Phase 1a/b Clinical Trial

**What the phases mean:** - **Phase 1a:** First-in-human testing. The primary goal is **safety** — "Is this drug safe in humans at all?" A small group of patients receives escalating doses to find the maximum tolerated dose. - **Phase 1b:** Expansion phase. Now that safety is established, more patients receive the drug to gather preliminary efficacy data. - **Phase 2:** Larger group testing efficacy and further safety. - **Phase 3:** Large-scale comparison against the current standard of care. - **Phase 4:** Post-approval monitoring. **MHS context:** AL-605 is in Phase 1a/b, which means it's still early — primarily about safety and dose-finding. The fact that it's reaching patients at all is a milestone, but results are still preliminary. For MHS specifically, the CDK2 inhibitor would need to be **repurposed** (used for a different condition than originally designed) — meaning we'd need convincing preclinical data before a neuroinflammation trial could launch.