Full Press Release Details
("Midatech" or the "Company")
Positive results from MTD201-102 Study
Supports Subcutaneous Route for Long-Acting Octreotide Product
Midatech Pharma PLC (AIM: MTPH.L; Nasdaq:
MTP), an R&D biotechnology company focused on delivering innovative oncology and rare disease products to patients, is pleased
to announce positive headline results from Study 102. The study met its primary endpoints to confirm similar pharmacokinetics and
bioavailability of octreotide for subcutaneous and intramuscular routes of administration.
The results demonstrate that MTD201 can
deliver sustained plasma octreotide concentrations within the range needed for therapeutic efficacy with an injection interval
of six to eight weeks by either subcutaneous or intramuscular administration.
These are key advantages for patients,
payors and physicians over the current standard of care. The subcutaneous route of administration is simpler, less painful, and
allows the potential for self-administration at home, with less need for hospital visits or nurse supervision to receive treatment.
An extended dose interval would reduce the annual treatment burden for patients from 12 to just 6 injections per year, thus providing
a much less frequent, more cost effective and patient friendly treatment regimen. These attributes are in addition to already demonstrated
advantages for MTD201, including less painful injections due to smaller needle size (21 gauge needle, compared to 19/18 gauge for
SLAR), simpler, more reliable reconstitution and injection (less than 10 minutes versus up to 40 minutes for SLAR), and flexibility
for unit doses above 30mg.
Study 102 investigated the subcutaneous
administration of MTD201 as an additional alternative injection route to intramuscular administration, and determined the preferred
administration route to take forward into the MTD201 registration study to be commenced in mid 2020. The primary endpoints were
to determine the relative plasma octreotide bioavailability and pharmacokinetics of MTD201 deep subcutaneous injection, MTD201
deep intramuscular injection and Sandostatin Octreotide Acetate Injection deep subcutaneous injection. The study was conducted
in 28 healthy subjects and following a single injection of MTD201 (either subcutaneously or intramuscularly) in early October 2019,
all subjects entered a 63-day observation and sampling period to determine plasma octreotide and insulin-like growth factor-1 (IGF-1)
The key preliminary results from Study
Preparation for commencement of the next
pivotal study for the clinical development for MTD201 is now underway, which is planned to commence later in H1 2020. A pivotal
registration programme to support a second indication in NET is also expected to commence in 2020.
Commenting Craig Cook, CEO of Midatech,
said: "We are very pleased with the positive results of Study 102. It confirmed both the subcutaneous dosing route for
MTD201, as well as the potential for extended dosing intervals. These are key advantages for patients, physicians and payors, being
the first therapy to offer this, and also gives Midatech a competitive advantage versus others as we move the product through to
potential approval."
For more information, please contact:
| Midatech Pharma PLC |
| Dr Craig Cook, CEO Stephen Stamp, CFO |
| Tel: +44 (0)1235 888300 |
| www.midatechpharma.com |
| Panmure Gordon (UK) Limited (Nominated Adviser and Broker) |
| Freddy Crossley, Emma Earl (Corporate Finance) |
| James Stearns (Corporate Broking) |
| Tel: +44 (0)20 7886 2500 |
| IFC Advisory Limited (Financial PR and UK Investor Relations) |
| Tim Metcalfe / Graham Herring |
| Tel: +44 (0)20 3934 6630 |
| Email: midatech@investor-focus.co.uk |
| Edison Group (US Investor Relations) Joseph Green/ Laine Yonker (646) 653-7030/ 7035 jgreen@edisongroup.com/ lyonker@edisongroup.com |
contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
Midatech Pharma PLC (dual listed on LSE
AIM: MTPH; and NASDAQ: MTP) is an R&D company focused on Making Medicines Better' by improving delivery of drugs
in the body. The Company combines existing medications with its proprietary and innovative drug delivery technologies to provide
compelling oncology and rare disease products that have the potential to powerfully impact the lives of patients undergoing treatment
for life threatening diseases.
The Company has developed three in-house
technology platforms, each with its own unique mechanism to improve delivery of medications to sites of disease. All of the Company's
technologies have successfully entered human use in the clinic, providing important validation of the potential for each platform:
By improving biodelivery and biodistribution
of approved existing molecules, Midatech's unique R&D has the potential to make medicines better, lower technical risks,
accelerate regulatory approval and route to market, and provide newly patentable products. The platform nature of the technologies
allows the potential to develop multiple drug assets rather than being reliant on a limited number of programmes.
Midatech's headquarters and R&D facility
is in Cardiff, UK, and manufacturing operation in Bilbao, Spain. For more information please visit www.midatechpharma.com
in this press release may constitute "forward-looking statements" within the meaning of legislation in the United Kingdom
and/or United States Private Securities Litigation Reform Act. All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding
the potential treatment options for MTD201 and the development of the programme.
be made to those documents that Midatech shall file from time to time or announcements that may be made by Midatech in accordance
with the London Stock Exchange AIM Rules for Companies ("AIM Rules"), the Disclosure and Transparency Rules ("DTRs")
and the rules and regulations promulgated by the US Securities and Exchange Commission, which contains and identifies other important
factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements.
These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking
statements by or concerning Midatech are expressly qualified in their entirety by the cautionary statements above. Except as may
be required under the AIM Rules or the DTRs or by relevant law in the United Kingdom or the United States, Midatech does not undertake
any obligation to publicly update or revise any forward-looking statements because of new information, future events or otherwise