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NOT YET RECRUITING

NCT07861126

PHASE3

Sovateltide for the Treatment of Acute Traumatic Brain Injury

Sponsor: Pharmazz, Inc.

View on ClinicalTrials.gov

Summary

Traumatic brain injury (TBI) remains a leading cause of global disability, yet current clinical management is limited to supportive care and pressure stabilization using hyperosmolar therapies like mannitol and hypertonic saline. These strategies fail to address the destructive cellular cascades that persist long after the initial impact, leaving 66.3% of severe TBI patients with permanent cognitive and neurological deficits. To bridge this critical unmet medical need, the therapeutic focus must shift toward neuroprotective and neuroregenerative agents that actively block secondary injury cascades such as excitotoxicity, apoptosis, and chronic neuroinflammation. Sovateltide is a selective endothelin-B receptor agonist. It was previously reported to reduce apoptosis, stimulate neurogenesis, and improve functional recovery. Unlike most TBI candidates restricted to preclinical phases, sovateltide possesses a robust human safety and tolerability profile established across Phase I, II, III, and IV ischemic stroke trials. We conducted a preclinical study in Wistar rats with induced TBI and showed that sovateltide effectively preserved BBB integrity, a critical determinant of post-injury outcomes, and significantly reduced neuronal apoptosis, as evidenced by decreased expression of caspase-3 and caspase-6, key markers of programmed cell death. Treated animals also exhibited notable improvements in neurobehavioral performance, reflecting functional recovery likely attributable to the drug's antioxidant, anti-inflammatory, and anti-apoptotic mechanisms. These results align with earlier evidence showing that ETB receptor activation enhances angiogenesis, neurogenesis, and synaptic remodeling, processes essential for neural repair following brain injury. The present study has been designed to advance sovateltide (IRL-1620) into a pivotal Phase III clinical trial for acute traumatic brain injury (TBI). With millions affected annually and zero approved neuroprotective pharmacotherapies available, this milestone marks a critical step forward in addressing one of modern medicine's greatest unmet needs. By harnessing our proprietary neural repair discovery platform, sovateltide targets the cascade of secondary cell death while stimulating neurogenesis and angiogenesis. Building on the strong momentum of our ongoing global Phase III RESPECT-ETB study in acute ischemic stroke, this study will further validate the broad therapeutic potential of our endothelin-B receptor platform across severe acute neurovascular conditions.

Official title: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Assess the Efficacy and Safety of Sovateltide in Patients With Traumatic Brain Injury

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2026-12

Completion Date

2028-03

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Traumatic Brain Injury

Interventions

DRUG

Placebo

The reference product is a matching placebo for sovateltide. It is a sterile lyophilized injection consisting of excipients formulated without the active ingredient in a 5.0 mL vial, to be reconstituted in 5 mL of normal saline (0.9% Sodium Chloride Injection).

DRUG

Sovateltide

The test product is sovateltide. It is available as a lyophilized injection containing 30 μg of sovateltide in a 5.0 mL vial, to be reconstituted in 5 mL normal saline (0.9% Sodium Chloride Injection).

Inclusion Criteria: A participant will be eligible for inclusion in the study if the participant fulfills the following criteria: 1. Adult male or female aged 18-90 years 2. Consent must be obtained prior to any study-specific procedure from the participant or, if the participant lacks capacity to provide informed consent, from the participant's Legally Authorized Representative (LAR), in accordance with applicable law and IRB requirements. 3. Clinical diagnosis of closed traumatic brain injury (TBI), classified as moderate to severe, with a post-resuscitation Glasgow Coma Scale (GCS) score of 5 to 13, inclusive, at screening (moderate TBI: GCS 9-13; eligible severe TBI range: GCS 5-8). 4. Radiological confirmation of TBI on neuroimaging (diffuse injury II-V, Marshall's CT Classification). 5. At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive). 6. The participant is \<48 hours from the time of TBI onset when the first dose of sovateltide is administered. The time of TBI onset is when the injury occurred. 7. Reasonable expectation of availability to receive the full sovateltide course of therapy and to be available for subsequent follow-up visits. Exclusion Criteria: A participant will not be considered eligible for inclusion in this study if the participant meets any of the following exclusion criteria: 1. TBI caused by penetrating injury (e.g., gunshot wound) rather than blunt trauma. 2. Isolated epidural hematoma. 3. Suspected or confirmed spinal cord injury. 4. Severe cardiac or hemodynamic instability prior to randomization. 5. Life expectancy of less than 72 hours as determined by the Investigator. 6. Pregnant or lactating women. 7. Known medical history of neurological (other than current TBI) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study. 8. Evidence of any other major life-threatening or serious medical condition, such as severe renal, hepatic, and cardiovascular disease, which would prevent completion of the study protocol, impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or might cause harm to the participant. 9. Concurrent participation in any other therapeutic clinical trial.

Clinical Research Directory

Sovateltide for the Treatment of Acute Traumatic Brain Injury

Summary

Key Details

Conditions

Interventions

Eligibility Criteria