Pivotal Registration Clinical Study with XRx-008 and Phase 2b Clinical Study withTMX-049 Planned in 2020
XORTX Therapeutics Inc. (“XORTX” or the “Company”) (CSE: XRX; OTCQB: XRTXF), a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, confirms that the Company has filed its audited financial statements and related management’s discussion and analysis for the year ended December 31, 2018. The Company’s MD&A highlights the significant milestones accomplished by XORTX in its first year as a listed public company. Both of XORTX’s advanced clinical programs are focused on treating progressive kidney disease through the lowering of serum uric acid as highlighted below in this press release.
Dr. Allen Davidoff, Founder and CEO of XORTX stated:
“We are encouraged by the advancements made by XORTX in 2018 and thus far in 2019 and in particular, the validation of our efforts to develop uric acid lowering agents to slow or reverse progressive kidney disease has been multi-faceted, with acknowledgment by the PKD Foundation, and most notably by two recent published studies by the TODAY study team and Dr. Petter Bjornstad (see press release of April 16, 2019) and the Pilemann-Lyberg et al study published in the American Diabetes Association Journal (see press release of March 25, 2019). Both of these studies reveal that serum uric acid levels significantly affect the progression of kidney disease in adolescents with T2 diabetes and patients with T1 diabetes, respectively. Our recently announced agreement with Teijin further expands the Company’s product offerings beyond XRx-008 to include TMX-049 for type 2 diabetic nephropathy (“T2DN”), a large and rapidly growing unaddressed medical need.”
“We are highly optimistic about the future of our XRx-008 program which is poised to advance to a pivotal phase 3 clinical trial in 10 months and our secondary program in T2DN planned to enter phase 2b proof of concept testing in 14 months. XORTX plans to undertake a non-brokered financing of up to $5 million of units priced at $0.20, with each unit comprising one common share and one-half common share purchase warrant exercisable at $0.40 for a one year term to fund the advancement of these two important clinical trials.”
The Company anticipates that the private placement will be completed by May 31, 2019 and notes that the private placement is subject to regulatory approval and all securities issued will be subject to a statutory hold period of four months.
The following summarizes the advancements made in 2018 to date in XORTX’s two programs:
XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD):
- Formal recognition by the Polycystic Kidney Disease (PKD) Foundation of America (the “PKD Foundation”) as a leader advancing the development of treatments for PKD and specifically rare diseases such as ADPKD and an ongoing cooperative working relationship.
- Preparation and filing Pre-IND documents with the FDA related to the development of XRx-008 – an oxypurinol formulation – for the treatment of autosomal dominant polycystic kidney disease (“ADPKD”).
- Filing of Orphan Drug Designation (“ODD”) documents with the FDA for XRx-008 for the treatment of ADPKD and FDA clarification of additional information required to obtain ODD status for XRx-008.
- Meeting and discussion with the FDA regarding XRx-008 Clinical Development Plan resulting in an accelerated clinical development plan composed of a bioavailability study of XRx-008 in man, then a single phase 3 registration clinical trial (under a special protocol assessment (SPA)).
- Thereafter submission of a New Drug Application (NDA) for marketing approval.
XRx-221 (TMX-049) for Type 2 Diabetic Nephropathy (T2DN):
- Negotiated and signed a Letter of Intent for the co-development of TMX-049 with Teijin Pharma Limited (“Teijin”). This agreement would provide XORTX with exclusive global rights (excluding Japan) to develop TMX-049, a new generation of xanthine oxidoreductase inhibitor, for the treatment of T2DN. Teijin has already devoted considerable time, funding and resources to the development of TMX-049 in T2DN. At present, a Phase 2a study in T2DN patients in the US, has completed enrollment and anticipated to report topline results in Q3 2019.
- After execution of the definitive agreement contemplated by the LOI, XORTX and Teijin will work together on the development of the phase 2b clinical program for the treatment of T2DN. For further information, refer to the Company’s press release of March 12, 2019.
About XORTX Therapeutics Inc.
XORTX Therapeutics Inc. is a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease. XORTX has lead programs to develop treatments for progressive kidney disease due to diabetes, diabetic nephropathy and polycystic kidney disease. Secondary programs focus on developing therapies for health consequences that accompany pre-diabetes, diabetes and cardiovascular disease. Additional information on XORTX Therapeutics is available at www.xortx.com.
| For further information, please contact: | ||
| Allen Davidoff, CEO | Erik Matthews, Corporate Communications | |
| adavidoff@xortx.com or +1 403 455 7727 | erik@xortx.com or +1 747 203 5240 | |
Email
Text