Like many aspects of healthcare business space, drug development is in a state of constant change for the purpose of better health outcomes. Here is a summarised report of new drug therapies currently in clinical trials worldwide as from this week.
|Sponsor||Study Phase||Drug Name/Code||Clinical Indication||Status||Comment|
|Verseon||Phase I||VE-1902||Coronary Artery Disease||This is a single centre Phase I clinical trial, double-blinded, randomized, placebo-controlled in study design, will investigate the tolerability, and composite haemostatic profile of VE-1902. Another aspect of the study design is its single daily oral dosing in two stages. The first will be a single ascending dose stage with a food effect cohort while the other will be a multiple ascending dose stage with seven-day repeat dosing.||This Phase I study will evaluate safety, pharmacokinetics, and pharmacodynamics of VE-1902 in 100 to 120 healthy volunteers. This decoagulant candidate is the first PRrecision Oral AntiCoagulant (PROAC) of a US-based pharma company to enter into clinical development. Secondary endpoints of the study will investigate VE-1902’s pharmacokinetic and pharmacodynamic profiles.|
|Actinium Pharmaceuticals, Inc.||Phase I/II||Actimab-A and Venetoclax||Acute Myeloid Leukemia (AML)||This Phase I/II combination study will enroll patients with relapsed or refractory AML or Acute Myeloid Leukaemia that have been previously treated with Venetoclax as well as patients that have never received venetoclax.||Venetoclax is a BCL-2 or B-Cell Lymphoma 2 inhibitor that is jointly developed and marketed by AbbVie (ABBV) and Genentech. The sponsor postulates that the targeted radiation from Actimab-A can more effectively deplete MCL-1 levels thereby removing the AML cells' resistance mechanism and rendering them more susceptible to Venetoclax.|
|Orphan Technologies||Phase I/II||OT-58||Cystathionine Beta-Synthase (CBS) Deficient Homocystinuria/Classical Homocystinuria||This is a double-blinded, randomized, placebo-controlled, Phase I/II study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical effects of OT-58 in patients with Cystathionine Beta-Synthase (CBS) Deficient Homocystinuria. This clinical trial will enroll up to 20 patients. The primary endpoint of the Phase I portion of the study is safety.||OT-58 is a modified recombinant enzyme therapy undergoing development for patients afflicated by the rare disease Classical Homocystinuria. OT-58 is designed to help patients reduce their homocysteine levels and restore a normal lifestyle. Secondary endpoints of this study include evaluation of pharmacokinetic and pharmacodynamic parameters.|
|Neurana Pharmaceuticals||Phase II||Tolperisone||Acute Muscle Spasms of the Back||This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of Tolperisone or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm. The primary endpoint is subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain). This Phase II trial will be conducted across approximately 45 sites in the US.||Tolperisone is proposed to exhibit effective analgesic activity in addition to muscle relaxation because of its centrally-acting dual voltage gated calcium and sodium channel blocker mechanism of action.|
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