Summary: At the European Pediatric Formulation Initiative (EuPFI) conference in 2023, Quotient Sciences partnered with Ardelyx, Inc. to present a collaborative study exploring the palatability of oral tenapanor formulations intended for pediatric use.

Titled “Taste Assessment Study of Tenapanor Pediatric Solution Formulations”, the poster was authored by a team that included Amit Sawant, Marcello DiMare, David Matusow, Susan Edelstein, Somasekhar Menakuru, and Vanessa Zann.

Read highlights from the poster below and download the poster to see additional findings.   

Objectives of the clinical study

Tenapanor is a minimally absorbed sodium hydrogen exchanger (NHE3) inhibitor, approved in tablet form (IBSRELA®) for treating irritable bowel syndrome with constipation (IBS-C) in adults.  

Ardelyx looked to develop an oral solution formulation to extend the therapeutic benefits of tenapanor to children aged 2–18, partnering with Quotient Sciences for pediatric formulation development and clinical taste assessment. The primary goal of the taste study was to evaluate taste acceptability of various formulations. A secondary objective was to assess specific taste attributes including sweetness, bitterness, and aftertaste.  

Study design and methodology

The study looked to successfully identify the most palatable formulation for pediatric patients, accomplished through enrolling 14 healthy adult volunteers to participate in a controlled, randomized, “sip and spit” taste assessment. The study was conducted from Quotient Sciences – Nottingham, UK facility.  

Each participant evaluated seven different tenapanor formulations, each containing 5 mg/mL of the active ingredient along with different sweeteners  (sorbitol and sucralose) and flavors (strawberry and raspberry).

Participants then were asked to rate each formulation on a 9-point Likert scale for seven taste attributes, including overall acceptability, sweetness, and flavor. Quotient Sciences collected and analyzed the data to determine which formulation offered the best sensory profile.

Conclusions

The study concluded that formulations containing sucralose, sorbitol, or raspberry flavor—individually or in combination—are suitable candidates for further development in pediatric clinical studies.

Specifically, Regimen G, a combination of sucralose and raspberry flavor, achieved the highest scores across all taste attributes, showing a 2.0-point improvement in overall acceptability compared to the unsweetened/unflavored reference formulation.  

Both sucralose and sorbitol improved taste acceptability when used alone, and the addition of raspberry flavor significantly enhanced the sensory experience. 

Download the poster

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Summary: At our recent event in Garnet Valley, PA., our team presented a poster titled “Use of ASAPprime® in a Pharmaceutical CDMO Space”, showcasing how stability assessment with advanced predictive stability assessment tools helps accelerate drug development timelines.

Poster authors Kyle Frey, Helen Baker, and Brad Rowe highlighted the impact of ASAPprime® modeling in a contract development and manufacturing organization (CDMO) setting.

Read highlights from the poster below and download the poster to see additional findings.   

How does ASAPprime® work?

Traditional ICH stability studies can take months or even years to yield actionable data. ASAPprime® offers a smarter, faster alternative—delivering precise long-term stability predictions in as little as 28 days.  

The poster detailed how ASAPprime® has been successfully applied across all development phases—from early formulation screening to post-registration and lifecycle management activities.  

Key applications of ASAPprime® include:

• Early identification of stability risks
• Comparative shelf-life analysis
• Packaging optimization (e.g., validating removal of desiccants without compromising stability)
• Mechanistic understanding of degradation pathways
• Support for regulatory submissions with FDA-accepted data

Why it matters: Real applications and benefits of ASAPprime®  

In a competitive pharmaceutical landscape, speed and precision are critical. ASAPprime® empowers development teams to make informed decisions faster, reduce unnecessary testing, and ensure product viability from benchtop to patient.  

As a CDMO using ASAPprime®, we have been able to provide reliable, data-driven insights to support investment decisions:

Predicting 1-year shelf life (subsequently verified by real-time stability data) for various oral liquid, immediate-release tablets, and modified-release tablet formulations

Demonstrating that a novel formulation was three-times more stable than a marketed product of the same active pharmaceutical ingredient

Optimizing packaging configurations for cost savings  

This approach is not one-size-fits-all: each study is tailored to the drug program, ensuring relevance and reliability throughout the development lifecycle.

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Note: Our accelerated stability assessment services utilize the ASAPprime® stability assessment software licensed from FreeThink Technologies, Inc.

YourChoice Therapeutics has announced the publication of a peer-reviewed paper in Communications Medicine, a Nature Portfolio Journal. The new manuscript details findings from the Phase 1a study of YCT-529, a hormone-free male birth control pill, conducted by Quotient Sciences.

Following successful preclinical studies, the Phase 1a study began at Quotient Sciences' Nottingham, UK facility in December 2023 to assess single doses of YCT-529 in 16 male volunteers. The study concluded in June 2024 with no observed impact on heart rate, blood parameters, testosterone levels, sexual desire, or mood.

YCT-529 is a retinoic acid receptor-alpha (RAR-α) antagonist designed to be a first-in-class, hormone-free, orally administered male contraceptive. Positive results from the Phase 1a clinical study supported the candidate’s follow up Phase 1b study, currently being conducted in New Zealand by NZCR.

A 2024 study published in Andrology (Wiley) showed strong global interest in novel male contraceptives, with 61% of men willing to try them and high levels of trust from female partners. Preferences were driven primarily by the method of administration and timing of use, highlighting significant potential for expanding male contraceptive options to meet unmet needs. 

YCT-529 is on track to be the first, non-permanent contraceptive option for men in well-over a century, providing a potentially transformative healthcare choice in an area where innovation has been overdue. 

The manuscript, “Safety and Pharmacokinetics of the Non-Hormonal Male Contraceptive YCT-529,” is now available through Communications Medicine.

Quotient Sciences Featured as part of MMV Annual Report

According to the World Health Organization, in 2022, there were 249 million malaria cases and 608,000 deaths globally with sub-Saharan Africa bearing 95% of this burden. Innovations in malaria prevention are essential to respond to this ongoing public health crisis. 

Medicines for Malaria Venture (MMV) and Quotient Sciences have begun the first clinical trial for a long-acting injectable (LAI) preventive compound for malaria. The trial, conducted in healthy volunteers in Nottingham, UK, marks a significant step toward preventing malaria in endemic regions.

In the trial for MMV371, a derivative of atovaquone—approved as part of atovaquone-proguanil (Malarone®), a medicine widely used by travellers to malaria-endemic areas—is being tested in an injectable form that could provide up to 3 months of protection with a single intramuscular dose.

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The trial is evaluating the drug’s safety, tolerability and pharmacokinetics, or how the body interacts with the medicine. The final injectable medicine will be a fixed-dose combination of MMV371 and a suitable partner drug — a strategy that reduces the likelihood of inducing resistant strains of malaria parasites. 

The study is evaluating different dose levels of MMV371 in adult volunteers. If approved, this new product could potentially play a key role in protecting against new infections from all malaria parasite species, including the two most common strains, Plasmodium vivax and Plasmodium falciparum, the most deadly form of malaria.

Dr. Nand Singh, Medical Director, says, "...this could be a game-changer for malaria. If successful, LAIs will support malaria eradication through prevention, cure and elimination - a significant milestone not only in drug delivery, but in fighting a disease that has impacted millions for far too long. I am confident that this technology will put endemic regions at the forefront of improving global health outcomes."

Learn more in the MMV 2024 Annual Report here.

NOTTINGHAM, UK – September 2, 2025 – Quotient Sciences, a leading global drug development and manufacturing accelerator, and UK technology innovation centre, CPI, have signed a memorandum of understanding (MoU) to form a Joint Venture (JV) aimed at accelerating the development of RNA-based therapies.

The JV will combine Quotient Sciences’ Translational Pharmaceutics® platform with CPI’s expertise in small scale manufacture of RNA and LNP encapsulation to deliver a first-of-its-kind, integrated offering for the development of mRNA drug products. The JV will address the growing industry demand for agile solutions that bring new RNA therapeutics to patients with greater speed and confidence.

“This is a pivotal moment for RNA drug development,” said Thierry Van Nieuwenhove, CEO at Quotient Sciences. “The combined innovation and deep technical expertise of Quotient and CPI will enable developers to benefit from a vastly accelerated supply chain, with clinical batches going from plasmid to clinical dose in as little as two months. This offers a highly streamlined pathway to early-phase clinical trials for mRNA drug candidates”.

The JV will integrate mRNA synthesis, LNP formulation development, clinical manufacturing, and early-phase clinical testing, all under one collaborative framework. The ability to quickly transition from DNA to RNA and into clinical trials will not only shorten timelines but also greatly increase the chances of clinical success, by affording drug developers the ability to adjust dose and formulation parameters based real-time clinical data from healthy human volunteers. This approach offers clear advantages in modalities where drug delivery is key to efficacy.

Frank Millar, CEO at CPI, added: “We’re proud to be partnering with Quotient Sciences on this initiative which represents a bold step forward for the RNA ecosystem. Our shared vision is to enable scalable and sustainable development pathways for mRNA therapies that meet global health challenges head-on.”

Translational Pharmaceutics® has been used globally by biotech and large pharma on over 500 programs with small molecule and peptide drug candidates. This JV extends the application of Translational Pharmaceutics into mRNA-based therapeutics.

Details of the joint venture including name, branding, and operational roadmap will be announced as the collaboration progresses.
 

ENDS

About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programmes and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast, because humanity needs novel therapeutic solutions, fast. Quotient Sciences has been recognized as a multi-year winner of the CRO Leadership Awards in 2021, 2022, and 2024 and of the CDMO Leadership Awards in 2023.  

For press enquiries, contact:

Erica Fearnley
Executive Director, Strategic Marketing at Quotient Sciences
[email protected] 

Rachael Heath
Senior PR Manager at ramarketing (on behalf of Quotient Sciences)
[email protected]

About CPI

CPI is an independent technology innovation centre and a founding member of the UK Government’s High Value Manufacturing Catapult. Since 2004, CPI has helped organisations bring innovative ideas to market by reducing the risks and costs associated with R&D. Through collaboration with partners across academia, industry, and government, CPI supports the development of next-generation medicines and technologies. Learn more at www.uk-cpi.com 

For press enquiries, contact:

Becky Fields
Corporate Communications Manager at CPI
[email protected]