Australian biomedical company Factor Therapeutics (ASX: FTT) will cease development of its VF001 drug for the treatment of chronic venous leg ulcers after a Phase 2 trial failed to prove the drug will improve healing in patients.
The “disappointing results” released by the company this morning showed that use of the drug across a group of 157 trial patients demonstrated “no clinically-meaningful or statistically-significant” difference in the measure of wound size, wound healing or duration of healing period, compared to a placebo drug.
The placebo-controlled trial aimed to evaluate the addition of VF001 to standard care dressings and compression bandaging for patients with chronic venous leg ulcers over a 12-week period.
A secondary objective was to generate sufficient data to trigger meaningful commercial and partnering opportunities.
Patients were recruited at 21 sites across the United States for the 18-month trial and randomised to receive standard care plus one of two VF001 doses – low (28 micrograms per millilitre) or high (280mg/ml) – or a placebo.
Across all three measures of healing – reduction in wound size, full healing, and the time taken to achieve full healing – treatment with VF001 showed no additional benefits when compared with placebo-plus-standard care.
Expectation vs reality
In October, Factor Therapeutics announced it was expecting “top line results” following the completion of VF001’s lengthy trial.
This morning, chief executive officer Dr Rosalind Wilson said the reality of the results signal the end of the road for the drug’s development.
“We undertook this trial with the goal of determining whether [this drug] improves healing for patients and unfortunately, the results clearly demonstrate that it does not,” she said.
“While the trial was well designed and executed, there is no clinical justification to progress further with the development of this asset.”
The failed trial has spurred a change in Factor’s corporate structure, with the announcement that Dr Wilson will stand down from her role in the near future.
The board of directors have agreed to remain in place without remuneration.
Chairman Cherrell Hirst told Small Caps the company’s priority is to halt all activities relating to VF001 in all indications.
“Although we did plan for this eventuality, it wasn’t what we were expecting and we see no justification in continuing to develop VF001 [or its ocular variations] any further,” she said.
“The most important move at this point is to halt all work relating to VF001… there is a lot involved in notifying the various vendors and suppliers that they should cease activity.
“As part of that process, we will downsize the company and over the coming months, we will evaluate our options going forward.”
Factor Therapeutics’ stock was hit hard on announcement of the trial results.
By mid-afternoon trade, the company’s share price had dropped 97.26% to $0.002.