Drug-Drug Interactions - What you Should Know
the study of Drug-Drug Interactions
Altasciences Conducts Successful First-in-Human Trial for Acurx Pharmaceuticals' Novel Antibiotic to Treat C. Difficile Infection
Laval, Quebec, October 30, 2019 – On behalf of the sponsor, Acurx Pharmaceuticals, Altasciences is proud to have successfully completed the clinical conduct, data management, and SAS programming for ACX-362E, a novel, oral antibacterial agent for the treatment of Clostridioides difficile infection (CDI), an acute, serious, potentially life-threatening, intestinal infection. Altasciences efficiently recruited and retained 62 healthy normal subjects for this first-in-human, randomized, double-blind, placebo-controlled, multiple-ascending dose trial, single and multiple ascending dose phase I study to determine the safety, pharmacokinetics, food, and fecal microbiome effects of ACX-362E administered orally to healthy subjects which had a secondary objective to determine the fecal microbiome effects of ACX-362E compared to those of oral vancomycin.
Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for the microbiome aspects of the trial presented the study results at last week’s IDWeek™ Scientific Conference as a “Late-Breaker presentation.” Dr. Garey concluded: "The safety data from the Phase 1 trial are impressive with fecal concentrations comparable to those observed with precedent products that have advanced to demonstrate clinical success. Most notable is the ground-breaking comparison of the effects of ACX-362E versus the standard of care on the normal human gut microbiome. Microbiome analysis demonstrated that ACX-362E has a significantly more favorable effect than oral vancomycin due to less disruption of the microbiota in the gastrointestinal tract. This differential was especially pronounced among the phyla, Bacteroidetes and Firmicutes which generally comprise up to 90% of the healthy human gut microbiome."
The trial, conducted at Altasciences’ clinical pharmacology unit in the U.S.A., provided the first evidence of human safety in single and multiple-ascending doses and a favorable PK profile. Fecal concentrations exceeded those known to inhibit C. difficile several hundred-fold, and blood levels showed low systemic exposure, indicating poor oral absorption as desired to treat CDI.
Angela Phillips, Altasciences’ Senior Director of Clinical Operations said: “We are pleased to have partnered with Acurx Pharmaceuticals to advance a new treatment for this serious, potentially life-threatening, intestinal infection that could change the lives of affected patients. Altasciences’ decades of experience in study participant recruitment and first-in-human trials helped deliver timely results that support the development of effective treatments, such as ACX-362E.”
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, 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
913 304-4505
jcabana@altasciences.com
Outsourcing-Pharma: People on the Move - roundup September ‘19 - P4,P5, By Melissa Fassbender
People on the Move: Outsourcing-Pharma roundup September ‘19
By Melissa Fassbender
Phastar is building up its data science group as AI and machine learning ‘are rapidly modernizing clinical trials’ and Synteract boosts its centers of development in oncology and rare/orphan diseases, among other people on the move this month.
Understanding Vaccines and Immunization - part 2 of a 2-part series
Your Immune System is your Body’s Defense Against Infection (Part 2 of 2)
A Sensitive LC-HRMS Method for the Quantitation of Dystrophin in Human Muscle Tissue
A Multi-Peptide Hybrid LC-MS/MS Assay for the Determination of CTI-1601 in Monkey Tissues Provides Insight into its Disposition and Processing
ISSUE NO. 10 — Tackling Early-Phase Development Challenges with Effective First-in-Human Studies
First-in-Human (FIH) trials in the early phases of drug development represent a critical
milestone in the approval of medicines. Their purpose is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans.
They may also include the collection of data on food or drug interactions, different age groups or gender, proof of concept, and relative bioavailability of different formulations.
In Issue 10 of The Altascientist, we review:
- Designing a FIH trial
- Key aspects of FIH trial designs
- Access to patient populations
- Integrating adaptive designs into FIH trials
- A single-center, randomized, placebo-controlled, double-blind, adaptive, FIH study case study
Designing a First-in-Human Clinical Trial
Unexpected toxicity is the primary reason a drug’s development is halted or terminated. To maximize the probability that a drug will make it from Phase I to market, sponsors need to ensure the preclinical study results obtained are complete and of the highest quality, and that their clinical study design contains all the vital elements to ensure a successful outcome.
When selecting a CRO partner, it is paramount to seek one that can ensure participant safety while prioritizing science and the collection of accurate clinical data. They need the required expertise, a strong project management team, and the operational and technological capabilities to implement adaptive trial designs whenever possible.
Partnering with a CRO such as Altasciences, that has in-depth experience with both preclinical and clinical operations, allows you to work with a single, integrated CRO that can carry your early-phase trials from lead candidate selection to preclinical testing to clinical proof of concept—seamlessly across disciplines, and in the most time- and cost-efficient way possible.
Integrating Adaptive Designs in First-in-Human Clinical Trials
Traditional study designs, particularly in the later stages of drug development, are often criticized for being too rigid, requiring large sample sizes (often thousands of patients), having study timelines that run for years, and costing drug developers millions of dollars until the success or failure rate of the study drug is established. Since 2006, the FDA and EMA have encouraged the development and implementation of adaptive designs to increase trial efficiencies.
Adaptive trial designs are extremely helpful in improving clinical trial efficiency by identifying the optimal dose earlier on, reducing the sample population size, shortening timelines, and getting drugs to market faster, especially in the case of certain therapeutic areas, such as oncology, where failure rates are high.
While conventional trials focus on rapid recruitment and study start up, adaptive trials favor slower patient enrollment as they allow for changes to be made to recruitment based on how the patients are responding to the study drug. By securing specific sub-groups of patients more likely to yield the desired results, and suffer less adverse effects, the overall timeline of the trial can be accelerated.
These flexible trial designs allow researchers to analyze data at interim timepoints throughout the trial, using the results to make adjustments as the study proceeds, to produce a more positive overall outcome.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
Altasciences Welcomes Two New Veterinarians to their Preclinical Team
Laval, Quebec, September 17, 2019 – Altasciences is pleased to be adding Drs. Andrew Gorman and Sylvia West to their team of clinical veterinarians. Both will play key roles in providing clinical care, research, and surgical support, as well as insight into protocol development.
Dr. Gorman has a DVM from VA-MD College of Veterinary Medicine, Blacksburg, VA, and has experience in animal health in veterinary hospitals, emergency, and research settings. In addition to his previous veterinary role at Columbia University, Dr. Gorman was an active participant in the IACUC and contributed to the commissioning of Columbia’s largest vivarium. Dr. Gorman became a diplomate of the American College of Laboratory Animal Medicine in 2018.
Dr. West obtained her DVM from Tuskegee University School of Veterinary Medicine in 2015, and brings experience in small animal medicine and laboratory animal care. She recently completed her training in laboratory animal medicine, in which she was the primary reviewer for IACUC protocols and worked extensively with all laboratory animal species.
“Altasciences’ preclinical services team is driven to offering best-in-class veterinary care, and we are excited to be adding Dr. Gorman and Dr. West to our team. I believe the skills, passion, and energy that they bring to our animal care programs will go a long way to achieving our goals, and deepens Altasciences’ commitment to animal welfare. I personally look forward to working with them,” said Mike Broadhurst, General Manager at Altasciences’ Seattle site.
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, 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
913 304-4505
jcabana@altasciences.com
Top 10 Drug Discovery & Preclinical CROs to watch as we inch closer to Q4 and 2020, Brandon Miller
Altasciences – Private Equity-backed and recent rebranding with digital marketing and media that plays like you’re watching a flick in the theatre, Altasciences is making noise with the vertical integration of its end-to-end capabilities since the acquisition of SNBL USA’s preclinical site in Everett, WA. The company’s leadership comes from a vast background of preclinical, beginning with CTBR – now Charles River. We’ve seen this approach before, but for some reason (I think much of it is company culture and leadership oriented / familiarity with preclinical AND clinical) Altasciences looks to have the winning formula. It will also be interesting to watch their strategic partnership with WuXi and how it impacts pulling preclinical programs into the clinic.
Clinical Case Study - First in Human