Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M6495 · 1 trial · 1 indication
Number of participants with clinically significant change from baseline will be reported.
| Arm | Type | Description |
|---|---|---|
| M6495 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| M6495 | DRUG | Participants will receive escalated dose of M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4. |
| Placebo | DRUG | Participants will receive placebo matched to M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4. |
Inclusion Criteria: * Kellgren Lawrence (KL) radiological Grade of 2 to 4 in the target knee * Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore of greater than or equal to (\>=) 40 out of 100 in the target knee at screening * Primary or post-traumatic femorotibia...
M6495 is an investigational small molecule being developed for the treatment of osteoarthritis of the knee. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in clinical trials.
M6495 is an anti-ADAMTS-5 nanobody, meaning it targets the ADAMTS-5 enzyme, a disintegrin and metalloproteinase with thrombospondin motifs. By inhibiting ADAMTS-5, M6495 is designed to potentially modify the progression of osteoarthritis, though its exact mechanism in this context is still under clinical investigation.
M6495 is being developed by Merck KGaA, a multinational pharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of knee osteoarthritis.
M6495 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it is not yet approved for commercial use. Further clinical studies would be needed to advance it through later phases of development.
M6495 has been studied in a completed Phase 1 clinical trial with the identifier NCT03583346. This trial was a multiple ascending dose study in participants with knee osteoarthritis, enrolling 32 participants in Denmark. The trial was randomized, double-blind, and placebo-controlled.
Yes, M6495 is an anti-ADAMTS-5 nanobody. It is designed to target ADAMTS-5, an enzyme involved in cartilage breakdown. This mechanism is being investigated for its potential to treat osteoarthritis of the knee.