Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
NCT ID: NCT05514340
Last Updated: 2025-12-31
Study Results
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Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-09-06
2026-12-31
Brief Summary
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Detailed Description
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Additionally, therapeutic hypothermia is time-sensitive, having a narrow therapeutic window wherein therapy must be initiated within 6 hours of delivery to be effective. Timely initiation is also restricted to those neonatal units having adequate equipment and trained staff for therapeutic hypothermia. Death or disability is reported to occur in 55% of infants receiving therapeutic hypothermia. To the best of our knowledge, there is no pharmacotherapy available for the treatment of HIE. Hence, there is a significant unmet medical need.
ETB receptors located widely throughout the CNS are a necessary component of the developing nervous system and also promote neurorestorative processes involving neurogenesis and synaptogenesis. There was an increased expression of neural progenitor markers, NeuroD1 and Double Cortin, and neural markers for mature neurons, NeuN was observed in the sovateltide group compared to vehicle. In addition, Sovateltide increased the expression of presynaptic markers (synapsin1 and synaptophysin) and post-synaptic marker (Postsynaptic Density-95) compared to vehicle. Our results suggest that sovateltide treatment helps recruit and differentiate neural progenitor cells and augments synaptogenesis and endogenous neurorestorative processes.
Sovateltide is a synthetic analog of ET-1 synthesized in 1992 and is a highly specific ETB receptor agonist. We and others have conducted studies to determine the effects of sovateltide upon its interaction with neural ETB receptors and have found that it enhances angiogenesis and neurogenesis and promotes repair and regeneration. This is indicated by neuronal cell proliferation, alleviation of oxidative stress, improvement of neurological and motor functions, and increase in anti-apoptotic markers. In our preclinical study, sovateltide was shown to have neuroprotective effects by promoting repair and regeneration in the brain in a neonatal rat model of HIE. The study showed that sovateltide treatment alone or in combination with hypothermia significantly (p\<0.01) increased ETB receptor expression compared to vehicle-treated rat pups. In addition, enhanced VEGF and NGF expression were observed in rat pups treated with Sovateltide alone or in combination with hypothermia compared to vehicle-treated rat pups (p\<0.0001, p\<0.0001). Sovateltide alone and in combination with hypothermia also demonstrated a significantly reduced number of apoptotic cells compared to the control group. Furthermore, oxidative stress markers, including malondialdehyde, reduced glutathione, and superoxide dismutase was, significantly improved (p\<0.0001, p\<0.0001, p\<0.0001) in those rat pups treated with sovateltide.
Sovateltide was safe and well-tolerated in a Phase I trial (CTRI/2016/11/007509) in healthy human volunteers. In addition, we conducted human studies in patients with cerebral ischemic stroke (NCT04046484, CTRI/2017/11/010654; NCT04047563, CTRI/2019/09/021373), Alzheimer's disease (NCT04052737, CTRI/2017/12/016394), and acute spinal cord injury (NCT04054414, CTRI/2018/12/016667) patients. In summary, about 300 patients have been treated with sovateltide, and no drug-related adverse event has been reported to date.
We plan to conduct a phase II clinical study to evaluate the safety and efficacy of sovateltide therapy along with supportive management in neonates with perinatal asphyxia (HIE). The dose of sovateltide proposed for this phase II study is 0.3µg/kg same as used in the phase II study in ischemic stroke.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization.
In both treatment groups, subjects will be provided the best available standard of care.
TREATMENT
QUADRUPLE
Study Groups
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Normal Saline + Standard of care
Patients will receive the best available standard of care. Normal saline will be administered as an intravenous bolus over one minute every 3 hours on day 1, day 3, and day 6 post randomizations.
Normal Saline along with standard treatment
Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.
Sovateltide + Standard of care
Patients will receive the best available standard of care. Dose of sovateltide (0.3 µg/kg) will be administered as an intravenous bolus over one minute every 3 hours on day 1, day 3, and day 6 post randomizations.
Sovateltide along with standard treatment
Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm sovateltide along with standard treatment will be given for active comparison.
Interventions
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Normal Saline along with standard treatment
Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.
Sovateltide along with standard treatment
Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm sovateltide along with standard treatment will be given for active comparison.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Receiving supportive management for perinatal asphyxia
3. Perinatal depression, based on at least one of the following:
* Apgar score of \<5 at 10 minutes
* Need for resuscitation (chest compressions or mechanical ventilation) at birth
* pH \<7.00 or base deficit ≥ 16 mmol/liter in the cord or arterial blood within 60 minutes of birth
* Moderate/severe encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.
4. Informed consent by one of the parents or a legal representative
Exclusion Criteria
2. Admitted to hospital 12-hours after birth
3. A genetic or congenital condition that affects neuronal development
4. TORCH infection
5. Neonatal sepsis
6. Complex congenital heart disease
7. Severe dysmorphic feature
8. Microcephaly (head circumference \< 2 Standard Deviations below mean for gestational age)
ALL
No
Sponsors
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Pharmazz, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anil Gulati
Role: STUDY_CHAIR
Chairman and CEO
Locations
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Father Muller Medical College Hospital
Mangalore, Karnataka, India
Christian Medical College and Hospital
Ludhiana, Punjab, India
Niloufer Hospital
Hyderabad, Telangana, India
GSVM Medical College
Kanpur, Uttar Pradesh, India
Countries
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Central Contacts
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Facility Contacts
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Pavan Hedge
Role: primary
Gurmeet Kaur
Role: primary
Swapna Lingaldinna
Role: primary
Yashwant K Rao
Role: primary
References
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Ramos MD, Briyal S, Prazad P, Gulati A. Neuroprotective Effect of Sovateltide (IRL 1620, PMZ 1620) in a Neonatal Rat Model of Hypoxic-Ischemic Encephalopathy. Neuroscience. 2022 Jan 1;480:194-202. doi: 10.1016/j.neuroscience.2021.11.027. Epub 2021 Nov 23.
Ranjan AK, Gulati A. Sovateltide Mediated Endothelin B Receptors Agonism and Curbing Neurological Disorders. Int J Mol Sci. 2022 Mar 15;23(6):3146. doi: 10.3390/ijms23063146.
Gulati A, Agrawal N, Vibha D, Misra UK, Paul B, Jain D, Pandian J, Borgohain R. Safety and Efficacy of Sovateltide (IRL-1620) in a Multicenter Randomized Controlled Clinical Trial in Patients with Acute Cerebral Ischemic Stroke. CNS Drugs. 2021 Jan;35(1):85-104. doi: 10.1007/s40263-020-00783-9. Epub 2021 Jan 11.
Ranjan AK, Briyal S, Gulati A. Sovateltide (IRL-1620) activates neuronal differentiation and prevents mitochondrial dysfunction in adult mammalian brains following stroke. Sci Rep. 2020 Jul 29;10(1):12737. doi: 10.1038/s41598-020-69673-w.
Other Identifiers
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PMZ-1620/CT-2.4/2022
Identifier Type: -
Identifier Source: org_study_id