Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMG-007 · 3 trials · 4 indications
Incidence and severity of TEAEs, including treatment-emergent SAEs, AESIs, and AEs leading to discontinuation
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
| Arm | Type | Description |
|---|---|---|
| IMG-007 Dose | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 1 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 2 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 3 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 4 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 5 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 6 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 7 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| Placebo Crossover Dose 1 | PLACEBO_COMPARATOR | Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. |
| Placebo Crossover Dose 2 | PLACEBO_COMPARATOR | Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. |
| IMG-007 Dose 1 (300 mg) | EXPERIMENTAL | IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks |
| IMG-007 Dose 2 (600 mg) | EXPERIMENTAL | IMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks |
| Name | Type | Description |
|---|---|---|
| IMG-007 | DRUG | Participants will receive IMG-007 subcutaneously. |
| Placebo | DRUG | Participants will receive a placebo subcutaneously. |
Enrolling by invitation participants with moderate to severe AD who have completed IMG-007-203
Top 20 of 25 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 9 | PHASE3 | Upadacitinib, Lutikizumab |
| Pfizer Inc. | PFE | 10 | PHASE3 | Abrocitinib, PF-08049820, PF-07275315, PF-07264660, PF-07832837 |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Lebrikizumab |
| Sanofi SA Sponsored ADR | SNY | 13 | PHASE3 | Amlitelimab, Dupilumab SAR231893, Dupilumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 4 | PHASE3 | dupilumab, REGN20423 |
| Incyte Corporation | INCY | 3 | PHASE3 | Ruxolitinib |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Apogee Therapeutics, Inc. | APGE | 3 | PHASE2 | APG777, APG990 |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | GIA632, GHZ339 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE2 | Soquelitinib |
| Nektar Therapeutics | NKTR | 1 | PHASE2 | Rezpegaldesleukin |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE2 | Barzolvolimab |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
| Aclaris Therapeutics, Inc. | ACRS | 1 | PHASE2 | ATI-045 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | Bempikibart |
| Turn Therapeutics Inc. | TTRX | 1 | PHASE2 | GX-03 |
| Arcutis Biotherapeutics Inc | ARQT | 1 | PHASE1 | ARQ-234 |
| Generate Biomedicines, Inc. | GENB | 1 | PHASE1 | GB-7624 |
IMG-007 is an investigational small molecule being developed for Alopecia Areata (AA) and Atopic Dermatitis. It is in clinical development and has not been approved for any indication. ImageneBio, Inc. is evaluating it in adults with moderate-to-severe Atopic Dermatitis and in adults with Alopecia Areata.
IMG-007 targets OX40, a receptor. OX40 is a co-stimulatory receptor involved in T cell activation and survival, and targeting it is intended to modulate immune signaling relevant to inflammatory skin conditions such as Atopic Dermatitis and Alopecia Areata. IMG-007 is a small molecule directed at this receptor.
IMG-007 is being developed by ImageneBio, Inc., which trades under the ticker IMA. The company is the sponsor of the clinical program evaluating IMG-007 in Alopecia Areata and Atopic Dermatitis, including Phase 1 and Phase 2 studies conducted in the United States, Canada, Australia, and New Zealand.
IMG-007 is in Phase 1 development overall, with Phase 2 studies now underway in Atopic Dermatitis. It is investigational and has not been approved by the FDA. A completed Phase 1 study evaluated IMG-007 in adult Alopecia Areata participants, and two Phase 2 trials are active in moderate-to-severe Atopic Dermatitis.
IMG-007 has been studied in NCT06060977, a completed Phase 1 trial in adult Alopecia Areata participants, and is being evaluated in two Phase 2 Atopic Dermatitis trials: NCT07037901, which is recruiting, and NCT07734415, which is enrolling by invitation. The Phase 2 trials together plan to enroll about 805 adults across multiple countries.
IMG-007 is not approved; it is an investigational drug still in clinical development. ImageneBio, Inc. is evaluating IMG-007 in Phase 1 and Phase 2 trials for Alopecia Areata and Atopic Dermatitis. Approval status would depend on completion of clinical development and regulatory review, which have not occurred.