Altasciences Conducts Preclinical Studies in Support of Verve Therapeutics’ Gene Editing Approach for Cardiovascular Disease
Laval, Quebec, March 12, 2021 – Altasciences is proud to have conducted preclinical studies for Verve Therapeutics that support the development and advancement of Verve’s gene editing approach to treating cardiovascular diseases. Altasciences’ Seattle team performed intravenous preclinical studies, including supporting analyses of pharmacodynamic markers and whole liver DNA editing, in non-human primates, that show that a single intravenous infusion of Verve’s gene editor achieved a 59% reduction in blood low-density lipoprotein cholesterol (LDL-C) at two weeks, which has been maintained beyond six months post treatment. No adverse events were reported during the study and in studies of primary human hepatocytes, clear evidence of on-target editing was observed.
“We are excited to have supported the advancement of Verve’s gene editors for cardiovascular disease, and to have contributed to the development of an entirely new approach to treating heart disease, which remains the leading cause of death among men and women worldwide,” says Mike Broadhurst, General Manager of Altasciences’ preclinical facility.
More information on Verve Therapeutics’ program can be found here.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
Contract Pharma: Altasciences Doubles Size of PA CDMO Facility
Altasciences Doubles Square Footage of their CDMO Facility
Laval, Quebec, March 9, 2021 – Altasciences, a fully integrated early phase CRO/CDMO has started the expansion of their CDMO facility in Philadelphia, PA. The additional 35,000-square-foot building directly adjoins the current location, and will be fully renovated to meet the growing business needs. Phase 1 construction, including warehouse and cGMP manufacturing suites, is expected to be completed by the end of 2021.
The new space, with its 24-foot ceilings, will be configured to include a ~8,750-square-foot warehouse, a ~8,750-square-foot Grade C/D manufacturing area, and a 17,500-square-foot client-dedicated cGMP manufacturing area.
“This expansion ensures that we are in an excellent position to continue to meet the needs of our clients and remain at the forefront of pharmaceutical manufacturing technology. We look forward to seeing this ambitious project come to completion in the coming months,” says Ben Reed, Vice President, Manufacturing, at Altasciences.
Altasciences acquired the Philadelphia CDMO facility in February of 2020, and purchased the new building in December of 2020.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
Altasciences Conducts Phase I Study in Healthy Normal Subjects for RLS-0071 for Treatment of Acute Lung Injury Due to COVID-19 Pneumonia
Laval, Quebec, March 3, 2021– Altasciences is pleased to support ReAlta Life Sciences by conducting a Phase I trial to evaluate RLS-0071 for treatment of Acute Lung Injury (ALI) as a result of viral infections, such as COVID-19, respiratory syncytial virus (RSV), and influenza. As part of the ReAlta ALI program underway, the Phase I trial is a single-ascending dose, randomized, double-blind, placebo-controlled, adaptive-design study to evaluate the safety, tolerability, PK, and PD of RLS-0071 in healthy subjects, performed at the Altasciences clinical pharmacology unit in Montreal, Canada.
Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences, says, “Our teams are proud to have the opportunity to be involved in the clinical conduct and bioanalytical analysis for this important first-in-human trial. Being able to prioritize COVID-19 therapies by contributing critical data to the development of potentially life-altering medications such as RLS-0071 is tremendously rewarding to our teams.”
Click here to read the ReAlta press release on RLS-0071, and to learn more about ReAlta Life Sciences.
“The results from our healthy volunteers study will inform our ongoing ALI study in hospitalized COVID-19 patients, as well as future programs … we look forward to obtaining data from this study as it progresses to market,” says Ulrich Thienel, M.D., Ph.D., ReAlta’s Chief Executive Officer.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
Protocol Design Concepts in Phase I Ethnobridging Clinical Trials
In Phase I ethnobridging clinical trials, there are three primary protocol design concepts utilized.
Contract Pharma: Altasciences Contributes to Vibegron Approval
Altasciences Performs Phase I Studies for FDA Approval of Vibegron
Laval, Quebec, February 23, 2021 – Altasciences is pleased to have contributed to the recent FDA approval of Vibegron, by performing multiple early phase clinical trials. Vibegron is a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. The approval was announced by Urovant Sciences on December 23, 2020.
“We take tremendous pride in contributing to the FDA approval of much-needed medicines that improve the health and wellbeing of patients,” said Amy Denvir, General Manager at Altasciences’ Kansas clinical pharmacology unit. “Working with Urovant Sciences on this program has been a pleasure, and we are delighted to see it come to fruition.”
Altasciences’ expert clinical teams provided clinical support for two drug-drug interaction studies and a bioavailability trial, conducted in 2018 and 2019, in healthy subjects. These trials were supported by Altasciences’ data services team, who performed the full data management and reporting for the associated clinical studies.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com