Naltrexone hydrochloride is under clinical development by Statera Biopharma and currently in Phase I for Coronavirus Disease 2019 (COVID-19). According to GlobalData, Phase I drugs for Coronavirus Disease 2019 (COVID-19) have a 94% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Naltrexone hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Naltrexone hydrochloride overview
IRT-103 (Lodonal) is under development for the treatment of patients with pediatric and adult Crohn's disease, coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), post-acute sequelae of covid 2019 (PASC OR LONG COVID). The drug candidate is administered orally and through transdermal route. The drug candidate is a low dose naltrexone (LDN). The drug candidate targets opioid receptors. It is being developed based on AIMS: Advanced Immunomodulating Multi-receptor System platform.
It was also under development for the treatment of influenza A virus H1N1 subtype virus and HIV/AIDS,autism, ulcerative colitis, relapsing remitting multiple sclerosis, primary progressive multiple sclerosis, secondary progressive multiple sclerosis, cervical cancer and fibromyalgia.
It was under development for Multiple Sclerosis.
Statera Biopharma overview
Statera Biopharma, formerly Cytocom Inc, is a clinical-stage biopharmaceutical company that developing novel immunotherapies targeting autoimmune, neutropenia and anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. The company’s clinical program includes STAT-201, STAT-401 and STAT-205 for the treatment of crohn’s disease, hematology (entolimod), pancreatic cancer and covid-19. Statera Biopharma has a large platform of toll-like receptor (TLR) agonists with TLR4 and TLR9 antagonists and the TLR5 agonists, entolimod and GP532. The company operates in the US and Russia. Statera Biopharma is headquartered in Buffalo, New York, the US.
For a complete picture of Naltrexone hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
