GPP-Baladol (PNB-001) / PNB Vesper Life Science - LARVOL DELTA

DCGI allows PNB Vesper Life Science to conduct phase-III clinical trials on PNB 001/GPP-BALACOVIN to treat COVID-19 (ExpressPharma) - "PNB Vesper has received permission from the Drugs Controller General of India (DCGI) to enter into the phase-III clinical trials of PNB 001/GPP-BALACOVIN...After a detailed deliberation by the Subject Expert Committee (SEC) on the phase-II clinical trial results of PNB – 001 (GPP-BALACOVIN), the company has now been given a green signal to conduct a nation-wide multi-centered phase-III clinical trial on hospitalised COVID-19 patients with oxygen support. The phase-III trial will be conducted on a large patient population in 12 hospitals all over India."

New P3 trial • Infectious Disease • Novel Coronavirus Disease

Kerala firm approaches DCGI for emergency use authorisation of Covid drug (Daijiworld) - "PNB Vesper...announced on Tuesday that it has approached the Drugs Controller General of India (DCGI) and the government of India for an emergency use authorisation of its new drug to treat hospitalised Covid patients. The company announced that it has successfully completed the Phase 2 clinical trials of its drug and submitted the final report of its proprietary drug PNB-001 (GPP-Baladol) to the DCGI."

Non-US regulatory • Infectious Disease • Novel Coronavirus Disease

PNB Vesper initiates Ph 2 trials of NCE PNB-001 for COVID-19 treatment (BioSpectrum India) - "PNB Vesper in Kochi...to conduct Covid-19 Phase 2 Clinical trials of their NEW CHEMICAL ENTITY PNB-001 (GPP-Baladol®), has been given the ethical committee approval to go ahead....The first patient, having COVID-19 pneumonia and breathing problems has been administered GPP-Baladol....The study will be completed in 60 days. The interim efficacy results will be released within 30 days. The effect of PNB 001 will be compared with Dexamethasone, currently the most used medication for COVID-19 treatment."

Cytokine storm • P2 data • Trial status • Infectious Disease • Novel Coronavirus Disease

PNB Vesper gets nod to begin phase-2 clinical trials for COVID-19 drug (The Economic Times) - "...PNB Vesper has secured the drug controller's permission to launch phase-II clinical trials for a potential COVID-19 drug -- making it the first in the world to begin such trials for a new chemical entity....The trials will be conducted on 40 COVID-19 positive patients at the BMJ Medical College, Pune....Based on the outcome of the phase-I trials, he said the PNB001 is 20 times more efficient than aspirin and has not shown any toxic reaction on the patients. If the second phase is successful, the company will go for the third phase trials on 378 patients in AIIMS New Delhi..."

New molecule • New P2 trial • Infectious Disease • Novel Coronavirus Disease