Cidara Therapeutics, Inc. (NASDAQ:CDTX) Files An 8-K Regulation FD DisclosureItem 7.01 Regulation FD Disclosure.
On March19, 2018, Cidara issued a press release announcing the results of its Phase 2 clinical trial of rezafungin acetate, called the STRIVE study. The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01 Other Events.
On March19, 2018, Cidara reported topline results from the STRIVE global, randomized Phase 2 clinical trial of rezafungin.
STRIVE was an international, multicenter, double-blind clinical trial evaluating the safety, tolerability and efficacy of once-weekly dosing of rezafungin compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis. Patients were randomized to one of two rezafungin arms or to the caspofungin arm. In the two rezafungin arms of the trial, patients received either 400 mg of rezafungin administered intravenously once weekly for two to four weeks (Group 1), or 400 mg for the first week followed by 200 mg once weekly for up to four weeks in total (Group 2). In the comparator arm (Group 3), patients received daily caspofungin administered intravenously according to the approved prescribing information, with an optional step down to oral fluconazole. The STRIVE trial results include efficacy data from 92 treated patients (the mycological intent-to-treat, or mITT, population) and safety and tolerability results from 104 patients, from 31 trial sites in North America and Europe. The trial was not statistically powered to demonstrate superiority or non-inferiority and therefore comparisons of efficacy are directional.
STRIVE met its primary objectives related to tolerability and safety of rezafungin in the treatment of candidemia/invasive candidiasis. Topline efficacy data are summarized in Table 1. Overall success is defined as eradication of Candida from the blood or infected organ, plus clinical cure, which is defined as resolution of clinical signs of infection which were present at baseline. Additionally, clinical response is assessed by the principal investigator based on the clinical and microbiological resolution of disease.
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Table 1: Overall Response and Principal Investigator (PI) Assessment of Clinical Response at Day 14 and All-Cause Mortality in the mITT Population |
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Group 1: Rezafungin once weekly 400 mg N= 33 |
Group 2: Rezafungin once weekly 400mg Week 1/200mg N= 31 |
Group 3: Caspofungin once daily 70 mg Day 1/50 mg N= 28 |
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n (%) |
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Overall Success (Day 14) |
19 (57.6) |
22 (71.0) |
18 (64.3) |
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Failure |
7 (21.2) |
6 (19.4) |
8 (28.6) |
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Indeterminate |
7 (21.2) |
3 (9.7) |
2 (7.1) |
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Overall Success (Day 14) (excluding Indeterminatesa) |
19/26 (73.1) |
22/28 (78.6) |
18/26 (69.2) |
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Failure |
7/26 (26.9) |
6/28 (21.4) |
8/26 (30.8) |
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Clinical Cure (Day 14) by PI Assessmentb |
25 (75.8) |
24 (77.4) |
20 (71.4) |
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Failure |
7 (21.2) |
4 (12.9) |
8 (28.6) |
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Indeterminate |
1 (3.0) |
3 (9.7) |
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Mortality (Day 30)c |
5 (15.2) |
1 (3.2) |
3 (10.7) |
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Mortality (Overall) |
5 (15.2) |
3 (9.7) |
5 (17.9) |
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aIndeterminate response indicates inability to assess outcome due to missing data point(s) bOutcome that most closely approximates the primary outcome in prior candidemia/invasive candidiasis clinical trials cPrimary outcome measure for planned Phase 3 ReSTORE trial to assess rezafungin in treatment of candidemia and/or invasive candidiasis |
Rezafungin was generally well-tolerated at both dosing regimens. Treatment emergent adverse events were observed in most patients, with an incidence of 88.6 percent in Group 1, 94.4 percent in Group 2, and 81.8 percent in Group 3.
The rates of severe adverse events were 37.1 percent, 27.8 percent, and 39.4 percent, respectively. There were six adverse events leading to study drug discontinuation across all study groups: four in Group 1, one in Group 2 and one in Group 3. Two of six were considered possibly related to study drug, one in Group 1 and one in Group 3.
There were two serious adverse events possibly related to study drug: one in Group 2 and one in Group 3, and both patients fully recovered. There were no deaths related to study drug, and there were no concerning trends in System Organ Class groups or specific adverse events.
Based on the STRIVE trial results, Cidara plans to initiate two Phase 3 clinical trials of rezafungin in mid-2018:
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Phase 3 ReSTORE Treatment Trial: A single, global, randomized, double-blind, controlled Phase 3 pivotal clinical trial in approximately 150 mITT patients with candidemia and/or invasive candidiasis. This global Phase 3 trial is expected to generate topline data in 2020. The design will be similar to the STRIVE study, but with a 2:1 randomization regimen and a primary outcome measure of all-cause mortality at day 30. |
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Phase 3 ReSPECT Prophylaxis (Prevention) Trial: A single, global, randomized, double-blind, controlled Phase 3 pivotal clinical trial in patients undergoing allogeneic bone marrow transplant to assess rezafungin in a 90-day prophylaxis regimen to prevent infections due to Candida, Aspergillus and Pneumocystis. Rezafungin will be dosed once weekly and compared to a regimen containing two drugs (an azole and Bactrim) dosed once daily, for 90 days, at which time fungal-free survival (the primary outcome measure) will be measured. The trial will include adults with underlying conditions including acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome(s), lymphoma and aplastic anemia. This trial is expected to produce an interim analysis with adaptive design and futility read-out in 2019 and provide topline results in 2020. |
Statements contained in this report regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effectiveness, safety, and other attributes of rezafungin, including the potential for these compounds to successfully treat or prevent infections, including those caused by resistant pathogens, the potential for rezafungin to have advantages over the current standard of care in the treatment or prevention of invasive fungal infections, and the design and timing of rezafungin Phase 3 clinical trials. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara’s plans to develop and commercialize its product candidates; Cidara’s ability to obtain additional financing; Cidara’s ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara’s Form 10-K most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this report speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Item 7.01 Financial Statements and Exhibits.
(d) Exhibits
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ExhibitNo. |
Description |
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99.1 |
Press release issued March 19, 2018.
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Cidara Therapeutics, Inc. ExhibitEX-99.1 2 ex9912018-03×19.htm STRIVE TOPLINE DATA RELEASE Exhibit Exhibit 99.1FOR IMMEDIATE RELEASECidara Therapeutics Reports Positive Topline Results from Phase 2 STRIVE Trial of Lead Antifungal RezafunginFavorable safety,…To view the full exhibit click here
About Cidara Therapeutics, Inc. (NASDAQ:CDTX)
Cidara Therapeutics, Inc., formerly K2 Therapeutics, Inc., is a clinical-stage biotechnology company. The Company is engaged in the discovery, development and commercialization of anti-infectives. It is developing a pipeline of product and development candidates with a focus on serious fungal infections. Its product portfolio consists of over two formulations of its echinocandin, CD101. CD101 IV is a long-acting therapy for the treatment and prevention of serious, invasive fungal infections. CD101 topical, its second product candidate, is being developed for the treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), a prevalent mucosal infection. Its immunotherapy technology platform, Cloudbreak, is used to create compounds designed to direct a patient’s immune cells to attack and eliminate pathogens that cause infectious disease.
