DXB announces positive outcome of FDA meeting
Hey! Looks like you have stumbled on the section of our website where we have archived articles from our old business model.
In 2019 the original founding team returned to run Next Investors, we changed our business model to only write about stocks we carefully research and are invested in for the long term.
The below articles were written under our previous business model. We have kept these articles online here for your reference.
Our new mission is to build a high performing ASX micro cap investment portfolio and share our research, analysis and investment strategy with our readers.
Click Here to View Latest Articles
A summary of the minutes from a pre-IND meeting held with the Food and Drug Administration (FDA) on the 29th June 2016, released by Dimerix, show that clinical-stage biotech company Dimerix (ASX:DXB) received a positive reception.
The meeting clarified the path of registration for DMX-200 to be used in the treatment of patients with chronic kidney disease (CKD), specifically for the orphan indication of Focal Segmental Glomerular Sclerosis (FSGS) in the USA, for which DXB has already secured orphan designation.
Identified using DXB’s proprietary screening assay, DMX-200 combines two existing drugs, a chemokine receptor CCR2 blocker used for its anti-inflammatory properties, and an angiotensin II type I receptor blocker which is registered in the US for treatment of high blood pressure and diabetic nephropathy, a disease of the kidney.
The meeting with the FDA validated DXB’s patented screening technology, termed Receptor-Heteromer Investigation Technology (Receptor-HIT), as important in understanding new treatments.
Appropriate endpoints for a pivotal Phase III trial in FSGS was also discussed providing DXB with vital information to assist in the design of the likely single pivotal Phase III trial required to secure registration for DMX-200. The FDA confirmed that a substantial change in proteinuria, common in FSGS patients, may be an acceptable endpoint for traditional or accelerated approval.
DXB confirmed with the FDA that angiotensin receptor blockers are standard of care in the treatment of chronic kidney diseases.
One of the components of DMX-200 will be packaged as a standalone therapy for co administration, rather than packaged in combination with other drugs, reducing the costs and complexity of the clinical trial process. This allows for a smaller pivotal trial requiring fewer patients.
The FDA provided further valuable information and advice for DXB to maximise the supporting value of the current Phase II trial to take DMX-200 through to the pivotal Phase III trial.
As an investor it is important to note that there is no guarantee that DMX-200 will pass clinical trials or receive FDA approval, so seek professional financial advice before making an investment decision.
With more than 26 million people suffering from chronic kidney disease in the United States alone, the need for better treatment options persists.
General Information Only
S3 Consortium Pty Ltd (S3, ‘we’, ‘us’, ‘our’) (CAR No. 433913) is a corporate authorised representative of LeMessurier Securities Pty Ltd (AFSL No. 296877). The information contained in this article is general information and is for informational purposes only. Any advice is general advice only. Any advice contained in this article does not constitute personal advice and S3 has not taken into consideration your personal objectives, financial situation or needs. Please seek your own independent professional advice before making any financial investment decision. Those persons acting upon information contained in this article do so entirely at their own risk.
Conflicts of Interest Notice
S3 and its associated entities may hold investments in companies featured in its articles, including through being paid in the securities of the companies we provide commentary on. We disclose the securities held in relation to a particular company that we provide commentary on. Refer to our Disclosure Policy for information on our self-imposed trading blackouts, hold conditions and de-risking (sell conditions) which seek to mitigate against any potential conflicts of interest.
Publication Notice and Disclaimer
The information contained in this article is current as at the publication date. At the time of publishing, the information contained in this article is based on sources which are available in the public domain that we consider to be reliable, and our own analysis of those sources. The views of the author may not reflect the views of the AFSL holder. Any decision by you to purchase securities in the companies featured in this article should be done so after you have sought your own independent professional advice regarding this information and made your own inquiries as to the validity of any information in this article.
Any forward-looking statements contained in this article are not guarantees or predictions of future performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results or performance of companies featured to differ materially from those expressed in the statements contained in this article. S3 cannot and does not give any assurance that the results or performance expressed or implied by any forward-looking statements contained in this article will actually occur and readers are cautioned not to put undue reliance on forward-looking statements.
This article may include references to our past investing performance. Past performance is not a reliable indicator of our future investing performance.
