GPR37

The 2023 SITC Congress kicked off with a groundbreaking report on the latest clinical results of ENB-003, establishing a solid foundation for future research. ENB-003's R&D ProgressENB-003 is a small molecule drug developed by ENB Therapeutics, Inc. The drug targets the ETB, or endothelin B receptor, which is involved in various physiological processes. In terms of therapeutic areas, ENB-003 shows potential in treating a wide range of diseases. These include neoplasms (abnormal growth of cells), digestive system disorders, endocrinology and metabolic diseases, skin and musculoskeletal diseases, urogenital diseases, and nervous system diseases. This broad spectrum of therapeutic areas sggests that ENB-003 may have a versatile mechanism of action or multiple targets.  According to the Patsnap Synapse, ENB-003 is currently in Phase 2 of clinical trials. And the clinical trial areas for ENB-003 are primarily in the United States and Australia. The key indication is Ovarian Cancer. Detailed Clinical Result of ENB-003The non-randomized, single group assignment, open-labeled clinical trial (NCT04205227) was aimed to investigate the safety and efficacy of ENB-003 in combination with pembrolizumab in solid tumors refractory to standard of care therapies including ovarian cancer.  In this study, the Part 1 3+3 dose escalation enrolled 46 subjects and included 6 escalating doses of ENB-003 (ranging from 150ug-2000ug) in combination with a fixed dose of pembrolizumab (200mg). Pembrolizumab was administered once every 21-day cycle. ENB-003 was administered IV as a single agent during a 1-week monotherapy run-in, followed by combination therapy with pembrolizumab. ENB-003 was administered 3x per week for a total of 6 doses in odd numbered cycles for the first 5 cohorts and administered every cycle for the last and 6th cohort. The primary objective of Part 1 was to assess safety and tolerability, secondary objectives included PFS, OS and ORR by RECIST 1.1, iRECIST. Exploratory objectives are to examine biomarkers/pharmacodynamics.  The result showed that no DLTs were observed across 6 dosing cohorts. The most common treatment emergent adverse events irrespective of grade or causality included fatigue (28.2%), constipation (26.1%), abdominal pain (26.1%), nausea (23.9%), anemia 17.4%, diarrhea (17.4%). Serious adverse events, grade 3 and above considered possibly related to pembrolizumab and/or ENB-003 include fatigue (n=4), diarrhea (n=3), dyspnea (n=3) constipation (n=2), rash (n=2). The DCR across all cohorts irrespective of ETBR status was 33% (2 PR, 8 SD, 20 PD). For microsatellite stable (MSS) platinum refractory/resistant ovarian cancer (OC) there was a 40% ORR and an 80% DCR across all cohorts (2 PR, 2 SD, 1 PD) with a trend for durable responses at higher doses of ENB-003. Responses included a 95% PR of 12-month duration in a primary platinum refractory MSS OC patient. It can be concluded that MSS OC patients historically demonstrate poor response to single agent anti-PD1.ETBR blockade with ENB-003 may expand the therapeutic benefit to patients who are refractory or resistant to anti-PD1 therapy. How to Easily View the Clinical Results Using Synapse Database?If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need.  Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name.  A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more.  If you would like to view more information about this result, you can go to the result detail page by clicking on the title.  Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc.  In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data.  Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing. Click on the image below to embark on a brand new journey of drug discovery!

WILLOWBROOK, Ill., Aug. 29, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today announced the clearance of an Investigational New Drug (IND) application by the India Central Drugs Standard Control Organization (CDSCO) to conduct a Phase II clinical trial of sovateltide in hypoxic-ischemic encephalopathy (HIE) in neonates. Sovateltide is the Company’s endothelin-B receptor agonist that increases blood flow, shows anti-apoptotic activity, protects neural mitochondria, and produces neurovascular remodeling. Sovateltide is currently undergoing marketing authorization review by CDSCO to treat acute cerebral ischemic stroke. “HIE is a devastating complication of birth that can lead to serious disability or death in a significant percentage of neonates who suffer from it,” said Anil Gulati, M.D., founder, Chief Executive Officer, and Chairman of the Board of Pharmazz. “Brain damage in HIE is caused by acute hypoxia, oxidative stress, and persistent inflammation. Endothelin-B receptor agonism is neuroprotective and neurorestorative by directly addressing and countering these pathological processes. This activity has been demonstrated with sovateltide in an animal model for HIE. Improved neurological outcomes demonstrated in our pivotal trial of sovateltide in acute ischemic stroke in humans, an acute condition with underlying pathologic mechanisms similar to HIE, also suggest that it could improve the outcomes of newborns who suffer from HIE. The initiation of Phase II of this trial, which we expect to occur in October 2022, is another example of our commitment to patients in critical medical conditions.” The Phase II trial is a multicenter, randomized, double-blind, placebo-controlled study that will enroll 40 neonates with birth asphyxia to assess the efficacy and safety of sovateltide for treating HIE. Subjects will receive either three intravenous doses of sovateltide, 0.3 ug/kg on days 1, 3, and 6, or a placebo. The primary endpoint of this trial is the percentage of patients with death or moderate to severe disability, a composite measure of death or moderate/severe disability at 24 months. In addition, several secondary efficacy and safety endpoints will also be measured. More information on the clinical trial can be found at NCT05514340. About Pharmazz, Inc. Pharmazz, Inc. is a privately held company engaged in developing novel products in critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com.