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NFC-1 · 4 trials · 3 indications
The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = "Never or rarely" to 3 = "Very often". The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value.
The CGI-I item is rated on a 7-point scale from 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", 7 = "Very much worse". Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response
| Arm | Type | Description |
|---|---|---|
| NFC-1 | EXPERIMENTAL | Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules for oral administration. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo capsules. |
| NFC-1 100 mg | EXPERIMENTAL | Single Dose of NFC-1 100 mg |
| NFC-1 200 mg | EXPERIMENTAL | Single Dose of NFC-1 200 mg |
| NFC-1 400 mg | EXPERIMENTAL | Single Dose of NFC-1 400 mg |
| NFC-1 800 mg | EXPERIMENTAL | Single Dose of NFC-1 800 mg |
| Single arm of 30 subjects | EXPERIMENTAL | Subjects will be administered single dose of NFC-1 to assess safety, tolerability, and pharmacokinetics, then proceed to continuous, daily administration of NFC-1 for 4 weeks to assess safety, tolerability, and impact on ADHD severity. |
| Name | Type | Description |
|---|---|---|
| NFC-1 | DRUG | NFC-1 is supplied as size 2 hard gelatin capsules. |
| Placebo | DRUG | Matching placebo capsules |
| NFC-1 100 mg | DRUG | - |
| NFC-1 200 mg | DRUG | - |
| NFC-1 400 mg | DRUG | - |
| NFC-1 800 mg | DRUG | - |
Inclusion Criteria: * Subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and Version 5 of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-5) ≥ 28 at Baseline with or without conventional ADHD therapy. * Subject has an int...
NFC-1 is an investigational small molecule being studied for 22q11.2 Deletion Syndrome and attention deficit hyperactivity disorder (ADHD). It is being developed by Avalo Therapeutics, Inc. (ticker: AVTX) as a treatment for these neuropsychiatric conditions in pediatric and adolescent patients.
NFC-1 is being developed by Avalo Therapeutics, Inc., which trades under the ticker AVTX. The company is advancing NFC-1 as a small molecule therapeutic candidate for rare disease indications including 22q11.2 Deletion Syndrome and ADHD.
NFC-1 is in Phase 1 clinical development. It has completed clinical trials, including Phase 1 and Phase 2 studies, but is not FDA approved. The drug remains investigational and is being evaluated for safety and efficacy in its target indications.
NFC-1 has been studied in completed trials including NCT03006367, a Phase 1 pharmacokinetic and tolerability study in ADHD; NCT02895906, a Phase 1 safety and efficacy study in 22q11.2DS; NCT02777931, a Phase 2 efficacy and safety study in genetic disorders with ADHD; and NCT02286817, a Phase 1 pharmacokinetic and dose escalation study in ADHD.