niclosamide (DWRX2003) / Daewoong Pharma - LARVOL DELTA

Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients. (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Daewoong Pharmaceutical Co. LTD. | N=60 ➔ 1 | Trial completion date: Jul 2022 ➔ Dec 2022 | Not yet recruiting ➔ Terminated | Trial primary completion date: May 2022 ➔ Dec 2022; Study stopped due to difficulties in patient recruitment

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease

Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients. (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

Combination therapy • New P2 trial • Infectious Disease • Novel Coronavirus Disease

To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers. (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Daewoong Pharmaceutical Co. LTD.; Recruiting ➔ Completed; Trial completion date: Nov 2021 ➔ Jun 2021

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

To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers. (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Daewoong Pharmaceutical Co. LTD.; Trial completion date: Jun 2021 ➔ Nov 2021; Trial primary completion date: Mar 2021 ➔ Jul 2021

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

To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines) (clinicaltrials.gov) - P1; N=2; Terminated; Sponsor: Daewoong Pharmaceutical Co. LTD.; N=40 ➔ 2; Not yet recruiting ➔ Terminated; Trial primary completion date: Oct 2020 ➔ Mar 2021; Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.

Enrollment change • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • PCR

Daewoong, Q1 is just early stage of better performance (PRNewswire.co.uk) - "Daewoong Pharmaceutical(CEO Sengho Jeon) announced its management performance (based on consolidation) in Q1 of 2021....'Foistar Tab and DWRX2003(Niclosamide) for COVID19 treatmenmt...are also considered to have great market potential' he said."

Commercial • Infectious Disease • Novel Coronavirus Disease

PT. Daewoong Infion from Korea Receives Government Permit to Conduct Clinical Trials for COVID-19 Treatment [Google translation] (Industry Coid) - "Daewoong Pharmaceutical Korea and PT. Daewoong Infion...has signed an MoU on Clinical Trial of COVID-19 treatment with the Indonesian Ministry of Health...Based on the MOU, PT. Daewoong Infion will conduct a clinical trial of casmostat and niclosamide on COVID-19 patients in Indonesia....Daewoong Pharmaceutical Korea is currently undergoing phase I clinical trials of niclosamide in Korea, Australia and India, and plans to announce the results of its Phase II clinical trials conducted in various countries in the first half of 2021....Last year, PT. Daewoong Infion has signed an MoU with the Ministry of Health of the Republic of Indonesia to conduct a clinical trial of stem cell-based COVID-19 treatment (DWP710)...The company is preparing to apply for a license to carry out phase II clinical trials in Korea after completing phase I clinical trials in Indonesia."

Cytokine storm • New P2 trial • P2 data • Infectious Disease • Novel Coronavirus Disease

To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers. (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Daewoong Pharmaceutical Co. LTD.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Daewoong’s Covid-19 treatment candidate to get state subsidy (Korea Biomedical Review) - "...DWRX2003 (niclosamide), a Covid-19 treatment candidate, has been selected as a state-supported project in building production facilities. The company will receive 1.9 billion won ($1.7 million) from the Ministry of Health and Welfare....Within the first half-year, it aims to secure the results of the multinational P2 trial of mild to moderate patients and receive the conditional permit and emergency use authorization from home and abroad."

Cytokine storm • Financing • Non-US regulatory • P2 data • Infectious Disease • Novel Coronavirus Disease

South Korea Daewoong Pharma eyes Phase II trials of coronavirus drug, shares jump (Reuters) - "South Korean drugmaker Daewoong Pharma said on Thursday it had sought regulatory approval for Phase II trials of its anti-parasite niclosamide drug to treat COVID-19 patients, sending its shares up nearly 6%. Daewoong Pharma, which has sought permission from South Korea’s food and drug safety ministry to hold Phase II clinical trials of its coronavirus drug DWRX2003, said 200 infected patients would participate....The company said its anti-parasite nicholasmide drug DWRX2003 does not need to be refrigerated..."

New P2 trial • Non-US regulatory • Novel Coronavirus Disease

Daewoong Pharmaceutical and Tufts Medical Center join on phase 2 clinical trials of Niclosamide for COVID19 (PRNewswire) - "Entering phase 2 clinical trial in the United States based on trial results in South Korea, India, and Australia; Collaboration with Dr. Harry Selker of Tufts Medical Center and the Tufts Niclosamide Team...is expected to bring great synergy; A clinical trial is now underway at Tufts Medical Center....Daewoong Pharmaceutical is planning a pre-IND meeting with the U.S. FDA to apply for a phase 2 clinical trial..."

FDA event • Licensing / partnership • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Daewoong Pharmaceutical’s Long-Acting Niclosamide Shows High Promise Against Upcoming COVID-19 ’Twindemic’ (PRNewswire) - P1, N=31; NCT04524052; Sponsor: Daewoong Pharmaceutical Co. LTD.; "Covid-19 treatment candidate of sustained-release niclosamide (DWRX2003) also showed promising study results for a fight against the upcoming 'Twindemic' involving COVID-19 and seasonal flu....Niclosamide successfully reduced the IVA-driven mortality rate in an animal efficacy test....The first cohort of healthy individuals in India confirmed the low-dose safety of DWRX2003 and has allowed further trial progression....Approval to initiate phase 1 clinical trials in Australia allowed Daewoong to start collecting Caucasian-based clinical data. Daewoong plans to enter subsequent multinational clinical trials within this year based on phase 1 clinical results..."

P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease

To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003 (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Daewoong Pharmaceutical Co. LTD.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines) (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Daewoong Pharmaceutical Co. LTD.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19 (clinicaltrials.gov) - P1; N=32; Not yet recruiting; Sponsor: Daewoong Pharmaceutical Co. LTD.

New P1 trial • Infectious Disease • Novel Coronavirus Disease

S. Korea’s Daewoong Pharma gets India nod to test anti-parasite drug for COVID-19 (The Jakarta Post) - "The phase 1 trial, approved by India's Central Drugs Standard Control Organization (CDSCO), will involve around 30 healthy participants to test safety and kickstart this month....The South Korean drugmaker is testing the drug in partnership with New Delhi-based Mankind Pharma Ltd, which will continue the second and third phases of trials in India....The trial results from India will be used for export permits in Europe and the United States....The company is also waiting for a separate phase 1 trial approval from South Korea....Its anti-viral drug had completely eliminated the novel coronavirus from animals' lungs during pre-clinical testing."

Licensing / partnership • New P1 trial • Preclinical • Infectious Disease • Novel Coronavirus Disease

Daewoong Pharmaceutical Redoubling Efforts for COVID-19 Drug Development (Business Korea) - "Daewoong Pharmaceutical submitted an investigational new drug (IND) application in the Philippines on July 3 regarding DWRX2003 for COVID-19 drug development....Virus removal from the lung tissue led to suppressed inflammatory cytokine secretion and inflammation prevention in the tissue....Its second- and third-phase trials will be conducted on a large scale so that the drug can be quickly supplied to Southeast Asian countries....Its clinical trial plan is expected to be approved in July. Then, the outcome of its trials will be utilized as data for approvals in the United States and Europe."

New trial • Non-US regulatory • Infectious Disease • Novel Coronavirus Disease