An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
Olfactive Biosolutions Granted Third Dual GLP-1 / GIP Patent to Repurpose Food Molecules for Weight Management and Blood Sugar Regulation
Olfactive Biosolutions was recently granted a third patent for inducing the secretion of GLP-1 and GIP, in U.S. patent US 12,171,727 B1 dated Dec. 24, 2024, Compositions and Methods for Treating Endocrine Diseases and Disorders. The patent specifically relates to oral formulations of natural food molecules for treating diabetes mellitus and obesity by modulating ectopic olfactory, taste and related receptor activity.
Olfactive Biosolutions uses proprietary formulations of food molecules to activate ectopic receptors in the body, replacing pharmaceuticals and treating myriad diseases.
Olfactive Biosolutions’ Pivit™ GLP-1 Weight Management activates olfactory receptors in the gut to induce the secretion of natural GLP-1 and GIP to facilitate weight management and regulation of blood sugar.
This new Pivit formulation will be available as a supplement sold direct to consumers beginning in 2025. Food and beverage manufacturers will also add Pivit Weight Management to their consumer products, bringing benefits consistent with current prescription-only pharmaceuticals without requiring any changes in consumer behavior or routines and without side effects.
“We are excited to have been granted this additional patent for GLP-1 Weight Management, another important formulation in our line of Pivit products. We now have five granted patents for treatment of diabetes, obesity, high blood sugar and hypertension,” said Nils Lommerin, President and CEO of Olfactive Biosolutions.
Pivit, the new name of the company’s flagship line of products, stimulates olfactory and taste receptors in the gut and elsewhere in the body, delivering similar physiological effects of active pharmaceutical ingredients at a fraction of the cost and without side effects.
Olfactory and taste receptors are not just in the nose and tongue, but everywhere in the body – the lungs, the vasculature, the gut, testes, heart and kidneys.
These ectopic receptors influence GLP-1 and GIP secretion, serotonin and dopamine secretion, blood pressure, muscle regeneration, bone remodeling, bronchodilation, kidney function and many other physiological pathways.
The Olfactive Biosolutions team has deep expertise in receptor protein science and the food & beverage industry. The company has several well-known biotechnology advisors from academia and the corporate world; its President and CEO is a former President, CEO and Director of Del Monte Foods.
āshibio Doses First Patient in ANDECAL study, a Phase 2/3 Trial of Andecaliximab for Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
āshibio, a privately held, clinical-stage biotechnology company developing novel therapeutics for the treatment of severe bone and connective tissue disorders, on January 23 announced the dosing of the first participant in its ANDECAL study, a Phase 2/3 clinical trial evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of andecaliximab in patients with fibrodysplasia ossificans progressiva (FOP). The dosing milestone for andecaliximab, āshibio’s lead product candidate, marks advancement of the company’s first clinical trial in a set of indications characterized by heterotopic ossification (HO), a pathological condition that causes abnormal bone formation in soft tissues such as muscles, tendons and ligaments.
“Heterotopic ossification, or HO, is a devastating condition with significant unmet need. We are initiating development in fibrodysplasia ossificans progressiva, a rare genetic disease characterized by severe and progressive HO leading to profound disability and shortened life span,” says āshibio Chief Executive Officer Pankaj Bhargava, MD. “People living with FOP lack adequate treatment options, and dosing of the first participant in the ANDECAL trial is a significant milestone in our mission to address their needs. Andecaliximab has extensive prior human clinical experience and safety data. Our team is dedicated to advancing this potential first-in-class treatment for HO, starting with FOP and expanding to other forms of non-genetic HO.”
Andecaliximab is a humanized antibody that specifically inhibits the matrix metalloproteinase-9 (MMP-9) enzyme, which researchers have identified as a potentially novel therapeutic target for FOP. The discovery that the MMP-9 enzyme could serve as a novel target for FOP was first published in the Journal of Bone and Mineral Research (JBMR) in February 2024.
The researchers evaluated a unique patient who harbors the classic mutation of FOP yet has minimal symptoms of the disease. The patient, who is now 36 years old, carries two mutations in the MMP-9 gene, which likely protect him from the devastating heterotopic ossification that most individuals living with FOP face. The effect of blocking MMP-9 was confirmed in mouse models of FOP in which knockout experiments and pharmacological treatments targeting MMP-9 showed substantial reduction of HO.
“This unique person revealed something that could significantly change the lives of people with FOP,” says Frederick S. Kaplan, MD, one of the study’s senior authors and the Isaac and Rose Nassau Professor of Orthopaedic Molecular Medicine at the University of Pennsylvania. “We hope that ongoing efforts will validate what we found and provide a path toward quality treatment for individuals with FOP.”
Edward Hsiao, MD, PhD, professor in the Division of Endocrinology and Metabolism and Director of the Metabolic Bone Clinic at the University of California, San Francisco, enrolled the first participant dosed in the ANDECAL study. “We are excited to initiate enrollment in the ANDECAL trial. I am grateful to the UCSF team and my colleague Dr. Kelly Wentworth for all their efforts in making this study available to our patients with FOP,” says Hsiao.
“The advancement of andecaliximab into the clinic is a significant milestone in our mission to improve the lives of those living with FOP and other forms of HO,” says āshibio chief medical officer, Deborah Wenkert, MD. “We are deeply grateful to the participants for taking part in this important study, and to the investigators for their partnership in helping to advance this potential treatment to address the unmet needs of individuals living with FOP.”
The U.S. Food and Drug Administration (FDA) has granted andecaliximab a Rare Pediatric Disease Designation (RPDD) for the treatment of FOP. An RPDD designation is granted to potential treatments for serious or life-threatening rare diseases with fewer than 200,000 patients in the U.S., and which primarily affect individuals under 18 years of age.
For additional trial details, visit the study page on clinicaltrials.gov.
Loading ...