Q4 2022 Trial Dashboards
Clinical Trials for Parkinson’s Disease Drug Therapies: What Happened During Q4 2022?
Recruiting began for six trials (excluding a large Phase 3 trial from University College London of antidepressants in PD for which the clinicaltrials.gov record had not been updated in 4 years). Most notable was the STEM-PD stem cell trial in Europe and a Phase 2 trial from Jazz Pharmaceuticals of the T-type selective calcium channel modulator suvecaltamide for residual tremor despite standard of care therapy.
Five trials completed enrollment including two Phase 2 trials in patients with cognitive impairment due to PD or Lewy Body Dementia: NYX-458 a NMDA receptor modulator from Aptinyx and ATH-1017 (which enhances hepatocyte growth factor activity) from Athira.
Reached clinical completion?
Another five trials reached clinical completion including Phase 2 trials of:
• The iron chelator deferipone from ApoPharma
• The GLP-1 agonist liraglutide from Cedars Sinai hospital
• The dopamine D3 antagonist mesdopetam (for levodopa-induced dyskinesia) from Integrative Research Laboratories
Been delayed (or accelerated)?
Delays in completion date were disclosed for 15 studies (for 4 the previous completion date had already passed suggesting the sponsor was behind on updating clinicaltrials.gov ). Eight studies disclosed a delay of at least 90 days. One study reported an accelerated completion date.
Completion projected within the next six months?
Twenty-one trials are projected to complete by Q2 2023 with 11 to complete in Q1 2023
• Included are the UK Phase 3 trial of antidepressants in PD and Cerevel’s Phase 3 trial of tavapadon for motor fluctuations
• Phase 2 highlights are trials of SunPharma’s Bcr/Abl kinase inhibitor K0706 and Neuraly’s pegylated exenatide
Q4 2022 Trial Results Headlines (ref. dashboard 4)
What trials have . . .
Q4 2022 Trial Status Headlines (ref. dashboards 1-3)
What trials have . . .
Note that clinical trial results are often disclosed for the first time via company press releases and/or investor presentations. For public companies this is often driven by requirements for timely disclosure of material events deemed likely to inform investment decisions. These corporate disclosures typically include only the key top-line results. More detailed trial results may be disclosed via posters or presentations at scientific conferences. Eventually comprehensive trial results are generally published in medical journals sometimes as a “pre-print” (that has not yet been reviewed by experts not involved in the trial) and ultimately as a final peer-reviewed manuscript. Trial results can also be posted by sponsors in the clinicaltrials.gov database, but this often lags behind other routes of disclosure.
Had results disclosed for the first time?
Results for eleven trials were disclosed for the first time. Included were negative Phase 2 trials with deferiprone (iron chelator) and AKST4290-211 (CCR3 inhibitor), a small Phase 2 study with PT320 (ER exenatide) that missed the primary endpoint but the sponsor (Peptron) was optimistic for further development based on secondary endpoints, and three early trials that lacked primary efficacy endpoints with statistical testing but had favorable results claimed on secondary efficacy, PK-PD and safety endpoints (AL101 from Elector & GSK, NE3107 from Biovie, and CST103 & CST107 from CuraSen Therapeutics).
Had additional detail on results disclosed?
Additional results were disclosed for six trials for which at least top-line results had been previously reported. Notable were peer-reviewed manuscripts for Enterin’s positive Phase 2 study with ENT-01 for constipation, the Abbvie positive Phase 3 study with their sub-cutaneous LD/CD pump showing reduced motor fluctuations relative to oral LD/CD, and Annovis’s Phase 1/2 study with butanetap for which secondary efficacy and safety results were stated to support further development. There was also a conference presentation on a Phase 2 study with PT-001 (ketamine) from Pharmather supporting efficacy for levodopa-induced dyskinesia.
Analyzing the Parkinson's disease clinical trial pipeline to facilitate patient collaboration in research.