ExtendBio, the clinical stage biopharmaceutical company developing advanced therapeutic peptides, today announced positive results from its first-in-human trial of EXT608. The interim analysis indicated that the drug was safe and well-tolerated, and showed a dose-dependent increase in serum calcium without any accompanying increase in urinary calcium.
Furthermore, it produced a prolonged suppression of endogenous parathyroid hormone (PTH), as expected. The early pharmacokinetic analysis suggests that EXT608 can be effectively dosed once-weekly, providing a strong rationale for proceeding to Phase 2 of clinical development and offering valuable guidance for selecting a starting dose.
ExtendBio’s EXT608 has made a major breakthrough in the treatment of hypoparathyroidism, with data showing that the drug is safe and well-tolerated with the potential to replace PTH for extended periods of time. This could result in improved patient adherence and an improved quality of life.
Tarik Soliman Ph.D., ExtendBio’s Co-Founder and Chief Executive Officer, is excited to move the drug forward and provide a viable solution for those living with this debilitating disease. With the potential to be a convenient treatment option, EXT608 is on the path to becoming a promising solution for physicians and patients.
Hypoparathyroidism is an enigmatic, yet serious endocrine disorder that affects an estimated 200,000 people globally. It is caused by a deficiency of parathyroid hormone (PTH), which is normally produced by the parathyroid glands located in the neck.
Without proper levels of PTH, calcium levels in the body can become dangerously low, leading to a range of physical health complications such as seizures, heart arrhythmias, and kidney damage. It can also cause psychological issues, such as depression and anxiety. Unfortunately, there is no cure for hypoparathyroidism, and the current standard of care (calcium and vitamin D supplementation) may not be enough to manage the condition.
Ext608, the lead program from ExtendBio, is a long-acting and parathyroid hormone-based therapy designed to provide the same physiological effects of PTH with significantly less frequent and more bioavailable dosing.
Currently, the Phase 1 trial is undergoing a double-blind and randomized placebo-controlled study involving 24 participants across 6 cohorts. As the trial nears completion, a full data analysis is taking place with the intention of presenting the results at an upcoming medical meeting.
EXT608 is a revolutionary, long-acting derivative of parathyroid hormone (PTH) developed by ExtendBio through its proprietary D-VITylation® platform. This compound is designed to be injected and provide full activity at the PTH receptor in a simple and convenient single-use disposable syringe.
In 2022, the FDA granted EXT608 Orphan Drug Designation and the preclinical and clinical development program has been supported by MassVentures and SBIR grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). EXT608 is poised to revolutionize the treatment of PTH-related disorders, offering a fast and easy solution to those in need.
About Extend Biosciences Inc.
Extend Biosciences Inc. is on the cutting-edge of biopharmaceuticals, utilizing their groundbreaking platform technology D-VITylation® to create next generation therapeutic peptides with enhanced pharmacokinetic properties.
By utilizing the natural pathway of vitamin D and the reversible binding of vitamin D binding protein, D-VITylation® prevents renal clearance of the vitamin D-conjugated therapeutic, increasing its half-life without compromising its efficacy. Among their impressive portfolio of D-VITylated assets is EXT418, a long-acting ghrelin that has the potential to treat cancer cachexia.