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• Path to the near term milestone of filing IND for the first US study (PK study) – no apparent roadblocks or extra costs identified at this stage
• DMX-200 to be treated as an adjunct therapy rather than a combination therapy – resulting in a much smaller pivotal trial which is less expensive as it requires fewer patients
• Potential for approval from a single pivotal Phase III trial with single end point of improvement in proteinuria from baseline – bringing huge cost benefits over running two Phase III trials
• Recognition of the importance of heterodimer pharmacology – validating the patented Dimerix technology in identifying new treatments
MELBOURNE, Australia, 1st August 2016: Dimerix Limited (ASX: DXB), a clinical-stage biotechnology company committed to discovering and developing new therapeutic treatments identified using its proprietary screening assay, today announced it has received the minutes from the pre-IND meeting held with the US Federal Drug Administration (FDA) on the 29th June 2016. The minutes confirm the positive reception for this new therapeutic and provide a range of important clarifications for the path to registration DMX-200 as a treatment for patients with chronic kidney disease (CKD), specifically, for the orphan indication of Focal Segmental Glomerular Sclerosis (FSGS) in the USA.
DMX-200 was identified using Dimerix’s proprietary screening assay, termed Receptor-Heteromer Investigation Technology (Receptor-HIT), and it combines two existing drugs, a chemokine receptor CCR2 blocker (propagermanium) used for its anti-inflammatory properties, and an angiotensin II type I receptor blocker (irbesartan) which is registered in the USA for hypertension and treatment of diabetic nephropathy. Dimerix has already secured orphan designation for DMX-200 for FSGS.
During the pre IND meeting Dimerix confirmed with the FDA that as angiotensin receptor blockers (ARB’s), including irbesartan, are standard of care for treatment of chronic kidney diseases, it is appropriate that DMX-200 is positioned as an adjunct therapy and not a fixed dose combination therapy. Dimerix thus plans to package Propagermanium as an extended release formulation, reducing dosage from current three times daily dosing, to be delivered to patients on irbesartan therapy.
The treatment of DMX-200 as an adjunct therapy greatly reduces the complexity of the Phase III trial required for registration, compared with those for a fixed dose combination therapy. Moreover, it provides a relatively simple, and inexpensive, path to opening an IND for a pharmacokinetic (PK) study for the extended release formulation. There were no major roadblocks identified for the near term milestone of opening the IND.
A substantial portion of the meeting was focused on identification of appropriate end points for a pivotal Phase III trial in FSGS. Proteinuria is common in FSGS patients and is broadly accepted as a strong independent risk factor for disease progression. In the minutes from the pre-IND meeting the FDA advised that for DMX-200 “A substantial change in proteinuria in patients with marked proteinuria at baseline may be an acceptable endpoint for traditional or accelerated approval…”. Extensive discussion of this point provided Dimerix with vital information to assist in the design of the likely single pivitol Phase III trial required to secure registraion for DMX-200.
The FDA also provided valuable feedback on the ongoing Phase II trial currently underway in Australia that assists Dimerix to maximise the supporting value of this Australian trial to the pivotal Phase III trial.
Dimerix Executive Chairman Dr James Williams said, “The FDA was extremely helpful in providing Dimerix with advice and information to help us succeed in the development of DMX-200 for FSGS. As this rare and severe disease has no current effective treatments, the FDA has shown significant interest in assisting companies to expedite their development path to ensure treatment options are made available to patients as quickly as possible. By opening this dialogue early with the Agency, Dimerix has received guidance as to the type of information that will ultimately be required, de-risking the program significantly and as a consequence, it appears substantial further investment should not be required before filing the IND for the PK study (initial study under US IND). We were also particularly pleased with the recognition of the importance of heterodimer pharmacology in the development of new therapeutic approaches as this encourages us to further leverage our platform into new drug discovery programs.”
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