20th Sep 2019 13:30
(Alliance News) - Midatech Pharma PLC on Friday said it has received approval to start a first phase of study on MTD201, which it is developing for the treatment of acromegaly and neuroendocrine tumours.
The biotechnology company said the objective of this study is to investigate subcutaneous administration as an additional injection route, compared to intramuscular administration.
The data from the study is expected to become available towards the end of 2019 or early in 2020.
The earlier study, which was conducted in 2018, demonstrated MTD201 to have a favourable long-acting clinical profile with significantly lower variability in release kinetics, and no initial burst release of the active ingredient, when compared to Novartis AG's Sandostatin LAR.
Looking ahead, Midatech Pharma said it believes MTD201 is well positioned as a next generation long-acting agent in the somatostatin analogue market.
Preparation for the next pivotal phase of clinical development for MTD201 in 2020 is also underway, the company noted. Following confirmation of the MTD201 administration route from this first-phase study, the pivotal registration study in acromegaly patients is planned to commence early in 2020.
"We are very pleased to have received approval to start this the first phase study which we believe will demonstrate the clear advantages of the MTD201 product utilising our Q-Sphera technology," said Chief Executive Craig Cook.
Midatech shares were trading 7.7% higher in London on Friday at 5.79 pence each.
Related Shares:
MTPH.L