MTD201 is being developed as a treatment for a hormonal disorder called acromegaly, as well as for carcinoid cancer.
Novartis has already cornered a large slice of the market with its Sandostatin LAR drug, but the interim data has shown MTD201 to be, at worst, a good alternative or, at best, a “differentiated improved product”.
Like SLAR, MTD201 was safe and effective, but among the key advantages is that it requires a smaller needle which blocks less frequently.
The reconstitution process – adding a diluent to the drug – was found to be simpler with MTD201, leading to fewer reconstitution errors and less wastage.
Perhaps most importantly though, the results provide a successful clinical 'proof of concept' for Midatech's Q-Sphera sustained release technology, which it is using in some of the other drugs it is testing.
Ahead of a follow-on trial, the company will speak to regulators to get their opinion on whether to pursue MTD201 as an equivalent to, or improved version of Novartis’ SLAR.
“After five years of development, we are delighted to have achieved positive first-in-human data,” said chief executive Craig Cook.
“First, for the MTD201 programme, whilst one objective of the study was to determine whether MTD201 was bioequivalent to Sandostatin LAR with a potentially shorter route to market, this data suggests that we have a better product with an improved clinical profile.
“Combined with the other advantages around smaller needle size, simpler and more reliable reconstitution and injection, this could lead to a more valuable product either to develop internally or license to pharmaceutical partners.
Cook added: “Second, this study is a major validation and inflection point for Midatech's Q-Sphera technology establishing it as an exciting new sustained-release delivery platform, to administer pharmaceuticals safely, conveniently and effectively, without a burst phenomenon, and over a prolonged period.”
Sustained release system
Midatech’s Q-Sphera technology works to deliver a drug to the right place at the right time.
It is a sustained release platform and the company has adopted 3D and inkjet printing techniques to create particles that dissolve in a certain way over a certain time-scale.
Q-Sphera allows drug compounds to be released into the body in a “highly controlled manner” over a prolonged period of time; potentially from a few days to up to six months.
Big companies are starting to take note of the delivery platform, too, with an unnamed "leading global pharma corporation" recently agreeing a deal to trial the technology.
More than just MTD201…
Away from MTD201, Midatech’s other key clinical programme is called MTX110 - a potential treatment for a rare type of brain tumour found in children, continues to “progress well”.
According to an update over summer, the programme continues to “progress well”.
In that same release, Midatech added that preparation work to take its MTD119 liver cancer drug into the clinic is currently underway.
Back in June, the firm enrolled its first patient in a clinical study of Gelclair which could expand the market for the cancer treatment.
Gelclair is already prescribed for an after effect of radiation and chemotherapies called oral mucositis, painful and debilitating inflammation and ulceration of the surface of the mouth.
The US phase IV study will assess the product's use in patients undergoing stem cell transplant therapy.
The main objective is to confirm the efficacy and tolerability of Gelclair for the treatment of oral mucositis in people receiving allogeneic stem cell transplants alongside high-dose chemotherapy.
Alongside its other drugs, Midatech is also delivering another delivery platform in addition to Q-Sphera.
Like Q-Sphera, the firm’s carbohydrate-coated gold nano-particles are about getting medicines to the right place in the right quantities at the right time, although they go about that in slightly different ways.
The gold nanoparticles, or GNPs for short, promise a revolution in targeted therapies for cancer. To radically simplify, the process deploys these GNPs to act like guided missiles.
In treating cancer with traditional chemotherapy, for instance, they are programmed to hit only a specific tumour type with their payload.
This highly targeted approach allows physicians to potentially administer lower doses and it also means there is little collateral damage.
Revenue up, losses narrowed
Excluding the US division which is set to be sold off in a US$19mln deal, revenue – income from R&D collaborations plus grants – rose 17% to £0.55mln in the six months ended June 30 (H1 17: £0.47mln).
Loss from operations fell 7% to £5.62mln H1 17: £6.04mln), while net cash outflow totalled £8.39mln (H1 17: £11.42mln).
“The first half of 2018 has been a period of significant change and good progress for the reshaped Midatech business,” said CEO Cook.
“We report a period of excellent R&D progress with all our lead product candidates now in the clinic and, post the period end, an exciting positive data readout from our MTD201 study.
“We are committed to continuing and building on this momentum as a streamlined R&D player, with a particular focus on advancing MTD201 and MTX110 to market as quickly as possible.”
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