The AIM-listed firm said it planned to develop MTD201 as a new product for the treatment of acromegaly, where the body produces too much growth hormone, and neuroendocrine tumours (NET), which affect hormone-releasing cells and can sometimes be cancerous.
Midatech said in a 2018 phase 1 exploratory study MTD201 had delivered favourably when compared to the market-leading Sandostatin LAR (SLAR), developed by Swiss pharma firm Novartis.
Additional advantages demonstrated in the study included smaller, less painful needle sizes, simpler and error free injection, quicker bedside reconstitution (taking less than 10 minutes versus up to 40 minutes for SLAR), reduced wastage and significantly lower manufacturing costs.
Midatech also said the group’s Q-Sphera drug delivery platform offered a “significant competitive advantage”.
The company said it expected other competitive advantages to be leveraged for MTD201 including longer dosing intervals and the ability to inject higher doses and reduce the need for multiple injections.
Going forward, Midatech said the next phase of development was scheduled for the second half of 2019, while a pivotal registration study in acromegaly patients to compare MTD201 with a placebo was planned to begin in early 2020 following approval by regulators.
The pivotal study was expected to conclude in 2021, and subject to a successful outcome and commercial scale-up at the company’s manufacturing facility in Bilbao Midatech planned to submit marketing authorisation applications that same year.
Subject to funding, a pivotal registration programme for NET was also expected to begin in the first half of 2020.
“We are delighted to be able to lay out our roadmap to bring MTD201 to market. Building on the exciting Phase I data and further leveraging the full potential of the Q-Sphera differentiating technology promises a compelling product opportunity for MTD201”, said Dr Craig Cook, Midatech’s chief executive.
“The development path has been finalised in close collaboration with our distinguished advisory board, and we believe we have a clear path to potential commercialisation”, he added.
In early trading on Thursday the shares were up 1.6% at 6.4p.