Midatech Pharma Plc (LON:MTPH, NASDAQ:MTP) said it had been given the green light by Polish regulators for an EU first-in-human study for Q-Octreotide, also known as MTD201.
It has been provided verbal confirmation; formal written approval is expected within the next two weeks.
MTD201 is being developed to treat carcinoid cancer and a hormonal disorder caller acromegaly.
Sustained release technology
Based on the company’s Q-Sphera sustained release technology, Midatech’s innovation is being developed as the first alternative version of the commercial leading product, Sandostatin.
This potentially pivotal study comprises an initial exploratory phase which is expected to be completed by the middle of the year, with the final confirmatory portion to be concluded in the second-half of 2018.
The speciality pharma group said decision to take MTD201 to commercial scale will be taken following the interim data. Assuming positive the clinical output is positive, a product could be launched as early as 2020.
"This is a major milestone for Midatech and we are pleased to start dosing in subjects soon,” said chief executive, Dr Jim Phillips of the Polish approval.
“We have seen compelling data for MTD201 in pre-clinical models and we are excited by the potential for this to be evidenced in patients as well.
“This trial will provide useful data not only for MTD201, which is one of our top three priority programmes, but also for our sustained release technology platform that is being evaluated for follow-on products."