Midatech submits clinical trial application for MTD201

International speciality pharmaceutical company Midatech Pharma announced the submission of a clinical trial application for a first in human study of its MTD201 programme in carcinoid cancer and acromegaly.

The AIM-traded firm said it expected to enter the clinic in the fourth quarter, pending the regulatory approval to conduct the clinical trial which is expected shortly.

It said the “indolent and rare hormone” tumour diseases caused “debilitating” morbidity and mortality for patients, and it was anticipated that MTD201 would provide a much-needed addition to the choice of therapies available to patients, physicians, and payors.

MTD201 used Midatech's sustained-release platform to produce a long-acting dose of octreotide, a somatostatin analogue treatment for the tumours, being developed as an alternative version of the commercially available product Sandostatin LAR (SLAR).

The market for octreotide was estimated to be worth $2bn globally.

“MTD201 will provide a much-needed addition to currently available therapies for the treatment of carcinoid cancer and acromegaly,” said Midatech chief executive officer Dr Jim Phillips.

“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.

“We have seen compelling data for MTD201 in preclinical models, and we are excited by the potential for this to be evidenced in patients as well.”

MTD201 is manufactured using Midatech's proprietary ‘Q-Sphera’ microsphere platform, the company’s board explained, which used microfluidic technology to produce a precision sustained release particle formulation.

The study aimed to establish that MTD201 is interchangeable with SLAR pharmacokinetically and/or pharmacodynamically and, by extrapolation, that it would achieve equivalent therapeutic control of growth hormone while providing an alternative to SLAR in patients with active acromegaly.

Midatech said the study was expected to complete in the first half of 2018.

It said the potential benefits of MTD201 against SLAR included interchangeability, faster and simpler reconstitution with fewer errors and less wastage, reduced pain on injection due to a smaller syringe needle and volume injected, and improved economics.