Biotech Values

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ITRM> Sulopenum looks approvable unless I'm missing something. The Phase 3 failed against Cipro in the quinolone susceptible population but was superior to Cipro in the quinolone resistant population. These were prespecified populations.

Disclosure: I took a flier on ITRM about a month ago and also have it in the SI biotech contest. The FDA accepted ITRM's NDA application today with an Adcom scheduled for July 25.

From ITRM's 10Q...
https://www.sec.gov/Archives/edgar/data/1659323/000156459020054013/itrm-10q_20200930.htm

In the second quarter of 2020, we announced the results of our Phase 3 clinical trials in cUTI and uUTI. In the cUTI trial, sulopenem did not meet the primary endpoint of statistical non-inferiority compared to the control therapies with the difference in response rates driven almost entirely by higher rates of asymptomatic bacteriuria on the sulopenem IV to oral sulopenem arm relative to the ertapenem IV to oral ciprofloxacin arm, only evident at the test of cure visit. The rates of patients receiving additional antibiotics or with residual cUTI symptoms were similar between therapies. Similarly, in the uUTI trial, sulopenem did not meet the primary endpoint of statistical non-inferiority compared to ciprofloxacin in the population of patients with baseline pathogens susceptible to ciprofloxacin driven to a large degree by a greater amount of asymptomatic bacteriuria in the sulopenem treated patients at the test of cure visit relative to those receiving ciprofloxacin. However, in the uUTI trial, in the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing evidence of a treatment effect in patients with uUTI.Based on discussions with the FDA at a pre-New Drug Application, or NDA, meeting in September 2020 and previous correspondence with the FDA, we plan to proceed with an NDA submission for oral sulopenem for the treatment of uUTIs in patients with a quinolone non-susceptible pathogen in the fourth quarter of 2020.

Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem for the Treatment of Uncomplicated Urinary Tract Infections

https://www.globenewswire.com/news-release/2020/06/29/2054608/0/en/Iterum-Therapeutics-Announces-Topline-Results-from-its-Phase-3-Clinical-Trial-of-Oral-Sulopenem-for-the-Treatment-of-Uncomplicated-Urinary-Tract-Infections.html

Quinolone Non-susceptible Population
Overall Response (TOC)
Sulopenem 92/147 (62.6%)
Cipro 50/139 (36.0%)
Difference 26.6% (15.1, 37.4)
P value< 0.001

Reason for Failure: Asymptomatic bacteriuria
Sulopenum 27 (18.4%)
Cipro 38 (27.3%)

Clinical Response (TOC)
Sulopenum 122/147 (83.0%)
Cipro 87/139 (62.6%)
Difference 20.4% (10.2, 30.4)
P Value < 0.001

Overall Response (EOT)
Sulopenum 95/147 (64.6%)
Cipro 42/139 (30.2%)
Differnece 34.4% (23.1, 44.8)
P Value < 0.001

“The difference in the overall response to treatment in the population of patients with a quinolone susceptible baseline pathogen was driven to a large degree by a greater amount of asymptomatic bacteriuria in the sulopenem treated patients relative to those receiving ciprofloxacin,” observed Dr. Dunne. “This same finding was observed in the recently completed Phase 3 clinical trial of sulopenem in complicated urinary tract infections, SURE2. In that study, the difference in outcome between ertapenem and sulopenem was driven largely by the post therapy rate of asymptomatic bacteriuria and, notably, was lower only in those patients who received ertapenem followed by ciprofloxacin and not in any other pairwise comparison with sulopenem or ertapenem treated patients. The clinical significance of post treatment asymptomatic bacteriuria and its relationship to oral dosing with ciprofloxacin will be the focus of additional investigation.”

In the safety population of 1,660 patients, treatment related adverse events were observed in 11.4% and 11.9% of patients on sulopenem and ciprofloxacin, respectively. The most commonly reported adverse events were diarrhea, 7.3% and 7.6%, nausea, 3.4% and 4.0%, and headache 2.2% and 2.2%, for sulopenem and ciprofloxacin patients, respectively. Discontinuations due to adverse events were uncommon on both regimens and were seen in 1.1% of patients on sulopenem and 1.5% of patients on ciprofloxacin. Serious adverse events (SAE) were seen in 0.6% of patients on sulopenem with no drug-related SAE and 0.4% of patients on ciprofloxacin with one drug-related SAE.