LifeMine's LIFE-001 Phase 1 grows to 160 as timeline slips 286 days
A third enrollment increase and a second completion-date push mark a highly unstable healthy-volunteer trial feeding a 65.1% endpoint-met read on a safety-only bar.
Executive Summary
- LifeMine Therapeutics increased the anticipated enrollment for its Phase 1 LIFE-001 trial from 150 to 160 participants, the third such increase since the trial's original 100-participant target in 2025 Press ReleasePress ReleaseJul 7, 2026.
- The primary completion date has moved twice, from January 31, 2026 to March 31, 2026 and then to November 13, 2026, a cumulative delay of 286 days that the trial's own risk assessment flags as high severity.
- The trial carries a Highly Unstable protocol stability label, with 8.74 registry change events per year against five total change events recorded to date, which lowers confidence that the November 2026 date holds without further revision.
- The AppliedXL model puts endpoint-met probability at 65.1% against a safety-only primary endpoint, adverse events, so the number reflects the odds the trial clears a tolerability bar rather than any measure of clinical benefit [NCT06904807, AXL-MODEL].
- LIFE-001's mechanism, molecular target, and intended indication remain undisclosed in the registry, which blocks any competitive or readthrough analysis until that information surfaces.
The change
LifeMine Therapeutics disclosed an enrollment increase for NCT06904807, its first-in-human study of LIFE-001, moving the anticipated participant count from 150 to 160 Press Release+1Press ReleaseJul 7, 2026A Phase I Study to Evaluate LIFE-001NCT06904807. It is the third enrollment revision since the trial's original target of 100 participants was set in 2025, following a jump to 120 in December 2025 and to 150 in March 2026. The study is a randomized, placebo-controlled Phase 1 design testing single ascending and multiple ascending subcutaneous doses of LIFE-001 in healthy adults aged 18 to 65, running at one facility in Australia.
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What's at stake
The primary completion date has moved twice in tandem with the enrollment changes, from January 31, 2026 to March 31, 2026, and then to November 13, 2026. That is a cumulative delay of 286 days, which the trial's own risk assessment flags as a high-severity signal, alongside 'medium' severity flags for the repeated primary completion date and enrollment changes themselves. The registry's protocol stability tool labels the trial Highly Unstable, citing 8.74 change events per year against five total recorded changes.
The endpoint bar
The trial's sole primary endpoint is adverse events, measured from predose through Day 22 for single-dose cohorts and through Day 43 to 56 for multiple-dose cohorts. Three secondary endpoints track pharmacokinetics: Cmax, plasma concentration, and time to maximum concentration. No results have been posted on ClinicalTrials.gov. Because the primary endpoint is a safety measure and not an efficacy measure, the AppliedXL model's 65.1% endpoint-met probability reflects the likelihood the safety bar is cleared, not evidence of therapeutic effect [NCT06904807, AXL-MODEL].
The information gap
LIFE-001's mechanism of action, molecular target, and intended indication are all listed as unknown or not applicable in the registry, and a mechanism classification search returned no match. The competitive trial search returned only LIFE-001's own study, with zero head-to-head comparator trials identified, so no direct rival program can be named. LifeMine Therapeutics' sponsor profile shows a single active trial in its portfolio, all in Recruiting status, which limits any cross-program readthrough within the company itself.
Reading the instability
A dose-escalation Phase 1 study widening its enrollment and pushing its completion date can reflect either a working safety-review process, adding cohorts as higher doses clear tolerability checks, or a trial encountering unexpected difficulty. The trial's arm structure, now including single ascending dose cohorts extending up to 1500mg and expanded multiple ascending dose cohorts, is consistent with a protocol still actively adding dose levels. The dossier does not disclose the reason behind the changes, so the two explanations cannot be distinguished from the registry record alone.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.