Cambridge, UK, 20th June 2023 – TRx Biosciences today announces favourable safety and pharmacokinetic data from a single-part, five-period, sequential, open-labelled Phase 1 study of OXL001, a novel treatment for cancer under development by Oxilio Limited, which leverages TRx’s oral targeted delivery technology.

Oxilio has today confirmed that the objectives of the study, conducted at Quotient Sciences, were met as follows:

  • OXL001 capsules were considered to be safe at all doses tested
  • Dose proportional plasma exposures were achieved via a novel lipidic formulation technology, exclusively licenced from TRx Biosciences
  • Data generated will inform the formulation and dosing strategy for future OXL001 studies

Oxilio and TRx also announce the commencement of an additional pre-clinical programme that will enhance understanding of how OXL001 formulations can target preferential uptake into specific tumour-surrogate tissues following oral delivery. Results in the coming months will enable further optimisation of OXL001 at this stage of clinical development to maximise the product’s potential in the treatment of cancer.

Dr Simon Yaxley, Director of Oxilio Limited, said:

“We are very excited with the results of our first human study using our novel lipid-based aprepitant formulation, which allow us to plan the advancement of our lead OXL001 product into Phase 2 studies for the treatment of cancer. OXL001 represents a product opportunity with immense potential benefit to thousands of patients and the dose proportional exposures achieved represent a tremendous breakthrough towards that objective. We would also like to thank our development partners, TRx Biosciences Limited and Quotient Sciences. TRx Biosciences has provided invaluable support in getting us to this exciting point in development and, together, we have been able to leverage Quotient Sciences’ Translational Pharmaceutics® platform to gain rapid access to the clinic, helping deliver these favourable results in a smooth and rapid fashion.”

Dr Mark Egerton, CEO of Quotient Sciences, added:

“We are pleased that the Phase 1 healthy volunteer study being conducted at Quotient Sciences’ Nottingham facility has delivered rapid and favourable results for Oxilio’s OXL001 program. We will continue supporting OXL001 with our Translational Pharmaceutics® platform with fully integrated clinical assessments in order to aid in accelerated development timelines and downstream advancement to patients.”

Dr Robin Bannister, CEO of TRx Biosciences, added:

“Technology under development by TRx has the potential to transform the treatment of cancer. We are delighted to have partnered with Oxilio on its OXL001 programme and to have translated TRx technology into clinic in this first study. Oxilio have shown immense commitment and courage towards the development of new treatments for cancer and we are very excited for the future of our collaboration, which will retain TRx’s full support.”

 

About Oxilio

Oxilio is a pioneering pharmaceutical drug development company improving cancer treatment through rapid, cost-effective drug development. Our mission is to identify, repurpose, and commercialize existing drugs to address unmet needs in cancer therapy. We find new uses for old drugs, a proven approach that involves less risk, time, and cost to bring a drug to the marketplace. Through repurposing, reformulation, and gold-standard modelling and simulations, we are fast-tracking disruptive drug development at speed and at low cost.

For more information, please visit oxilio.co.uk

Company Contact: info@oxilio.co.uk

  

About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs 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 solutions, fast.

For more information, please visit quotientsciences.com

Company Contact: Kimberly Burrell – Executive Director of Global Marketing (509) 910-1551 Kimberly.Burrell@QuotientSciences.com

 

About TRx Biosciences

TRx Biosciences’ technology enables targeted oral drug delivery to specific organs, cells and tissues in cancer, CNS and respiratory diseases, and diseases of the immune system using a clinically and commercially proven approach. Our bio-enabling delivery mechanism addresses bioavailability, solubility and permeability limitations simultaneously, whilst allowing drugs to be highly targeted towards specific cells and tissues to best leverage their pharmacology. Our data demonstrates that TRx technology has the potential to significantly enhance the design and development of existing and future small molecule-based therapies.

For more information, please visit trxbiosciences.com

Company Contact: dan.gooding@trxbiosciences.com