This week on Pipeline Moves, we kick off by looking at a Phase II trial of Noema Pharma’s NOE-105 in stuttering which completed.
Meanwhile, Lyvgen Biopharma terminated a trial of its pipeline candidate exlinkibart in prostate cancer.
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On a positive note, Ability Pharmaceuticals’s pancreatic ductal adenocarcinoma trial, Levation Pharma’s ptosis trial and Stcube’s ovarian cancer trial have all completed.
Interested in more news in your inbox? Sign-up for our daily newsletter.Phase IIb stammering trial completes
Noema Pharma’s NOE-105 saw its Phase Transition Success Rate (PTSR), increase after a Phase IIb trial was completed. The drug candidate’s PTSR increased by nine points in stuttering or stammering, reaching 56%. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
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The Phase IIb trial’s (NCT05583955) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 13 March and GlobalData evaluated the asset on the following day.
The purpose of the multi-centre, double-blind, placebo-controlled study was to evaluate the safety and efficacy of NOE-105 in adult male patients with childhood-onset fluency disorder or stuttering. The study enrolled 75 patients.
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By GlobalDataNOE-105 acts as a phosphodiesterase 10A (PDE10A) inhibitor. The Basel, Switzerland-based company is developing the drug candidate for the treatment of Tourette syndrome and childhood-onset fluency disorder.
Phase II pancreatic ductal adenocarcinoma trial completes
Ability Pharmaceuticals’s ABTL-0812 saw a seven-point rise in its PTSR settling at 41% in pancreatic ductal adenocarcinoma, following a Phase II trial completion.
The study’s (NCT04431258) ClinicalTrials.gov status changed from recruiting to completed on 15 March, and the PTSR change was recorded on 19 March.
The Phase II trial investigated the safety and efficacy of ABTL-0812 in combination with FOLFIRINOX chemotherapy for the first-line treatment of metastatic pancreatic cancer. The study assessed the recommended dose and progression-free survival as its primary endpoints.
ABTL-0812 acts by inhibiting protein synthesis and cell survival pathways and blocking DNA synthesis, leading to tumour cell death. Barcelona, Spain-based Ability is also investigating the small molecule for its potential in lung cancer and endometrial cancer.
Phase I/II ptosis trial completes
Levation Pharma’s oxymetazoline saw its PTSR in ptosis increase after a Phase I/II trial was completed. The drug candidate’s PTSR increased by nine points in ptosis, reaching 18%.
The Phase I/II trial’s (NCT05715346) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 13 March and GlobalData evaluated the asset the following day.
The purpose of the multi-centre, randomised, vehicle-controlled, double-masked study was to evaluate oxymetazoline in subjects with acquired blepharoptosis. The study enrolled 33 patients.
Oxymetazoline act as alpha-adrenergic agonist. The Tel-Aviv, Israel-based company is developing the drug candidate for the treatment of acquired blepharoptosis or ptosis.
Phase I ovarian cancer completed
Stcube’s nelmastobart saw its PTSR increase after a Phase I trial was completed. The monoclonal antibody’s (mAb) PTSR increased by six points in ovarian cancer, reaching 59%.
The Phase I trial’s (NCT05231746) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 13 March, and GlobalData evaluated the asset on the following day.
The purpose of the multi-centre, open-label study was to investigate the safety, tolerability, and pharmacokinetics of nelmastobart in subjects with solid tumours. The study enrolled 47 patients.
Nelmastobart acts by inhibiting BTN1A1. The mAb is under development for the treatment of various cancers.
Phase I prostate cancer terminated
Lyvgen Biopharma’s exlinkibart saw its Phase Transition Success Rate (PTSR) decrease in castration-resistant prostate cancer (CRPC) after a Phase I trial was terminated. The PTSR dropped by 11 points to 53%.
The Phase I trial’s (NCT04694781) status was updated from completed to terminated on ClinicalTrials.gov on 13 March and GlobalData evaluated the asset on the following day.
According to the study’s ClinicalTrials.gov listing, the study was terminated by the sponsor due to product development strategy adjustment, not safety concern.
The purpose of the study was to establish the maximum tolerated dose of exlinkibart alone and in combination with Merck’s Keytruda (pembrolizumab) for the treatment of an advanced or metastatic malignancy. The study enrolled 18 patients before being terminated.
Exlinkibart acts by agonising CD137 and antagonising FCGR2B. The monoclonal antibody (mAb) is under development for the treatment of advanced or metastatic malignancies including lung cancer, melanoma, head and neck cancer squamous cell carcinoma, pancreatic cancer, gastrointestinal tract cancer and lymphoma.
Read the last edition:
Pipeline moves: Prospects drop after investigator-led trial of Roche’s Tecentriq terminatedNeed to know:
GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR and LoA. While LoA provides the probability of a drug ultimately receiving market authorization, PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses datapoints from individual drugs, clinical trials, regulatory milestones, company, and financial databases.
