinical sites in the U.S. In both study parts, hospitalized patients with moderate COVID-19...will be administered a seven-day course of niclosamide capsules in addition to standard of care....The trial’s second part will enroll several hundred patients..."

Trial status • Infectious Disease • Novel Coronavirus Disease

Study of Niclosamide in Moderate Hospitalized Coronavirus-19 (COVID-19) Patients (clinicaltrials.gov) - P2/3; N=436; Recruiting; Sponsor: ANA Therapeutics

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

ANA Therapeutics and Quotient Sciences Announce Partnership to Manufacture Niclosamide Drug Candidate as a Potential Treatment for COVID-19 (Businesswire) - "ANA Therapeutics...today announced a partnership to support the manufacturing of ANA Therapeutics’ drug candidate, ANA001 (niclosamide capsules), which they are developing as a potential treatment for COVID-19....Quotient will scale up the capsule formulation, characterize and optimize the manufacturing process and ensure continuity of drug product through clinical trials....ANA Therapeutics will access Quotient’s formulation and manufacturing expertise to develop and rapidly supply drug product for pivotal clinical trials in Q3 2020."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

ANA Therapeutics Announces U.S. FDA Clearance Of IND Application To Initiate Clinical Trial Of Niclosamide In COVID-19 Patients (PRNewswire) - "ANA Therapeutics...announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for ANA001 (niclosamide capsules) as a potential treatment for COVID-19....ANA Therapeutics clinical trial will seek to enroll at least 400 patients with COVID-19 at 10 centers across the U.S....and expects to enroll the first patient in August....ANA Therapeutics plans to look at niclosamide's effectiveness in treating outpatients in a later study."

IND • New trial • Trial initiation date • Infectious Disease • Novel Coronavirus Disease