Business Wire

Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis

Share

Cidara Therapeutics, Inc. (NASDAQ: CDTX) and Mundipharma today announced positive topline data from the pivotal ReSTORE Phase 3 clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential first-line treatment for candidemia and invasive candidiasis.

Rezafungin met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorization Application (MAA) submission of global cure at Day 14. Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly, versus caspofungin dosed once-daily, the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.

“The results of the ReSTORE trial reinforce our belief that rezafungin has the potential to have a significant impact on the care of patients battling difficult-to-treat and often deadly invasive Candida infections,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We are pleased by the overall efficacy and safety results including the data on early efficacy outcomes and ICU stay. We would like to thank all of the investigators and their site staff for their relentless hard work and dedication, as well as the patients who made it possible for us to generate these data. With the results of both the STRIVE and ReSTORE trials now in hand, which together form our registration package, we intend to file our NDA with the FDA and other regulators outside the U.S., in mid-2022.”

George Thompson, M.D., principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis, School of Medicine, added, “Those of us treating deadly fungal infections have been anticipating these data and if rezafungin is approved it could be an important new option for the care of our patients. I’m excited that the data from the ReSTORE trial support a potential place for once-weekly rezafungin in the treatment of critically ill patients both inside and outside the hospital.”

Cidara has partnered with Mundipharma who has commercial rights to rezafungin outside the U.S. and Japan.

Brian Sheehan, Ph.D., chief scientific officer at Mundipharma, commented, “We are thrilled to announce these data that support the potential use of once-weekly rezafungin which, if approved, will be the first new treatment option for patients with candidemia and/or invasive candidiasis in over a decade.”

ReSTORE (NCT03667690) is a global, randomized, double-blind, controlled Phase 3 study. It completed enrollment with 187 patients diagnosed with candidemia and/or invasive candidiasis in 132 clinical sites across 18 countries. Study sites in China are recruiting patients for submission of rezafungin to the Center for Drug Evaluation. ReSTORE evaluated one 400 milligram (mg) dose of rezafungin for the first week followed by 200 mg of rezafungin dosed once-weekly for up to four weeks in total. The treatment arm was compared to approved daily dosing of caspofungin in a 1:1 randomization.

Summary of topline efficacy results:

Rezafungin once-weekly
400mg Wk1/200mg

N=93 (mITT)

n (%)

Caspofungin once-daily
70mg D1/50mg

N=94 (mITT)

n (%)

95% CI

Primary Endpoints

Day 30 All-Cause Mortality (FDA)

22 (23.7)

20 (21.3)

2.4 (-9.7, 14.4)

Day 14 Global Cure (EMA)

55 (59.1)

57 (60.6)

-1.11 (-14.9, 12.7)

Secondary Endpoints

Day 5 Mycologic Eradication2

50/64 (78.1)

46/67 (68.7)

Day 5 Global Cure

52 (55.9)

49 (52.1)

Day 14 Mycologic Eradication2

46/64 (71.9)

47/67 (70.1)

Exploratory Endpoints

Day 1 Negative Blood Culture3

36/67 (53.7)

30/65 (46.2)

Day 2 Negative Blood Culture3

49/66 (74.2)

41/64 (64.1)

Median ICU Length of Stay3,4

5.0 days
(n=17)

14.5 days
(n=28)

1 Point estimate and confidence interval for the difference is adjusted for the randomization factors. 2 Patients with candidemia only. 3 Not powered for statistical comparison. 4 All patients in the ICU on day 1 or admitted to the ICU during the study included except for those who died prior to ICU discharge.

Summary of topline safety results:
Overall rates of adverse events and serious adverse events were comparable in patients receiving rezafungin and caspofungin. Rates of adverse events leading to study drug discontinuation were also similar for rezafungin and caspofungin.

Additional details from the ReSTORE dataset will be presented at upcoming medical meetings.

Investor conference call and webcast:
Cidara management will host an investor conference call and webcast at 8:30 a.m. EST today, December 14 to review the topline data.

Toll Free:

+1-877-407-0789

International:

+1-201-689-8562

Conference ID:

13725670

Webcast:

https://viavid.webcasts.com/starthere.jsp?ei=1519692&tp_key=509f
c6e13f

A replay will be archived on the Company’s website at www.cidara.com after the webcast.

Additional Phase 3 Trial Focused on Prophylaxis (Prevention)
The ongoing global Phase 3 ReSPECT trial (NCT04368559) evaluating rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic bone marrow transplants continues to enroll patients. In ReSPECT, rezafungin is dosed once-weekly and compared to a daily regimen containing multiple drugs including fluconazole, posaconazole and trimethoprim-sulfamethoxazole, for 90 days, at which time fungal-free survival will be measured (the primary outcome measure). The trial is enrolling adults with underlying conditions including acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome(s), lymphoma and aplastic anemia.

About Invasive Candidiasis
Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, mortality rates are as high as 40%.1 IC is characterized as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.2

About Rezafungin
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin has been designated a Qualified Infectious Disease Product (QIDP) with Fast Track status by the FDA, and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.3,4

About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About Mundipharma
Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do. For more information visit www.mundipharma.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to our expectations that the ReSTORE trial data will support an NDA submission in the U.S. and similar marketing authorization submissions in other countries; the potential timing of such submissions; and the likelihood that rezafungin, if approved, will be prescribed by physicians or included in formularies or treatment guidelines. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s pre-clinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of rezafungin development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

References:

1. Kullberg BJ, Arendrup MC. Invasive Candidiasis. N Engl J Med 2015; 373:1445-1456.
2. Cortes JA, Corrales IF. Invasive Candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/books/fungal-infection/invasive-candidiasis-epidemiology-and-risk-factors. Last accessed December 2020. 
3. U.S. Food & Drug Administration. Search Orphan Drug Designations and Approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=507215. Last accessed 7 December 2021
4. European Commission. Community Register of orphan medicinal products. Available at: https://ec.europa.eu/health/documents/community-register/html/o2385.htm. Last accessed 7 December 2021.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Patrick Bursey
LifeSci Communications
(203) 430-9545
pbursey@lifescicomms.com

MEDIA CONTACT (Ex-US and Japan)
Jan Milton-Edwards
Mundipharma
+44 7341 739 984
jan.milton-edwards@mundipharma.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Altasciences Chosen by Virpax Pharmaceuticals, Inc. to Conduct First-in-Human Study of Epoladerm™ for Chronic Pain Associated with Osteoarthritis of the Knee21.1.2022 17:00:00 CET | Press release

Altasciences is pleased to have been chosen by Virpax® Pharmaceuticals, Inc. (“Virpax”) (NASDAQ:VRPX) to conduct a first-in-human study of Epoladerm™ (diclofenac epolamine) for chronic pain associated with osteoarthritis of the knee. This treatment is supplied in a pre-filled device for administration as a topical spray film. The study will be conducted in Q2 2022 at Altasciences’ clinical pharmacology unit in Montreal, Canada. “We look forward to working with Altasciences to accelerate the development of this analgesic treatment and provide robust data in support of the 505(b)(2) FDA approval pathway,” stated Virpax’s Chairman & CEO, Anthony P. Mack. Virpax’s proprietary technology provides a pre-filled canister for the therapeutic application of a clear, fast-drying spray film that is thinner than a standard liquid bandage. This technology offers convenience and eliminates the need for messy creams or gels. Altasciences leverages decades of experience conducting first-in-human clinic

OMRON Healthcare Remote Patient Monitoring Services Win “Best of” Honors at CES 202221.1.2022 16:21:00 CET | Press release

OMRON Healthcare, Inc., the global leader in remote blood pressure monitoring and personal health technology, spotlighted its new remote patient monitoring services at the 2022 Consumer Electronics Show (CES) and won “Best of” honors for its offerings in the U.K. and U.S: Hypertension Plus by OMRON in the U.K. was selected as a TWICE Picks Awards winner for the 2022 TWICE, Residential Systems and TechRadar Pro Picks Awards VitalSight™ by OMRON in the U.S. was recognised as an INSIDER “Best of” CES selection These remote patient monitoring services gained recognition at the world’s largest innovation show as breakthrough health technology designed to foster greater active health condition management, strengthen the patient-physician connection, and guide behavior change to reduce health risks, while advancing the company’s mission of Going for Zero heart attacks and strokes. “OMRON developed Hypertension Plus as the first step toward transforming chronic care in the U.K., while VitalSig

Schlumberger Announces Fourth-Quarter and Full-Year 2021 Results21.1.2022 12:50:00 CET | Press release

Schlumberger Limited (NYSE: SLB) today reported results for the fourth-quarter and full-year 2021. Fourth-Quarter Results (Stated in millions, except per share amounts)Three Months EndedChangeDec. 31, 2021Sept. 30, 2021Dec. 31, 2020SequentialYear-on-yearRevenue* $6,225 $5,847 $5,532 6% 13% Income before taxes - GAAP basis $755 $691 $471 9% 60% Net income - GAAP basis $601 $550 $374 9% 61% Diluted EPS - GAAP basis $0.42 $0.39 $0.27 8% 56% Adjusted EBITDA** $1,381 $1,296 $1,112 7% 24% Adjusted EBITDA margin** 22.2% 22.2% 20.1% 2 bps 208 bps Pretax segment operating income** $986 $908 $654 9% 51% Pretax segment operating margin** 15.8% 15.5% 11.8% 31 bps 401 bps Net income, excluding charges & credits** $587 $514 $309 14% 90% Diluted EPS, excluding charges & credits** $0.41 $0.36 $0.22 14% 86% Revenue by Geography International $4,898 $4,675 $4,343 5% 13% North America* 1,281 1,129 1,167 13% 10% Other 46 43 22 n/m n/m $6,225 $5,847 $5,532 6% 13% *Schlumberger divested certain businesses i

ZuluTrade - World’s Largest Social Trading Platform Joins the Finvasia Group21.1.2022 12:08:00 CET | Press release

ZuluTrade is strongly positioned to become the biggest and the largest broker neutral social trading platform with acquisition by Finvasia Group. 2022 will see ZuluTrade strengthening its current capabilities and widen its product line by venturing into different markets and financial instruments. The expansion will include contemporary asset classes like cryptocurrencies and traditional asset classes like stocks and bonds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220120005780/en/ ZuluTrade - World’s Largest Social Trading Platform Joins the Finvasia Group (Graphic: Business Wire) ZuluTrade has been at the forefront of copy trading for more than a decade and has helped over a million investors across more than 100 countries trade a volume of over USD 2 trillion. ZuluTrade 2.0 Future plans include launching a more engaging social investing platform with enhanced social and technology features, built on ZuluTrade’s curre

Ipsen Nominates Karen Witts as New Independent Board Member21.1.2022 07:00:00 CET | Press release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220120006035/en/ Karen Witts (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) announced today the nomination of Karen Witts to its Board of Directors as independent member. Karen Witts was Group CFO at Compass Group Plc until October 2021. Compass is the world’s leading food service company, operating in 43 countries and employing more than 500k people. She was responsible for corporate strategy and planning, business performance management and reporting, financial reporting and control, tax and treasury activities, M&A, internal audit and enterprise risk management, investor relations, and led the digital and technology function. Prior to this, Karen was Group CFO at Kingfisher Plc, the international home improvement company. She has also held various senior strategic finance positions at companies including Vodafone Group Services Ltd, and BT Plc. She

Peru Is Presenting Itself at FITUR 2022 as a Bio-safe Destination, Committed to Outdoor Experiences21.1.2022 02:48:00 CET | Press release

Peru is in attendance at the 42nd edition of FITUR 2022 to position itself as a safe and ready destination for international travellers, motivating them to rediscover the South American country, reported the Comisión de Promoción del Perú para la Exportación y el Turismo [Peruvian Export and Tourism Promotion Commission] (PROMPERÚ). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220119005812/en/ Inauguration of the Peru stand at FITUR 2022 by the executive president of PROMPERÚ, Amora Carbajal. ©PROMPERÚ In line with its promotion and recovery strategy, Peru is presenting a delegation made up of 19 co-exhibitors in order to show off the best of its tourist offering in the nature, adventure and culture segments. Likewise, it announced its collaboration with the Asociación Española de Agencias de Incentivos – IdeMICE, in order to enhance the attributes of the destination in this segment. In addition, the executive president of

McAfee Continues to Provide Leading Online Protection to Consumers21.1.2022 02:40:00 CET | Press release

Today, McAfee Corp. (NASDAQ: MCFE, “McAfee”), a global leader in online protection, provided an update regarding its pure-play consumer offering and the previously announced divestiture of its enterprise business. In July 2021, McAfee completed the sale of its enterprise business. This transaction allowed McAfee to singularly focus on its consumer business and accelerate its strategy to be the leader in online protection for consumers. “McAfee continues to safeguard the privacy, security and identity of our consumers as the digital world evolves rapidly,” said Gagan Singh, Executive Vice President & Chief Revenue and Product Officer, McAfee. “We continue to stand firm that meaningful protection is a personal right for consumers and have recently rolled out major updates and industry firsts, including McAfee Total Protection and Protection Score, that look out for consumers online, including their privacy and identity.” The McAfee Enterprise business was purchased by Symphony Technology

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom