- ASX listed clinical-stage healthcare company Dimerix Limited announced positive results in Phase 2 clinical trial of DMX-200 in diabetic kidney disease patients.
- Following the announcement, Dimerix Limited’s share price fell sharply and ended ~63% lower at A$0.275.
- Dimerix’s comment that a statistically significant variation in reduction of albuminuria for the primary endpoint was not observed led to the considerable drop in the share price.
- The Company stated that analysis of the Phase 2 trial did not show any conclusive advantage of DMX-200 compared to placebo in the complete cohort of patients with diabetic kidney disease.
On 14 September 2020, the share price of Dimerix Limited (ASX:DXB) plummeted by 62.838% to A$0.275 despite the announcement of the positive results for its Phase 2 study of DMX 200 in the diabetic kidney disease. The market capitalisation of DXB stood at A$146.33 million with almost 197.75 million shares trading on the ASX.
Let us know a bit about Dimerix and delve deep into its announcement concerning study results-
About Dimerix Limited
Clinical-stage drug development company Dimerix Limited is engaged in developing innovative therapies for unmet medical requirements in markets across the globe. Currently, the Company is developing its proprietary drug DMX-200 for diabetic kidney disease (DKD), focal segmental glomerulosclerosis (FSGS) as well as for COVID-19-associated ARDS (acute respiratory distress syndrome).
Moreover, DMX-200 was granted an Orphan Drug Designation (ODD) for FSGS by the EMA and the Food and Drug Administration. Dimerix is also developing DMX-700 for COPD (chronic obstructive pulmonary disease).
Dimerix share price dropped despite the positive top-line results from DMX-200 Phase 2 Trial
On 14 September 2020, Dimerix Limited announced positive results from a Phase 2 clinical trial in individuals with diabetic kidney disease. The Company mentioned that the findings support further development of DMX-200.
The Phase 2 clinical trial was a randomised, double-blind, placebo-controlled, crossover trial that is designed to evaluate the safety & efficacy of DMX-200 in patients with diabetic kidney disease receiving a stable dosage of irbesartan (standard of care).
In Phase 2 trial of DMX-200 total of 45 patients were enrolled, with 40 patients meeting all pre-defined criteria required for inclusion in the final assessment per the protocol. During the trial, DMX-200 240 mg was administered orally to patients with DKD who are already taking a stable 300 mg dose of irbesartan (angiotensin receptor blocker).
Consequently, the reduction in albuminuria observed from DMX-200 is in addition to any reduction in albuminuria anticipated from background therapy that would have occurred before starting on DMX-200.
Dimerix stated that DMX-200 was found to be safe and well-tolerated in patients having diabetic kidney disease.
Moreover, the Company said that in the meantime, several patients in FSGS and diabetic kidney disease trial, along with the previous Phase 2 trial in 2017, continue on treatment with DMX-200 through the Therapeutic Goods Administration’s Special Access Scheme (SAS) after completion of the respective study.
Why share price of Dimerix dropped by ~63%?
Despite the positive results, the announcement didn’t go down well with the market participants and was reflected in the share price tumble today.
Dimerix stated that during the study, there was no considerable difference between treatment with DMX-200 and placebo throughout the patient cohort.
there was only a 2% variation from baseline in 24-hour albuminuria after the twelve-week therapy with DMX-200 versus placebo.
The Company stated that a statistically significant difference in the reduction of albuminuria for the primary endpoint was not observed. However, there was a clinically substantial variation in treatment response for patients having elevated levels of albuminuria at study baseline.
The overall analysis demonstrating no conclusive benefit of DMX-200 compared to placebo across the entire cohort of DKD patients (2% difference).
Dr Hiddo Heerspink, Chair of the Dimerix Medical Advisory Board, commented-
However, with the diabetic kidney disease & FSGS renal programs, the Company continues to work on a study in patients with COVID-19-associated ARDS (Acute Respiratory Distress Syndrome), and DMX-700 in COPD.
DMX-200 for COVID-19 Patients
DMX-200 was nominated for inclusion in the REMAP-CAP study for COVID-19 patients with acute respiratory distress syndrome. The therapy is targeted for decreasing inflammatory immune cells damage by obstructing their signalling and restricting following movements.
Earlier on 3 September 2020, Dimerix was awarded AU$1 million funding from the MRFF Biomedical Translation Bridge program to support inclusion in global REMAP-CAP study for ARDS associated with COVID-19.
The Way Ahead
Despite relatively insignificant findings from the Phase 2 trial of DMX-200, Dimerix stated that it would investigate the results further to support the next stage of development of DMX 200 in kidney disease studies. Also, the Company will continue planning a Phase 3 trial in FSGS, an indication that does not currently have an approved pharmacologic treatment.