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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 developed for 22q11.2 Deletion Syndrome, Attention Deficit Disorder With Hyperactivity, and Attention-deficit Hyperactivity Disorder (ADHD). It is being studied in adolescents and children with these neuropsychiatric conditions.
NFC-1 is being developed by Avalo Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol AVTX. The company is conducting clinical trials to evaluate the safety and efficacy of NFC-1 in patients with ADHD and related genetic disorders.
NFC-1 is in Phase 1 clinical development. While one completed trial was listed as Phase 2, the overall development program is currently in the early stages, with the most recent trials being Phase 1 studies. NFC-1 is investigational and has not been approved by regulatory authorities.
NFC-1 has been studied in four completed clinical trials: NCT02286817, a Phase 1 pharmacokinetic and dose escalation study in adolescents with ADHD; NCT02777931, a Phase 2 efficacy and safety study in adolescents with genetic disorders impacting mGluR and ADHD; NCT02895906, a Phase 1 study in subjects with 22q11.2 Deletion Syndrome; and NCT03006367, a Phase 1 pharmacokinetic study in children with ADHD.
NFC-1 targets the metabotropic glutamate receptor (mGluR) pathway, which is implicated in certain genetic disorders that affect brain signaling. By modulating this pathway, NFC-1 is intended to address neuropsychiatric symptoms associated with conditions like ADHD and 22q11.2 Deletion Syndrome.
NFC-1 is not known to have any alternative names. It is a unique investigational compound being developed by Avalo Therapeutics for the treatment of ADHD and related genetic disorders. No other names for this drug have been reported.