Candidiasis, Invasive

Approval triggered by positive results from ReSTORE Phase III clinical trial Payment will advance Cidara’s Cloudbreak platform for the development of drug-Fc conjugates (DFCs) SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults. This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the standard of care, caspofungin, dosed once daily. The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options. “The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With the payment we’ve received from this milestone, we remain committed to advancing our Cloudbreak platform to develop targeted immunotherapies for cancer patients.” Cidara is currently advancing its Cloudbreak drug-Fc conjugate (DFC) platform to design targeted immunotherapies that inhibit specific diseases while simultaneously engaging the immune system. Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells. An IND is anticipated this year. About Cidara Therapeutics Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit About REZZAYO® (rezafungin for injection) REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at . 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 whether an unmet medical need exists for rezafungin, and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. 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. 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. INVESTOR CONTACT: Brian Ritchie LifeSci Advisors 212-915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Veronica Eames LifeSci Communications 646-970-4682 veames@lifescicomms.com

CAMBRIDGE, England--( BUSINESS WIRE )--Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB). 1,2 The authorisation was based on positive results from the pivotal ReSTORE Phase III clinical trial which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. 2,3,4 These findings are supported by the STRIVE Phase II clinical trial and an extensive nonclinical development program. 3,4 ReSTORE, a multicentre, prospective, randomised and double-blind Phase III trial compared the efficacy and safety of intravenous rezafungin with intravenous caspofungin in eligible patients with invasive candidiasis. 2,3 The primary efficacy outcome was global response (confirmed by the Data Review Committee [DRC]) at day 14. 3 Global response was determined from clinical response, mycological response, and radiologic response (for qualifying subjects with invasive candidiasis). 2,3 Of the 187 patients in the modified intention-to-treat (mITT) population, 59.1% of patients in the rezafungin group (55/93) and 60.6% of patients in the caspofungin group (57/94) had a global response of cure at day 14 (weighted treatment difference −1.1% [95% CI −14.9, 12.7]. 2,3 Non-inferiority was to be concluded if the lower bound of the 95% confidence internal (CI) for the difference in Day 14 cure rates (rezafungin – caspofungin) was >-20%. 2 Rezafungin was generally well tolerated in clinical trials, to date very common adverse reactions include hypokalaemia, pyrexia, and diarrhoea. Common adverse reactions include anaemia, hypomagnesaemia, hypophosphataemia, hypotension, wheezing, vomiting, nausea, abdominal pain, constipation, erythema, and rash. Increased blood alkaline phosphatase, hepatic enzymes, alanine aminotransferase, aspartate aminotransferase and blood bilirubin were also common. Uncommon adverse events were hyperphosphataemia, hyponatraemia, phototoxicity, tremor and increased eosinophil count. There were spontaneous reports of urticaria (frequency not known). Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness. 2 Rezafungin may cause increased risk of phototoxicity. Eligible patients should be advised to avoid sun exposure and other sources of UV radiation without adequate protection during treatment and for 7 days after the last administration of rezafungin. 2 Invasive candidiasis , is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. 10,11 It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more. 12,13 It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays. 14 In the last 15 years there have been no new treatments and morbidity and mortality rates remain largely the same, indicating the need for alternative treatment options. 5-9,15 Professor P. Lewis White PhD, FECMM, FRCPath, Consultant Clinical Scientist and Head of the PHW Mycology Reference Laboratory, Honorary Professor, Cardiff University Centre for Trials Research said “ Invasive candidiasis remains a difficult-to-treat disease which has a significant impact on critically ill and immunocompromised patients. With limited advances in treating this condition over the past 15 years, today’s announcement is a positive step towards supporting eligible patients and could enable the healthcare professional community an alternative way to manage these patients with invasive candidiasis using a new, once-weekly intravenous treatment option .” “ This authorisation is a culmination of years of developing an additional treatment option for eligible adult patients suffering from invasive candidiasis and underscores our commitment to supporting management of infectious diseases, ” said Dr Ben David, Medical Director for Northern Europe at Mundipharma. Rezafungin has been granted Orphan Drug Designation (ODD) in GB for the treatment of invasive candidiasis in adults. 1 The MHRA grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 5 in 10,000 people in GB where no satisfactory method of diagnosis, prevention or treatment of the condition concerned exists, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. 16 *ENDS* 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. 14 Despite a number of available treatments, the mortality rate for patients with invasive candidiasis can be 40% or more. 13,14 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues. 17 About Rezafungin Rezafungin is a novel once-weekly echinocandin that has been developed for the treatment of invasive candidiasis in adults. 18 About Napp Napp Pharmaceuticals Limited is part of Mundipharma, 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 Future clinical trial data A second Phase III clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial) is currently being conducted. 18 Registered office addresses NAPP PHARMACEUTICALS LIMITED a company having its registered office at Cambridge Science Park, Milton Road, Cambridge CB4 0AB, England. MUNDIPHARMA RESEARCH LIMITED, a company having its registered office at Cambridge Science Park, Milton Road, Cambridge, CB4 0AB, England. ® REZZAYO is a Registered Trademark of Cidara Therapeutics, Inc, used under license. References 1. UK Medicines and Healthcare Products Regulatory Agency authorisation. Available at: https://www.gov.uk/government/news/rezzayo-approved-to-treat-adult-patients-with-invasive-candidiasis (last accessed February 2024) 2. REZZAYO ® Summary of Product Characteristics. 3. Thompson GR, et al. Lancet 2023;401(10370):49–59. 4. Thompson GR, et al. Lancet Infect Dis 2023; https://doi.org/10.1016/S1473-3099(23)00551-0 5. Ham YY, et al. Future Microbiology 2021;16(1):27–36. 6. CANCIDAS (formerly Caspofungin MSD) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/cancidas-previously-caspofungin-msd (last accessed February 2024). 7. Vfend (voriconazole) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/vfend (last accessed February 2024). 8. Ecalta (anidulafungin) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/ecalta (last accessed February 2024). 9. Mycamine (micafungin) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/mycamine (last accessed February 2024). 10. Pappas PG, et al. Nat Rev Dis Primers 2018;4:18026. 11. CDC. Invasive candidiasis. Available at: https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html (last accessed February 2024). 12. Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445–56. 13. Bassetti M, et al. Crit Care 2019;23(1):219. 14. Cortegiani A, et al. Cochrane Database Syst Rev 2016;2016:Cd004920. 15. Bassetti M, et al. J Antimicrob Chemother 2018; 73 Suppl 1: i14–i25 doi:10.1093/jac/dkx445. 16. UK Medicines and Healthcare Products Regulatory Agency, Guidance – Orphan medicinal products. Available at: https://www.gov.uk/guidance/orphan-medicinal-products-in-great-britain (last accessed February 2024). 17. Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed February 2024). 18. Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of invasive candidiasis. Available at https://www.mundipharma.com/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 (last accessed February 2024). Job code: UK-RZF-2300053 Date of preparation: February 2024

The UK MHRA approval follows approvals by the U.S. FDA and the European Commission Cidara is entitled to receive a milestone payment of approximately $2.8 million from Mundipharma Jan. 29, 2024 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults. “Today’s announcement by the MHRA expands treatment options to even more patients suffering from life-threatening invasive candidiasis infections globally,” said Taylor Sandison, M.D. M.P.H., Chief Medical Officer at Cidara. “Our team, in partnership with Mundipharma, is proud to help bring the first new treatment option in 15 years to patients with this disease.” This approval comes after positive results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care, daily-dosed caspofungin. Rezafungin’s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Rezafungin is already approved by the United States Food and Drug Administration (FDA) and European Commission (EC). Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. The company is entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval. Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA and EC approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. 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, the mortality rate for patients with invasive candidiasis is as high as 40%. 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. REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism. The content above comes from the network. if any infringement, please contact us to modify.