UK-based specialist pharmaceutical firm Midatech Pharma has submitted a clinical trial application (CTA) for its drug candidate MTD201 to treat carcinoid cancer and acromegaly.
Utilising the firm’s sustained release platform, MTD201 is designed to deliver a long-acting dose of a somatostatin analogue called octreotide that is being developed as an alternative treatment to existing Sandostatin LAR (SLAR).
MTD201 is manufactured using Midatech’s Q-Sphera microsphere platform with micro-fluidic technology to obtain a precision sustained release particle formulation.
The new trial is planned to establish that MTD201 can be interchanged pharmacokinetically and / or pharmacodynamically and by extrapolation with SLAR.
Additionally, the trial aims to validate that MTD201 will achieve equivalent therapeutic control of growth hormone, while providing an alternative to SLAR in active acromegaly patients.
Midatech Pharma CEO Dr Jim Phillips said: “MTD201 will provide a much-needed addition to currently available therapies for the treatment of carcinoid cancer and acromegaly.
“This clinical trial is the culmination of more than five years of development and is a key value inflection point for our proprietary sustained release technology platform as it moves into the clinic for the first time on track for Q4 2017.”
The MTD201 clinical programme is expected to be initiated in the fourth quarter of this year and is scheduled to be completed in the first half of next year.
It is anticipated that in comparison to SLAR, MTD201 will feature fast and simple reconstitution with less errors and wastage, decreased pain on injection due to use of small syringe needle and volume, and improved economics.