resTORbio Releases Additional Trial Data

Months after releasing initial positive topline data for its Phase 2b trial of RTB101, resTORbio (NASDAQ:TORC) released additional data on Tuesday (October 16) for the trial.

resTORbio is developing drugs to target the TORC1 pathway which regulates aging that may also target extending healthy lifespans. RTB101 is the company’s only drug in development.

The data released in July focused on respiratory tract infection (RTIs) indications. Tuesday’s announcement sheds light on RTB101’s implications on urinary tract infections (UTIs).

The first data released detailed how the company met primary endpoints, whereas this second set of data showcases how secondary endpoints and exploratory were met.

“RTB101 10 mg once daily was observed to decrease not only the incidence of RTIs, but also the severity of RTI symptoms,” Joan Mannick, chief medical officer of resTORbio, said in the press release. “We continue to develop our clinical strategy for UTIs, including dose selection.

The company confirmed in its July release that the 10 mg dose had been identified for RTI patients, but the dose for UTI patients “remains to be determined.”

Patients were dosed daily for either the placebo or resTORbio’s drug, and all results are laboratory-confirmed.

The 10 mg dose for RTIs had over a 50 percent reduction in severe symptoms at 16 weeks, and over forty percent for the same endpoint for the 5 mg dose of the drug. The occurance of RTIs decreased over 27 percent for patients on the 10 mg dose during the 24 week period and close to 20 percent for the patients on the 5 mg dose.

Over 23 percent of patients had a reduction in overall infections for the 10 mg daily dose, whereas over 15 percent of patients had a reduction in the same infections which dosed 10 mg twice daily.

The amount of UTIs were reduced by close to 35 percent of patients, which dosed 10 mg once daily, and almost 75 percent of patients which dosed the same amount twice daily.

The trial design was to find a preferred dose for the primary RTI indication; it was double-blind and placebo-controlled at multiple study sites. Total enrollment was close to 700 patients who were 85 years of age or older or 65 years and older who had asthma, type 2 diabetes, chronic obstructive pulmonary disease or were chronic smokers.

The study was ongoing for 16 weeks and patients were monitored for an additional eight weeks off the drug. It was conducted within the winter cold and flu season period for patients in their respective regions.

With this information, the company plans to initiate its Phase 3 program in the first half of 2019 to reduce RTIs. It also plans to submit detailed results from this trial to an upcoming medical meeting.

RTIs are more difficult for the aging population as patients find it difficult to detect and fight off infections. It’s the fourth largest cause of hospitalizations and seventh leading cause of death for patients 65 and older in the US. RTIs also worsens asthma in these patients with most caused by viruses which have no current approved therapies.

Representing the top bacterial infection specifically in women, UTIs are responsible for US$2.8 billion in healthcare costs. Close to 30 percent of women over 85 have reported having a UTI every year. The drug currently prescribed for UTIs is one also contributing to multidrug resistant bacteria.

Investor takeaway

Over the trading period Tuesday, resTORbio’s share price increased nearly 11 percent to US$12.46.

This additional positive data from the trial may give investors more confidence in the company. As Wedbush Securities analyst Robert Driscoll previously said in a phone interview with the Investing News Network (INN), the company needs to figure out the next steps for the drug.

As mentioned, investors can look forward to the company initiating its Phase 3 trial for RTIs in the first half of 2019, other news can be found on the company’s site.

Don’t forget to follow@INN_LifeScience for real-time updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.