The Injection of Ghrelin (OXE-103) Improves Subacute Concussion Symptom Burden and Quality of Life
Concussions remain the leading form of traumatic brain injury. Despite this, there is a paucity of pharmacologic and evidence-based treatments. The objective of this study was to investigate the benefit of Ghrelin (OXE-103) as a novel treatment for subacute concussion. The study consisted of an open...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Mary Ann Liebert
2025-01-01
|
| Series: | Neurotrauma Reports |
| Subjects: | |
| Online Access: | https://www.liebertpub.com/doi/10.1089/neur.2025.0038 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850272275578748928 |
|---|---|
| author | Michael Rippee Michael Wyand Jamie Chen Amelia Kirchhoff-Rowald Suzanne Hunt Vishal Bansal |
| author_facet | Michael Rippee Michael Wyand Jamie Chen Amelia Kirchhoff-Rowald Suzanne Hunt Vishal Bansal |
| author_sort | Michael Rippee |
| collection | DOAJ |
| description | Concussions remain the leading form of traumatic brain injury. Despite this, there is a paucity of pharmacologic and evidence-based treatments. The objective of this study was to investigate the benefit of Ghrelin (OXE-103) as a novel treatment for subacute concussion. The study consisted of an open-label treatment arm (OXE-103) with a nontreatment concurrent control arm receiving standard of care (SOC-only). Participants had a documented concussion, within 28 days of injury, and a Post-Concussion Symptom Scale (PCSS) of 20 or more. A total of 19 subjects completed the study: 13 treatments and 6 SOC. Treatment consisted of OXE-103 40 μg/kg twice daily by self-injection for 14 days. Main Outcome Measures were change in PCSS and Quality of Life after Brain Injury–Overall Scale (QOLIBRI-OS). Outcome measures were assessed at days 1, 4, 8, 11, 15, 21, and 44. A secondary outcome was 20% improvement on either which was considered a clinically meaningful response. We found a decrease in PCSS from baseline with OXE-103 (median −34 [interquartile range {IQR}: −44, −24]) at day 44 versus SOC (median −7 [IQR: −22, 16]) at day 44. We also found an improvement in QOLIBRI-OS from baseline with OXE-103 (median 21 [IQR: 12.5, 50]) at day 44 versus SOC (2 [IQR: –25, 20.8]) at day 44. 85% (95% confidence interval [CI]: 53, 98) of subjects treated with OXE-103 had a clinically meaningful response at day 44 on PCSS versus 33% (95% CI: 4, 78) of subjects in the SOC arm. When looking at improvement in QOLIBRI-OS, 85% (95% CI: 53, 98) of subjects treated with OXE-103 had a clinically meaningful response at day 44 versus 33% (95% CI: 4, 78) in the SOC arm. We conclude that subjects treated with OXE-103 showed improved PCSS and QOLIBRI-OS scores compared to those receiving only standard therapy. We recognize the limitations of this study, including small sample size and lack of randomization. The results indicate that OXE-103 is a potential therapeutic agent to treat patients with ongoing concussion symptoms. A larger, multicenter, randomized, placebo-controlled trial would be an important next step. |
| format | Article |
| id | doaj-art-e46c88fb593546eb9db274df9c0e57c5 |
| institution | OA Journals |
| issn | 2689-288X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Mary Ann Liebert |
| record_format | Article |
| series | Neurotrauma Reports |
| spelling | doaj-art-e46c88fb593546eb9db274df9c0e57c52025-08-20T01:51:53ZengMary Ann LiebertNeurotrauma Reports2689-288X2025-01-016140241210.1089/neur.2025.0038The Injection of Ghrelin (OXE-103) Improves Subacute Concussion Symptom Burden and Quality of LifeMichael Rippee0Michael Wyand1Jamie Chen2Amelia Kirchhoff-Rowald3Suzanne Hunt4Vishal Bansal5University of Kansas Medical Center, Kansas City, Kansas, USA.Oxeia Biopharmaceuticals, Boston, Massachusetts, USA.University of Kansas Medical Center, Kansas City, Kansas, USA.University of Kansas Medical Center, Kansas City, Kansas, USA.University of Kansas Medical Center, Kansas City, Kansas, USA.Oxeia Biopharmaceuticals, Boston, Massachusetts, USA.Concussions remain the leading form of traumatic brain injury. Despite this, there is a paucity of pharmacologic and evidence-based treatments. The objective of this study was to investigate the benefit of Ghrelin (OXE-103) as a novel treatment for subacute concussion. The study consisted of an open-label treatment arm (OXE-103) with a nontreatment concurrent control arm receiving standard of care (SOC-only). Participants had a documented concussion, within 28 days of injury, and a Post-Concussion Symptom Scale (PCSS) of 20 or more. A total of 19 subjects completed the study: 13 treatments and 6 SOC. Treatment consisted of OXE-103 40 μg/kg twice daily by self-injection for 14 days. Main Outcome Measures were change in PCSS and Quality of Life after Brain Injury–Overall Scale (QOLIBRI-OS). Outcome measures were assessed at days 1, 4, 8, 11, 15, 21, and 44. A secondary outcome was 20% improvement on either which was considered a clinically meaningful response. We found a decrease in PCSS from baseline with OXE-103 (median −34 [interquartile range {IQR}: −44, −24]) at day 44 versus SOC (median −7 [IQR: −22, 16]) at day 44. We also found an improvement in QOLIBRI-OS from baseline with OXE-103 (median 21 [IQR: 12.5, 50]) at day 44 versus SOC (2 [IQR: –25, 20.8]) at day 44. 85% (95% confidence interval [CI]: 53, 98) of subjects treated with OXE-103 had a clinically meaningful response at day 44 on PCSS versus 33% (95% CI: 4, 78) of subjects in the SOC arm. When looking at improvement in QOLIBRI-OS, 85% (95% CI: 53, 98) of subjects treated with OXE-103 had a clinically meaningful response at day 44 versus 33% (95% CI: 4, 78) in the SOC arm. We conclude that subjects treated with OXE-103 showed improved PCSS and QOLIBRI-OS scores compared to those receiving only standard therapy. We recognize the limitations of this study, including small sample size and lack of randomization. The results indicate that OXE-103 is a potential therapeutic agent to treat patients with ongoing concussion symptoms. A larger, multicenter, randomized, placebo-controlled trial would be an important next step.https://www.liebertpub.com/doi/10.1089/neur.2025.0038concussiondrug therapyghrelinmild traumatic brain injury |
| spellingShingle | Michael Rippee Michael Wyand Jamie Chen Amelia Kirchhoff-Rowald Suzanne Hunt Vishal Bansal The Injection of Ghrelin (OXE-103) Improves Subacute Concussion Symptom Burden and Quality of Life Neurotrauma Reports concussion drug therapy ghrelin mild traumatic brain injury |
| title | The Injection of Ghrelin (OXE-103) Improves Subacute Concussion Symptom Burden and Quality of Life |
| title_full | The Injection of Ghrelin (OXE-103) Improves Subacute Concussion Symptom Burden and Quality of Life |
| title_fullStr | The Injection of Ghrelin (OXE-103) Improves Subacute Concussion Symptom Burden and Quality of Life |
| title_full_unstemmed | The Injection of Ghrelin (OXE-103) Improves Subacute Concussion Symptom Burden and Quality of Life |
| title_short | The Injection of Ghrelin (OXE-103) Improves Subacute Concussion Symptom Burden and Quality of Life |
| title_sort | injection of ghrelin oxe 103 improves subacute concussion symptom burden and quality of life |
| topic | concussion drug therapy ghrelin mild traumatic brain injury |
| url | https://www.liebertpub.com/doi/10.1089/neur.2025.0038 |
| work_keys_str_mv | AT michaelrippee theinjectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT michaelwyand theinjectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT jamiechen theinjectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT ameliakirchhoffrowald theinjectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT suzannehunt theinjectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT vishalbansal theinjectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT michaelrippee injectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT michaelwyand injectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT jamiechen injectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT ameliakirchhoffrowald injectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT suzannehunt injectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife AT vishalbansal injectionofghrelinoxe103improvessubacuteconcussionsymptomburdenandqualityoflife |