The clinical equivalence study is being conducted in 24 healthy subjects in a double-blind, randomised, parallel group protocol to evaluate the interchangeability between Q-Octreotide and the reference product, Sandostatin LAR ("SLAR"), following single dose administration.
The aim is to establish equivalence of Q-Octreotide with SLAR, and to show that it can achieve safe and effective growth hormone levels in patients.
The Company expects data for this study to be available in the second half of 2018 and intends to expand the study into a pivotal registration study, of similar design in up to 100 subjects, to complete in the first half of 2019.
The Company is seeking the same marketing product label indications as SLAR. Moreover, the Company plans to highlight the potential advantages of Q-Octreotide with prescribers and regulators.
These advantages, made possible by Midatech's novel sustained release microsphere (Q-Sphera) technology, include: improved speed and simplicity of reconstitution along with fewer errors, a less painful injection with fewer blockages, minimal wastage with fewer repeat injections and errors, and improved economics.
Pending positive clinical data showing equivalence and completion of commercial scale manufacture requirements, the Company expects to file for marketing authorisation with the U.S. Food and Drug Administration (FDA) in 2020. The Company believes Q-Octreotide could capture up to 5% of the $2 billion annual market for SLAR.
Midatech CEO-designate Craig Cook said: "We are pleased to initiate this key study for one of our core programmes in oncology, MTD201, which also represents an important milestone for our sustained release Q-Sphera technology and its potential use in future products.
“Having resolved important manufacturing challenges and requirements, and incorporated invaluable regulatory authority feedback into the program design, we are confident that we have a robust study which will provide meaningful data on MTD201 in the second half of this year.
“Our pre-clinical data so far illustrates the interchangeability as well as numerous benefits of Q-Octreotide as a therapy for the debilitating and lethal diseases of carcinoid cancer and acromegaly versus the standard of care. We are working hard to bring this product to market to offer patients, physicians and payors an alternative choice for treating these diseases."
Source: Company Press Release.