A single arm, open label, multiple ascending dose, prospective, multicentre study to assess safety, tolerability, pharmacokinetics and pharmacodynamic of PNB028 (Test, manufactured by PNB Vesper Life Science Pvt. Ltd., India) in colon or pancreatic cancer patients.

开始日期2024-02-05

申办/合作机构

PNB Vesper Life Sciences Pvt. Ltd

CTRI/2022/10/046658 / Recruiting临床2期

A Phase II, Multicenter, Randomized, Double-blind, Placebo controlled Clinical study toevaluate efficacy and safety of PNB-001 as an adjunct to Mesalamine compared toMesalamine alone in Subjects with Inflammatory bowel disease

开始日期2022-10-28

申办/合作机构

PNB Vesper Life Sciences Pvt. Ltd

[+1]

CTRI/2021/09/036411 / Recruiting临床3期

A Phase III, Randomized, Open Label, Multicentric, Clinical Study to Evaluate the Efficacy and Safety of PNB-001 as an Adjunct to Standard of Care Compared to Standard of Care Alone in Treatment of Patients with Moderate COVID-19 Infection

开始日期2021-09-27

申办/合作机构

PNB Vesper Life Sciences Pvt. Ltd

100 项与 PNB Vesper Life Sciences Pvt. Ltd 相关的临床结果

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0 项与 PNB Vesper Life Sciences Pvt. Ltd 相关的专利（医药）

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项与 PNB Vesper Life Sciences Pvt. Ltd 相关的文献（医药）

Journal of Chemical and Pharmaceutical Sciences

Evaluation of prophylactic property of PNB001, a clinically evaluated anti-inflammatory new chemical entity in COVID-19 patients, in mice induced with lung inflammation by lipopolysaccharide

作者: Lattmann, E. ; Lattmann, P. ; Pillai, K. S. ; Balaram, P. N.

The study was conducted to evaluate prophylactic property of PNB001 (arylated 5-hydroxy-pyrrol-2-ones), a clin. evaluated anti-inflammatory and immunomodulatory new chem. entity in COVID-19 patients in Swiss albino mice.The mice were randomized into four groups (six animals/group).Group 1 which served as control received vehicle (35% polyethylene glycol (PEG) in distilled water), Group 2 received lipopolysaccharide (LPS) in saline intratracheally to induce lung inflammation (10 μg per mouse), and Group 3 received LPS as in Group 2 followed by PNB001 orally at 100 mg/kg b.w.Group 4 received daily oral administration of PNB001 at 100 mg/kg b.w. for 7 days, then lung inflammation was induced in them as in Groups 2 and 3.Myeloperoxidase (MPO) activity was determined in all groups of animals at 30 h following the induction of lung inflammation by LPS.MPO significantly increased in Group 2 compared to Group 1, and decreased significantly in Groups 3 and 4 compared to Group 2.Histopathol. examination of the lungs revealed severe infiltration of inflammatory cells in Group 2, the severity of which was to a lesser degree in Groups 3 and 4.It is concluded from the study that oral administration of PNB001 at 100 mg/kg b.w. has decreased the LPS-induced lung inflammation in mice.Daily oral administration of PNB001 at 100 mg/kg b.w. for 7 days has prophylactic action on the LPS-induced lung inflammation in mice.PNB001 has an immunomodulatory effect and may have the potential to be considered as a pre-exposure prophylaxis drug against inflammation caused by COVID-19.

medRxiv

Randomized, comparative, clinical trial to evaluate efficacy and safety of PNB001 in moderate COVID-19 patients

作者: Lattmann, Eric ; Sadasivan Pillai, K. ; Nargundkar, Neeta ; Balaram, P. N. ; Bhalerao, Pradnya ; Lattmann, Pornthip ; ShashiBhushan, B. L.

The aim was to evaluate the efficacy and safety of PNB001 a CCK-A agonist and CCK-B antagonist, a new chem. entity with anti-inflammatory and immune stimulation properties, along with Standard of Care (SOC) in patients with moderate COVID-19 infection.Multi-center, randomized, parallel group, comparative, open label study.Two tertiary-care hospitals in India.Patients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) within 2 days of randomization, having pneumonia with no signs of severe disease (severe disease means SpO2≤94% on room air), and any two of the following signs or symptoms suggestive of COVID-19: fever, cough, dyspnea, or hypoxia.Patients were randomized 1:1 to receive PNB001 at an oral dose of 100 mg three times daily for 14 days with Standard of Care (PNB001+SOC) or only SOC.The primary endpoints were mean change in the 8-point WHO Ordinal Scale score from baseline by Day 14 and mortality rate by Day 28.The key secondary endpoints were percentage of patients showing change in clin. status using the ordinal scale, improvement in inflammatory segments in X-ray chest, reduction of days of hospitalization, duration of supplemental oxygen use, days to neg. PCR for COVID-19 and change in inflammation markers Interlukin-6 (IL6) and C-reactive protein (CRP) from baseline by Day 14.A total of 40 (20 in PNB 001+SOC arm and 20 in SOC arm) patients were randomized and received treatment.The primary endpoint showed significant clin. improvement from baseline to Day 14 with PNB001+SOC (0.22 Vs 1.12; P=0.0421).One patient in PNB001+SOC arm and two patients in SOC arm died (1 Vs 2; HR: 2.0 [95%CI=0.18, 22.05]; P=0.5637) by Day 28.At the end of the treatment by Day 14, more patients achieved zero ordinal scale in PNB001+SOC arm (17 Vs 12; P=0.0766).In the PNB001+SOC arm, change in mean chest X-ray score showed significant improvement (2.05 Vs 1.16; P=0.0321), and more patients quickly showed complete improvement (10 Vs 7; HR: 1.48 [95%CI=0.64, 3.44]; P=0.4309).In the PNB001+SOC arm, patients needed shorter duration of hospitalization in days (9.45 Vs 9.80) and more patients attained earlier discharge from the hospital (19 Vs 15; P=0.0486) with respect to days.The mean duration of supplemental oxygen requirement in days was shorter (5.45 Vs 7.10) and complete withdrawal from supplemental oxygen was more frequent with PNB001+SOC compared to SOC by Day 14 (17 Vs 13; P=0.1441).All patients in both the arms had neg. PCR by the end of the study (18 Vs 17; P=0.6265) by similar time (7.6 Vs 7.0).Exploratory anal. done for IL-6, CRP, Neutrophil-Lymphocyte-Ratio (NLR), Platelet-Lymphocyte-Ratio (PLR) and Erythrocyte Sedimentation Rate (ESR) showed statistically significant reduction by Day 14 demonstrating PNB001's anti-inflammatory and immunomodulatory properties.Lymphocyte and neutrophil counts also improved by Day 14. 11 adverse events (AE) in 8 patients were observed with PNB001+SOC compared to 13 AEs in 10 patients with SOC; none of the AEs in PNB001+SOC arm were related to PNB001.The most common AE were tachycardia and acute respiratory distress syndrome; there were isolated cases of hepatic enzyme elevation and hyperglycemia.Overall, safety profile was similar between PNB001+SOC and SOC arms.PNB001 with standard of care showed significant clin. improvement in moderate COVID-19 patients when compared to standard of care and was well tolerated by moderate COVID-19 patients.

Randomized, Comparative, Clinical Trial to Evaluate Efficacy and Safety of PNB001 in Moderate COVID-19 Patients

作者: Pillai K S ; Nargundkar N ; Bl S ; Lattmann P ; Balaram P ; Lattman E ; Bhalerao P

ABSTARCTObjectiveTo evaluate the efficacy and safety of PNB001 a CCK-A agonist and CCK-B antagonist, a new chemical entity with anti-inflammatory and immune stimulation properties, along with Standard of Care (SOC) in patients with moderate COVID-19 infection.DesignMulti-center, randomized, parallel group, comparative, open label study.SettingTwo tertiary-care hospitals in India.ParticipantsPatients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) within 2 days of randomization, having pneumonia with no signs of severe disease (severe disease means SpO2≤94% on room air), and any two of the following signs or symptoms suggestive of COVID-19: fever, cough, dyspnea, or hypoxia.InterventionsPatients were randomized 1:1 to receive PNB001 at an oral dose of 100 mg three times daily for 14 days with Standard of Care (PNB001+SOC) or only SOC.Main outcome measuresThe primary endpoints were mean change in the 8-point WHO Ordinal Scale score from baseline by Day 14 and mortality rate by Day 28. The key secondary endpoints were percentage of patients showing change in clinical status using the ordinal scale, improvement in inflammatory segments in X-ray chest, reduction of days of hospitalization, duration of supplemental oxygen use, days to negative PCR for COVID-19 and change in inflammation markers Interlukin-6 (IL6) and C-reactive protein (CRP) from baseline by Day 14.ResultsA total of 40 (20 in PNB 001+SOC arm and 20 in SOC arm) patients were randomized and received treatment. The primary endpoint showed significant clinical improvement from baseline to Day 14 with PNB001+SOC (0.22 Vs 1.12; P=0.0421). One patient in PNB001+SOC arm and two patients in SOC arm died (1 Vs 2; HR: 2.0 [95%CI=0.18, 22.05]; P=0.5637) by Day 28. At the end of the treatment by Day 14, more patients achieved zero ordinal scale in PNB001+SOC arm (17 Vs 12; P=0.0766). In the PNB001+SOC arm, change in mean chest X-ray score showed significant improvement (2.05 Vs 1.16; P=0.0321), and more patients quickly showed complete improvement (10 Vs 7; HR: 1.48 [95%CI=0.64, 3.44]; P=0.4309). In the PNB001+SOC arm, patients needed shorter duration of hospitalization in days (9.45 Vs 9.80) and more patients attained earlier discharge from the hospital (19 Vs 15; P=0.0486) with respect to days. The mean duration of supplemental oxygen requirement in days was shorter (5.45 Vs 7.10) and complete withdrawal from supplemental oxygen was more frequent with PNB001+SOC compared to SOC by Day 14 (17 Vs 13; P=0.1441). All patients in both the arms had negative PCR by the end of the study (18 Vs 17; P=0.6265) by similar time (7.6 Vs 7.0). Exploratory analysis done for IL-6, CRP, Neutrophil-Lymphocyte-Ratio (NLR), Platelet-Lymphocyte-Ratio (PLR) and Erythrocyte Sedimentation Rate (ESR) showed statistically significant reduction by Day 14 demonstrating PNB001’s anti-inflammatory and immunomodulatory properties. Lymphocyte and neutrophil counts also improved by Day 14. 11 adverse events (AE) in 8 patients were observed with PNB001+SOC compared to 13 AEs in 10 patients with SOC; none of the AEs in PNB001+SOC arm were related to PNB001. The most common AE were tachycardia and acute respiratory distress syndrome; there were isolated cases of hepatic enzyme elevation and hyperglycemia. Overall, safety profile was similar between PNB001+SOC and SOC arms.ConclusionsPNB001 with standard of care showed significant clinical improvement in moderate COVID-19 patients when compared to standard of care and was well tolerated by moderate COVID-19 patients.Trial RegistrationCTRI/2020/10/028423

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