In my article listing the somatostatin analogues and their drug delivery systems pipeline (click here), there has been a very interesting development in a product called Q-Sphera (was previously known as Q-Octreotide).  In a press release, it was announced that an unnamed ‘pharma giant’ has signed a deal with Midatech Pharma Plc that will see it evaluate the latter’s Q-Sphera drug delivery platform.  Later in Feb 2019, the pharma was identified as China Medical System Holdings Limited (based out of Hong Kong).  Adding to the excitement behind this development, it was announced in Mar 2019 that the Spanish Government had conditionally approved a €6.6m loan that will be used to help commercialise this flagship drug.

Latest update 8th January 2020. 

Midatech Pharma PLC has hailed the positive results from a study assessing the potential to deliver one of its drugs via an injection under the skin rather than into the muscle. MTD201, which is being developed to treat Neuroendocrine Cancer and the growth hormone condition Acromegaly, was able to maintain the correct levels of plasma octreotide over six to eight weeks using this subcutaneous method, researchers found. The extended timeframe provides MTD201 with an advantage over the current injections into the muscle, which last just four weeks. Speaking about the results of Study 102, Midatech chief executive Craig Cook said: “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.” The clinical assessment of the delivery mechanism for MTD201 confirmed the process was safe with a similar profile to the jab into the muscle tissue. The ability to cut the injection burden to six from 12 a year would save time and money and allows the potential for self-administration, Midatech said. MTD201 has already been shown to require a smaller gauge needle, which makes delivery less painful to administer, while the treatment itself is quick to make up too. A ‘pivotal’ study if MTD201 is planned for later in the first half with preparations already underway.

Midatech’s Q-Sphera™ is an advanced microencapsulation and polymer-depot sustained release (SR) drug delivery platform produced using a novel and disruptive printing based process, with numerous and distinct advantages over conventional reactor based technologies. From a manufacturing perspective Q-Sphera™ is a precise, scalable, efficient, and environmentally friendly microparticle platform. From a clinical perspective Q-Sphera™ ensures monodispersed microparticles that release active drug compounds into the body in a superior linear tightly controlled and predictable manner.

What are the main differences?

The current trials are based on the use of Sandostatin LAR (Octreotide) using the Q-Sphera delivery system (previously known as Q-Octreotide). The key aspects of usability are reconstitution and needle size but there is also an inference that less frequent injections could be possible.   A comparison of the trial output is as follows:

• Reconstitution: For Sandostatin LAR (SLAR)™ the procedure to prepare the product for injection is a complex 30 step error prone process, taking up to 40 minutes and, once reconstituted, the product has to be given immediately to prevent solidifying and wastage of the injection. For MTD201™ Q-Octreotide the preparation process is a simple 5 – 7 minute procedure, after which the product is stable up to 2 hours. For the nurse preparing and giving the injection, the short and flexible process of MTD201™ has clear advantages over the all consuming SLAR process™.
• Needle size: For SLAR, a large 19G needle is prescribed for the injection to prevent blockage, and often an even large 18G needle is required for successful injection. For MTD201 Q-Octreotide the precision microencapsulation technology means that a much smaller 21G needle can be used, and there are no blockages. Other Q-Sphera products use even finer needles as small as 27G. The importance of this is evident from the first-in-human phase I data where MTD201 had lower injection pain – 8% for MTD201 versus 25% for SLAR™, and much lower injection site tenderness – 8% for MTD201 versus 83% for SLAR.