The announcement of 14 January 2020 appeared to throw a spanner into the works. Some investors read the news and took the sell first and ask questions later approach. Its an unsurprising reaction because any question mark is always treated with deep suspicion.
The offending question mark relates to the second half pre-clinical study in 2019 that was unable to generate results in any arm of the study including the control and competing product arms. At first glance the only thing that sticks out is the fact that there was no difference between the control arm (no treatment) and AD-214. No wonder alarm bells rang. In a clinical trial setting, no difference between placebo and the investigational new drug would spell futility.
The announcement, however, stated that no results could be generated between control and competing product arms. Yes, that included AD-214 but also included for comparative purposes, either pirfenidone, nintedanib or AMD-3100. In other words there was also no difference between the control and for instance, pirfenidone. Note: the announcement does not specifically spell out the drugs used in the competing drug arms.
Now something is just plain wrong with the way the pre-clinical trial was run. I have done some research in relation to pirfenidone in order to understand what could have been expected between no treatment and treatment with pirfenidone. Firstly, the biggest clue is that pirfenidone is approved for IPF. The drug sponsored by Genentech Roche was approved by the FDA in October 2014 based upon a phase 3 clinical trial comparing the treatment to placebo. That's probably all we need to know but of interest is a study published in the journal Respiratory Medicine in August 2019 titled Pirfenidone in real life: A retrospective observational multicentre study in Italian patients with idiopathic pulmonary fibrosis. The study concluded that pirfenidone shows similar benefits for people with IPF in real world settings as it does in clinical trials.
In other words, the pre-clinical trial didn't throw up a result in relation to the efficacy of AD-214. It simply couldn't generate any results.
1AD Price at posting:
10.0¢ Sentiment: Buy Disclosure: Held
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