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. These complications can go on to 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.
There must be a strong commitment to looking for solutions for this vulnerable population.
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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OHB-607 is a straightforward replacement therapy approach. 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.* IGF-1 is crucial for organ development.
OHB-607, as a human IGF-1 replacement, is designed to make up for the deficiency that occurs in extremely preterm birth and thereby 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. It has shown broad-based improvements in preclinical studies.
In 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.*
*Hellström A, et al. Acta Paediatr 2016, 105: 576-586*Ley D, et al. J Pediatr 2019;206:56–65.
OHB-607 is now in a Phase 2b study - current trial: Footprints
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. There are over 80 immune complex driven autoimmune diseases. People with conditions such as lupus, IgA nephropathy (IgAN) and idiopathic thrombocytopenic purpura (ITP) suffer from debilitating long-term effects and often have limited treatment options, which often come with significant side effects. For example, half of all patients with IgAN will progress to end stage renal disease, requiring either dialysis or a kidney transplant to survive.
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OHB-101 (Formerly SM101, TAK-752), a Phase 2 program, is currently being investigated for the treatment of a wide array of immune complex driven 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 yielded positive results in multiple autoimmune indications, including systemic lupus erythematosus (SLE), a rare autoimmune primary glomerular disease, and ITP, a rare autoimmune blood disorder.
This first-in-class mechanism has the potential to provide therapeutic benefits alone or in combination. Nonclinical work supports its potential in additional areas of nephrology, dermatology, rheumatology, and vasculitis.
Recently generated compelling data through an academic collaboration not only further validates the mechanism of action but also identifies a potential biomarker-driven approach to patient selection. This capability could set the program apart from competitors and enhance its ability to take a precision medicine approach in delivering effective treatments.
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.