Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVTX-009 Regimen 1 · 1 trial · 1 indication
HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.
| Arm | Type | Description |
|---|---|---|
| AVTX-009 Regimen 1 | EXPERIMENTAL | Patients will receive AVTX-009 regimen 1. |
| AVTX-009 Regimen 2 | EXPERIMENTAL | Patients will receive AVTX-009 regimen 2. |
| Placebo | PLACEBO_COMPARATOR | Patients will receive matching placebo. |
| Name | Type | Description |
|---|---|---|
| AVTX-009 Regimen 1 | DRUG | AVTX-009 will be administered as a subcutaneous injection every 4 weeks. |
| AVTX-009 Regimen 2 | DRUG | AVTX-009 will be administered as a subcutaneous injection every 2 weeks. |
| Placebo | DRUG | Matching placebo will be administered as a subcutaneous injection every 2 weeks. |
Inclusion Criteria: 1. Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening. 2. At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3. Exclusion Criteria: 1. Has a draining fistula count of ≥ 20....
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib, Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | povorcitinib, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Remibrutinib, Secukinumab |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE2 | Duvakitug, Brivekimig, SAR445399 |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Olatorepatide |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY072 |
| Oruka Therapeutics, Inc. | ORKA | 1 | PHASE2 | ORKA-002 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE1 | SAR447971 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE1 | Soquelitinib |
AVTX-009 Regimen 1 is being developed for the treatment of moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition. It is an investigational small molecule therapy being studied in adults 18 years and older with this dermatologic indication.
AVTX-009 Regimen 1 is being developed by Avalo Therapeutics, Inc., which trades on the Nasdaq under the ticker AVTX. The company is advancing this small molecule candidate in dermatology, specifically for moderate to severe hidradenitis suppurativa.
AVTX-009 Regimen 1 is in Phase 2 clinical development. A Phase 2 trial evaluating its efficacy and safety in patients with moderate to severe hidradenitis suppurativa has been completed. The drug is investigational and has not been approved by the FDA.
AVTX-009 Regimen 1 has been studied in one Phase 2 clinical trial, NCT06603077, titled A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa. The trial enrolled 253 participants across the United States, Australia, Bulgaria, Canada, Czechia, France, Germany, Greece, Italy, Poland, Slovakia, Spain, and Turkey, and is now completed.
The Phase 2 trial NCT06603077 was a randomized, double-blind, placebo-controlled study evaluating AVTX-009 in adults with moderate to severe hidradenitis suppurativa. It enrolled 253 participants, included both male and female patients aged 18 years and older, and did not enroll healthy volunteers.