One of the hottest stocks on the market today, resTORbio, Inc. (NASDAQ: TORC) is seeing massive gains and even larger volume. The stock is trading up by more than 60% after the company announced news surrounding a Phase 2b clinical trial in respiratory tract infections. While the data seemed positive, I urge you not to be fooled. The truth of the matter is that the drug, for the most part, doesn’t work. Until otherwise proven, don’t consider this to be an effective candidate.

Today’s News Suggests That TORC Clinical Results Were Positive

resTORbio is flying for a reason. At the end of the day, the press release announcing the results was parsed perfectly to make the clinical trial look like a smashing success. In the announcement, the company pointed to what it called “positive topline results” from a dose-ranging Phase 2b clinical trial.

The trial, which enrolled 652 elderly patients at an increased risk of morbidity and mortality associated with respiratory tract infections (RTIs), did hit it’s primary endpoint. During the trial, RTB101 demonstrated a statistically significant and clinically meaningful reduction in percentage of patients with one or more laboratory-confirmed RTIs during the 16-week treatment period compared to placebo. The CEO of the company, Chen Schor, even praised the results of the trial, pointing to the fact that the primary endpoint was met. Here’s what he had to say:

The primary endpoint of this Phase 2b study, the percentage of patients with laboratory-confirmed RTIs, was chosen based on feedback from the FDA, and we look forward to discussing these results at our end of Phase 2 meeting with the agency… RTIs are the fourth leading cause of hospitalization in patients 65 years and older, and the second leading cause of hospitalization in patients 85 years and older in the U.S. We are committed to helping the millions of elderly patients at high risk of morbidity and mortality due to RTIs.

The Study Results Really Weren’t All That Positive

While the study results seemed to be positive from digging into the press release, the truth of the matter is that the results showed serious inconsistencies with regard to Efficacy. Let’s compare the study protocol to the results shall we?

During the Phase 2b trial assessing RTB101, there were 652 patients enrolled. These patients were at high risk of RTI-associated morbidity and mortality. TORC said that this was defined as patients at age 85 and over or patients at age 65-84 with comorbidities.

The key however with regard to the efficacy questions is how the dosing was done. Patients were randomized into various dosing arms. The first was a 10mg dose twice daily, the second was a once daily 10mg dose, or 10 mg of RTB101 combined with 0.1mg of everolimus. So, there were three key doses here.

In the release, resTORbio said that the primary endpoint was reached with the 10mg once daily dose of RTB101. However, the combination arm proved to be ineffective. At the same time, the higher dose arm proved to be ineffective. So, what we really have here is a treatment that for some patients will work at low doses, but when higher doses would be needed, efficacy dissipates, making it ineffective overall. When higher doses lead to lack of efficacy, the problem leads to questions with regard to pharmacodynamics, and can make it difficult to achieve regulatory approval.

Be Prepared For Declines Ahead

Sure, TORC is rocketing in the market today on what is being perceived by the market to be positive clinical results. The fact of the matter is that the results simply aren’t as positive as the company is making them out to be. With two-thirds of the dosing cohorts proving to be ineffective, it’s hard to look at the one point of efficacy and say we have a hit here! As a result, I’m expecting to see declines ahead.



LEAVE A REPLY

Please enter your comment!
Please enter your name here