Innovative Insights from Septerna on PTH1R Agonists for Treatment
Advancing Treatment for Hypoparathyroidism with SEP-786
Septerna, a burgeoning biotechnology company at the forefront of drug discovery targeting G protein-coupled receptors (GPCRs), is unveiling compelling preclinical data related to its innovative parathyroid hormone 1 receptor (PTH1R) program. This research was showcased at the prestigious American Society for Bone and Mineral Research (ASBMR) meeting, emphasizing the therapeutic potential of oral small molecule PTH1R agonists for managing hypoparathyroidism.
Key Findings from Preclinical Studies
The presented data indicate that Septerna’s PTH1R small molecule agonists effectively activate the receptor and influence crucial physiological processes that regulate calcium homeostasis. This mechanism mirrors the natural function of parathyroid hormone, offering substantial promise for patients affected by hypoparathyroidism.
In a continuing exploration of its findings, Septerna’s research revealed that these agonists maintain serum calcium and phosphate levels while enhancing vital bone turnover biomarkers. All of these effects were sustained over a testing period of 28 days through daily oral administration.
Clinical Trials and CEO Insights
As part of its commitment to advancing medical science, Septerna is currently engaging healthy volunteers in a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of its leading candidate, SEP-786. The company’s CEO, Jeffrey Finer, M.D., Ph.D., expressed enthusiasm regarding the data's implications, stating that they signify a potential shift in the treatment paradigm for individuals suffering from hypoparathyroidism. He emphasized the role of Septerna’s Native Complex Platform in effectively discovering novel therapies that target complex GPCRs.
Data Summary from the Presentation
The highlighted poster presentation, titled “Characterization of a Novel Oral Small Molecule PTH1R Agonist: Sustained Control of Serum Calcium and Modulation of Bone Biomarkers in TPTx Rats,” encapsulates vital findings:
- The activation of primary human renal proximal epithelial cells and a human osteoblast cell line exhibited similar engagement pathways when treated with PTH and the small molecule PTH1R agonist.
- Comparative studies in mouse models showcased both anabolic and catabolic bone activities, indicating positive outcomes following treatment with either PTH peptide or the small molecule agonist.
- A regimen incorporating daily oral PTH1R agonists demonstrated continuous, dose-dependent regulation of serum calcium and phosphate across a 28-day observation period.
- New findings indicate that daily administration of these agonists leads to an increased presence of active Vitamin D and upregulation of bone biomarkers in a dose-dependent manner over the same 28 days.
Understanding Hypoparathyroidism and SEP-786
SEP-786 represents a groundbreaking oral small molecule designed to specifically activate the PTH1R, targeting the underlying issues related to hypoparathyroidism. This condition is characterized by insufficient levels of parathyroid hormone, leading to a range of health challenges, including muscle cramps, fatigue, and severe complications like renal failure.
Patients traditionally rely on supplements that do not fully address their deficiency, or they require daily injections of PTH peptides. The promising preclinical safety studies of SEP-786 reveal its potential to normalize serum calcium levels and overall well-tolerance over an extended duration. With this, SEP-786 positions itself as a potentially transformative option in hypoparathyroidism treatment.
About Septerna and Its Innovative Approach
Founded in 2022, Septerna, Inc. is committed to redefining GPCR-targeted therapies through its proprietary Native Complex Platform. The company’s ambitious approach aims to tap into the unrecognized possibilities within GPCRs and facilitate the development of a diverse pipeline of product candidates. Initially, the company is concentrating its efforts on three therapeutic domains: endocrinology, immunology, and metabolic diseases. Through this innovative exploration, Septerna is on a path to impact the lives of patients significantly.
Frequently Asked Questions
What is SEP-786?
SEP-786 is an oral small molecule agonist targeting the parathyroid hormone 1 receptor (PTH1R), intended for treating hypoparathyroidism.
How does SEP-786 work?
It activates the PTH1R to regulate calcium levels and bone health, mimicking the effects of natural parathyroid hormone.
What were the key findings presented by Septerna?
The findings highlighted sustained regulation of calcium and phosphate levels and upregulation of bone turnover biomarkers over 28 days.
What stage is the clinical trial for SEP-786 currently in?
Septerna is conducting a Phase 1 clinical trial to evaluate the safety and pharmacokinetics of SEP-786 in healthy volunteers.
When was Septerna founded?
Septerna was established in 2022, focusing on GPCR-targeted drug discovery.
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