Data Readout

BioVersys plans BV100 interim readout as its Phase 3 program runs in parallel

The open-label RIV-CARE Phase 2b trial in drug-resistant Acinetobacter infections has not yet started enrolling, testing the timeline for a Q4 2026 safety and efficacy interim look.

By AppliedXLJuly 13, 2026Trial NCT07431307

Executive Summary

BioVersys has told investors to expect an interim look at a Phase 2b safety and efficacy trial for BV100 before the end of 2026, even though that trial has not yet opened for enrollment.
The interim analysis is built around a safety endpoint, not an efficacy comparison, so its primary value is confirming tolerability of BV100 combination regimens rather than proving a clinical benefit.
BV100's efficacy case already rests on a separately running Phase 3 trial, which puts the near-term interim analysis in a supporting role rather than the deciding one for the program.
No direct comparator sharing BV100's mechanism is active in this indication, leaving the asset to be judged against the disease's severity and the sponsor's own prior data rather than a competing therapy.

The catalyst

BioVersys AG said on April 16, 2026 that it plans a first interim readout from its open-label Phase 2b RIV-CARE trial of BV100 toward the end of 2026, alongside the launch of its pivotal Phase 3 RIV-TARGET trial. RIV-CARE is registered as NCT07431307, testing BV100 combined with low-dose polymyxin B, ceftazidime/avibactam, or cefiderocol in patients with pulmonary and extrapulmonary infections caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The trial targets 120 patients and carries a Not yet recruiting status, with a start date of July 1, 2026 and a primary completion date of March 1, 2028. BioVersys+1

Probability of Success

Endpoint Met49%

Completes93%

Clinical Significance9%

Regulatory26%

What the endpoint measures

The registered primary endpoint is the incidence of treatment-related treatment-emergent adverse events in the safety population, measured through the end-of-study visit across the trial's Part A and Part B. Secondary endpoints include 14-day and 28-day all-cause mortality and clinical cure at test-of-cure in Part A, and rifabutin cerebrospinal-fluid concentrations at steady state in Part B. That design means the interim analysis is built to answer a tolerability question first: whether combining BV100 with polymyxin B, ceftazidime/avibactam, or cefiderocol adds toxicity beyond what each combination partner carries on its own. Any mortality or clinical-cure signal from Part A would be exploratory rather than the trial's decision-grade output. NCT07431307

The parallel Phase 3

BioVersys separately dosed its first patient in the global pivotal Phase 3 RIV-TARGET trial (NCT07326540) in April 2026, which compares BV100 plus low-dose polymyxin B against colistin plus high-dose ampicillin-sulbactam in roughly 300 patients with suspected or confirmed HABP or VABP due to CRABC. BioVersys said that trial follows a Phase 2 study showing a 50% reduction in mortality compared with best available therapy. Chief Executive Officer Marc Gitzinger said the RIV-CARE trial is meant "to collect further safety experience and evidence of clinical efficacy in a first interim read-out towards the end of 2026," positioning it as a supporting dataset to the Phase 3 program rather than its replacement. BioVersys

Timing and operations

The trial's Not yet recruiting status, set against a stated Q4 2026 interim-analysis window, means the interim readout depends on enrollment beginning and progressing inside roughly two quarters. The enrollment target has not changed since the trial was first posted, holding at 120 patients, which the operational model treats as within the routine band for this design. Protocol stability is rated stable, with no amendments recorded to the primary endpoint, eligibility criteria, or completion date since the trial's registration on February 24, 2026. NCT07431307

Competitive and regulatory context

No competitor sharing BV100's mechanism, an intravenous rifabutin formulation built on an active-uptake pathway into CRABC, is active in this indication, and the trial carries no direct comparator in the competitive landscape data. BV100 holds Qualified Infectious Disease Product designation from the FDA, which BioVersys said makes it eligible for priority review, Fast Track designation, and a five-year extension of market exclusivity in the US. CRABC infections carry mortality rates BioVersys has described as reaching 50% in hospital settings with limited treatment options, a severity context against which any interim safety or clinical-cure data will be read. BioVersys

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