MedPage Today: Amylin Analogue Plus Semaglutide Get Early Win for Weight Loss
Altasciences Initiates Phase I Study in Healthy Normal Subjects for ST-2427, a Non-Opioid Analgesic for Acute Pain
Laval, Quebec, May 13, 2021 – Altasciences is pleased to support SiteOne Therapeutics with a Phase I, randomized, double-blind, placebo-controlled study in healthy adults to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. ST-2427 is a highly selective inhibitor of NaV1.7 for the management of moderate-to-severe pain; by selectively targeting NaV1.7, ST-2427 aims to stop the electrical signals responsible for pain before they reach the central nervous system.
Amy Denvir, General Manager of Altasciences’ Kansas City clinical site, says, “We are proud to partner with SiteOne Therapeutics and help move this important therapeutic into clinical trials. Helping bring to market a new approach that may provide a non-opioid option to treat moderate to severe pain is an exciting prospect, and we look forward to delivering this ground-breaking research.”
Click here to read the SiteOne press release.
Altasciences has designed and conducted hundreds of first-in-human trials by offering comprehensive, full service, early development solutions. With a focus on developing sound strategies combined with operational efficiencies, the company minimizes the time taken to make critical go/no-go decisions by harmonizing clinical pharmacology services, biomarker capabilities, PK/PD analysis expertise, and program knowledge.
About Altasciences
Altasciences is an integrated drug development solution company 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
Effect of Difelikefalin, a Selective Kappa Opioid Receptor Agonist, on Respiratory Depression: A Randomized, Double-Blind, Placebo-Controlled Trial
Altasciences Acquires Calvert Laboratories
Laval, Quebec, May 5, 2021 — Altasciences, a forward-thinking CRO/CDMO supporting all crucial steps in early-stage drug development, from lead candidate selection to clinical proof of concept, announced today that they have completed the acquisition of Calvert Laboratories, a preclinical CRO located on the U.S.A.’s East Coast. This acquisition will complement Altasciences’ current preclinical West Coast operations, located just north of Seattle, WA. For more than 40 years, Calvert Laboratories has been working with clients to help develop the next generation of therapeutics aimed at extending and improving human life; in line with Altasciences’ focus on getting better drugs to the people who need them faster.
“This acquisition will increase small molecule expertise as well as add efficacy pharmacology, ophthalmology, and carcinogenicity study capabilities, to Altasciences’ current preclinical offering. Furthermore, it expands Altasciences’ presence on the East Coast, and the site is conveniently located in close proximity to our CDMO facility,” added Steve Mason, Co-Chief Operating Officer at Altasciences.
Calvert Laboratories has a long track record in the industry as a collaborative development partner bringing extensive experience, an innovative solutions-oriented approach, and unsurpassed performance to preclinical drug development programs. “The entire team at Calvert Laboratories is very excited to join the Altasciences family,” said Michael A. Recny, Ph.D., outgoing Chief Executive Officer of Calvert Laboratories. “The Company can now offer our clients an expanded suite of preclinical and clinical services by leveraging the broad capabilities of a larger and more diversified global CRO.”
“This acquisition is an integral part of Altasciences’ strategic growth plan to provide a comprehensive, fully integrated early phase drug development solution, while addressing the ever-changing outsourcing challenges of biopharmaceutical companies across the globe,” explained Chris Perkin, CEO at Altasciences. “We look forward to working side by side with our new team of preclinical experts on the East Coast, a team that shares our values for excellence, integrity, and customer focus,” concluded Chris Perkin.
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
ISSUE NO. 17 — Maximizing Drug Formulation for First-in-Human Trials
The main objective of first-in-human (FIH) trials is to determine the starting dose of a new drug, one that is low enough to provide minimal to no safety and toxicity risks and allows the highest dosage/benefit for the intended trial.
The manufacture of the drug product for clinical trials is of critical importance, as the formulation, manufacturing, and assessment of a drug candidate during FIH trials can be contributing factors in whether the drug safely provides the correct dosage and, ultimately, gains regulatory approval. Decisions made during early phase development, when the compound is being used in a clinical research setting, provide significant learnings for its progression through later phase research. Integration is key — ensuring that information gathered at the clinic is efficiently incorporated into the manufacturing process is a major contributor to the goal of achieving marketing approval.
In Issue 17 of The Altascientist, we review:
- the role of formulation in drug development
- the impact of formulation on subject safety
- meeting regulatory requirements
- Pharmacy case study: Supporting Regulatory Approval
- Manufacturing case study: Mission Impossible to Possible
The Importance of Drug Formulation in First-in-Human Trials
The first step on the pathway to FIH clinical trials is formulation development. Generally, it is advisable to develop a dosage form that can be produced efficiently and cost effectively, to established quality specifications; simpler dosage forms like oral liquids, powders, tablets, or capsules are favored. Among the favored dosage forms, there are advantages and disadvantages to each. For example, tablets can have a longer shelf life and can accommodate a higher dose of active ingredient than capsules, while capsules are fast acting and can provide a higher drug absorption rate. Some advanced drug delivery systems, such as nanoparticles, require more complex formulations and manufacturing processes, and thus involve increased manufacturing costs, particularly in later development stages and commercialization.
Many of the drugs that enter development fail, even if they make it through FIH studies. Some of the high attrition rate can be attributed to the fact that key performance characteristics — such as solubility and bioavailability — are easily achieved in simple FIH formulations but challenging to replicate in more complex dosage forms for late-stage trials and commercial use. When creating a FIH formulation, it is important to keep in mind the rigors of later stage development and eventual market availability.
The Impact of Drug Formulation on Subject Safety in First-in-Human Trials
Subject safety is always a primary concern in planning clinical studies, and particularly with novel drug products entering FIH trials. The use of single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as the employment of adaptive protocols and sentinel dosing are part of the established safety protocols for Phase I studies.
If the candidate drug is considered high risk based on data from preclinical trials, it is preferable to formulate for intravenous administration. A slow intravenous infusion can easily be stopped if serious/severe adverse reactions occur. Likewise, dose escalation needs to be considered during manufacturing to fit the planned dose levels in the FIH study and the data gathered from sentinel dosing. If adjustments are needed based on data from the initial dose plan between cohorts, it is important to be prepared with a plan to titrate dosage, or reformulate the product to ensure maximum effectiveness with minimal safety concerns.
How Altasciences Can Help With Drug Formulation for Your First-in-Human Trials
Significant benefits can be realized with Altasciences’ Proactive Drug Development approach of integrating Good Manufacturing Practice (GMP) manufacturing and clinical testing. Shorter timelines, reduced costs, and improved flexibility are achieved with real-time drug product manufacture, as the development team can evaluate and optimize new formulations in the clinic, based on human data. When clinical trial teams work closely with those involved in formulation and manufacturing process development, collaboration and data sharing minimize risk and help reduce delays. Product development can be started when a quality active pharmaceutical ingredient (API) is ready, the clinical study can start as soon as regulatory approvals are received, and the product is released.
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