OHB-607
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Every year, hundreds of thousands of infants worldwide are born extremely prematurely and, as a result, suffer from severe complications in their lungs, brain, and eyes that hinder their long-term development and quality of life. While prenatal steroids, surfactants, ventilators and improved resuscitation protocols have increased the survival rate of premature infants, there has been little progress in protecting their not fully developed organs from the trauma of life-saving measures at birth, including supplemental oxygen and breathing machines. OHB-607 has the potential to be the first breakthrough in more than 30 years to improve outcomes for these infants and their families.
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Oak Hill’s lead therapeutic candidate, OHB-607 (formerly TAK-607), is a proprietary, recombinant version of insulin-like growth factor 1 (IGF-1), the natural version of which is a key driver of fetal growth and development in utero, and its binding protein, IGFBP-3.
Mothers are the primary source of IGF-1 for the developing fetus, with the fetus producing very little of its own until reaching 30 weeks of gestational age. At birth, extremely premature infants, born at less than 28 weeks of gestational age, have low levels of IGF-1 which are associated with greater complication rates. OHB-607, as a human IGF-1 replacement, is designed to help promote continued development and maturation of vital organs and the vasculature that supports them.
OHB-607 has been evaluated in both preclinical and clinical studies. A Phase 2a clinical trial showed a statistically significant improvement in preventing severe bronchopulmonary dysplasia and a positive trend in reducing intraventricular hemorrhage (pre-specified secondary endpoints), with no significant safety signal observed.*
*Ley D, et al. J Pediatr 2019;206:56–65.Current trial:
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
OHB-101
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Rare autoimmune diseases are another area of huge unmet need. The complexity of the immune system means that there are numerous ways it can misfire, turning on its owner and causing chronic inflammation and immune cascades. People with conditions such as lupus, IgA nephropathy and idiopathic thrombocytopenic purpura suffer from debilitating long-term effects and often have limited treatment options with significant side effects. For example, half of all patients with IgA nephropathy will progress to end stage renal disease, requiring either dialysis or a kidney transplant to survive
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OHB-101 (Formerly TAK-752), a Phase 2a program, is currently being investigated for the treatment of a wide array of rare autoimmune diseases. It is a soluble recombinant version of the FcγR2B receptor that is designed to bind to immune complexes to prevent them from interacting with the fc gamma receptors that drive inflammation and autoimmune cascades. Preliminary clinical studies have been conducted in multiple autoimmune indications, including systemic lupus erythematosus, a rare autoimmune primary glomerular disease, and immune thrombocytopenia, a rare autoimmune blood disorder.
Preclinical Programs
Oak Hill Bio’s preclinical programs bring exciting potential. OHB-201, OHB-211 and OHB-301 are companion programs to OHB-101. They provide nuanced mechanisms compared to OHB-101 that create the potential for success in different indications. OHB-401 leverages Takeda's significant franchise in pKAL inhibition with a potential best-in-class oral small molecule.