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Viewpoints_Dr. Changjin Wang
VIEWPOINTS

Dr. Changjin Wang, CEO at Frontier Biotechnologies, Shares Insights on P-I Results of its Coronavirus Mpro Inhibitor

Shots: Changjin spoke about the P-I results of their lead candidate, Bofutrelvir to treat acute and long covid. The data was presented at the poster session of the 11th International Conference on ICEID, 2022 Changjin also talked about the upcoming formulations of this innovative medicine and the initiation of its BRIGHT study covering the P-II/III…
September 19, 2022

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Viewpoints_Tania Small
VIEWPOINTS

Tania Small, VP, Global Medical Oncology Head, GSK, Shares Insights on Target the Future Think Tank Challenge

Shots: Tania spoke about the Target the Future Think Tank Challenge and how it will advance and address key needs in the multiple myeloma  She also talked about GSK’s collaboration with the HealthTree Foundation to provide access, education, and support for underserved communities of multiple myeloma The interview gives a profound understanding of how GSK…
September 14, 2022

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ThoughtSpot_Senior Editor
THOUGHTSPOT

ILAP and its nuance vs PRIME since BREXIT

Introduction PRIME (PRIority MEdicines) EMA launched PRIME on March 07, 2016, to support the development of medicines targeting unmet medical needs. The scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients faster. PRIME builds on the…
September 13, 2022

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Viewpoints_Matt Killeen
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Matt Killeen, CSO at Renovacor Shares Insights on Pipeline Expansion through its AAV Gene Therapy Program

Shots: Matt spoke about the new research program for multiple genetic segments of arrhythmogenic cardiomyopathy He also highlighted Renovacor’s research collaboration with the University of Utah’s Nora Eccles Harrison Cardiovascular Research and Training Institute (CVRTI) The interview shows Renovacor’s pipeline expansion to develop transformative therapies in genetically-driven cardiovascular diseases Smriti: Please give readers a brief insight…
September 12, 2022

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Viewpoints_Carsten Linnemann
VIEWPOINTS

Carsten Linnemann, CEO at Neogene Therapeutics Shares Insights on the Approval of CTA for the P-I Trial of its TCR Therapy to Treat Solid Tumors

Carsten spoke about the approval of CTA by the Dutch regulatory authority for a P-I study evaluating its TCR therapy for the treatment of solid tumors Carsten also emphasized how NT-125 will be different from other TCR therapies The interview shows the advancement of Neogene’s pipeline developing transformative TCR therapies targeting neoantigens in solid cancers…
September 7, 2022

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John Strickler, Associate Professor of Medicine, Duke University School of Medicine, Shares Insights from the P-II Study at the 2022 ESMO World Congress on Gastrointestinal Cancer
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John Strickler, Associate Professor of Medicine, Duke University School of Medicine, Shares Insights from the P-II Study at the 2022 ESMO World Congress on Gastrointestinal Cancer

Shots: John spoke about the results from the P-II MOUNTAINEER Trial evaluating its lead candidate in mCRPC He also talked about TUKYSA (tucatinib) in combination with trastuzumab as a potential treatment for mCRPC The interview gives a deeper understanding of Seagen’s vision of developing transformative cancer treatment options Smriti: Share the details (ROA, MOA & formulations)…
September 6, 2022

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George Stanley, Medical Director for the UK & Ireland at BioCryst Shares Insights from Long-Term Study Data at EAACI 2022
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George Stanley, Medical Director for the UK & Ireland at BioCryst Shares Insights from Long-Term Study Data at EAACI 2022

Shots: George spoke about the 96-week data from the P-III APeX-2 trial evaluating BioCryst’s lead candidate in Hereditary Angioedema (HAE)  He also talked about various patient support programs from BioCryst to help patients with self-management of their HAE The interview gives an understanding of BioCryst’s vision to develop medicines that treat rare diseases for unmet…
August 31, 2022

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Shots: Jeff talked about the results from the P-III ReSTORE Trial evaluating rezafungin in the treatment of candidemia/invasive candidiasis at ECCMID 2022 Jeff also spoke about Cidara’s collaboration with Mundipharma for the commercialization of Rezafungin The interview sheds light on Cidara’s vision to develop transforming treatments to improve the standard of care for patients facing serious diseases Smriti: Please give our readers a comparative view of P-II (STRIVE) vs P-III (ReSTORE) evaluating Rezafungin Jeff Stein: Both P-II (STRIVE) and P-III (ReSTORE) evaluated the safety and efficacy of rezafungin in the treatment of candidemia and/or invasive candidiasis against the current standard of care, caspofungin. STRIVE assessed the safety, tolerability, and efficacy of two different once-weekly dosing regimens for intravenous rezafungin versus standard once-daily dosing of intravenous caspofungin. These data informed the dosing regimen for patients in the ReSTORE trial. The results from both trials were positive. The Phase 3 ReSTORE trial demonstrated non-inferiority of once-weekly rezafungin to once-daily caspofungin for each primary endpoint: all-cause mortality on day 30 for the U.S. FDA (23.7% for rezafungin vs 21.3% with caspofungin) and global cure at day 14 for the EMA (59.1% for rezafungin vs 60.6% for caspofungin). An integrated analysis of the STRIVE and ReSTORE trials (pooled data from both trials), which together provide the basis for approval, showed additional positive results, including 18.7% for all-cause mortality on day 30 with rezafungin vs 19.4% with caspofungin, 60.0% for negative blood culture at 24 hours with rezafungin vs 49.1% with caspofungin, and at 48 hours 77.7% with rezafungin vs 63.5% with caspofungin. An intriguing trend that was observed in both the STRIVE and ReSTORE studies was that patients on rezafungin were discharged from the ICU earlier than patients who received caspofungin. In STRIVE, patients on rezafungin spent a median of five fewer days in the ICU than patients who received caspofungin. In ReSTORE, the difference nearly doubled with patients on rezafungin spending a median of 9.5 fewer days in the ICU than patients who received caspofungin. This difference was captured as a prespecified exploratory endpoint in the ReSTORE study. In both STRIVE and ReSTORE trials, safety, and tolerability outcomes were consistent with the safety profiles of both rezafungin and caspofungin. Smriti: How have the results from P-II (STRIVE) & P-III (ReSTORE) clinical trials affected Rezafungin’s potential to become the first treatment option for candidemia/invasive candidiasis in a long time? Jeff Stein: Innovation in the space has indeed been slow, despite the need for additional treatment options for critically ill patients suffering from candidemia and/or invasive candidiasis. This fact underscores the importance of these trials. Our Phase 3 ReSTORE trial demonstrated that rezafungin dosed once-weekly is non-inferior to the current standard of care, caspofungin, dosed once-daily. Data from our Phase 2 STRIVE trial show that rezafungin met its objectives for safety, efficacy, and tolerability in treating patients with candidemia and/or invasive candidiasis and was statistically superior to caspofungin on time to negative blood culture (speed of clearing Candida from the blood). If approved, rezafungin could become the first new treatment option for these patients in over a decade, and the first-ever once-weekly echinocandin. Smriti: Explain the details (MOA, ROA, formulations, etc.) of Rezafungin Jeff Stein: Rezafungin is a next-generation echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. Rezafungin is an antifungal in the echinocandin class, a group of molecules that are known for their strong safety profile and minimal drug-drug interactions. It acts by inhibiting the synthesis of the polysaccharides that make up the fungal cell wall, preventing the growth of the fungus. Rezafungin’s long half-life allows for once-weekly intravenous dosing instead of once-daily intravenous dosing with the current standard of care, caspofungin. Rezafungin’s structure and its properties are specifically engineered to preserve its safety advantages and improve pharmacology to treat fungal infections. Smriti: Shed some light on your collaboration with Mundipharma. Jeff Stein: In 2019, we entered into a strategic partnership with Mundipharma in a deal valued at $568 million plus double-digit royalties in the teens on tiers of annual net sales, to develop and commercialize rezafungin. Under the terms of the agreement, Mundipharma has exclusive commercialization rights to rezafungin outside the U.S. and Japan. Smriti: Can we talk about the reason why Cidara chose Caspofungin for the comparative study of Rezafungin? Jeff Stein: As mentioned above, caspofungin dosed once daily is the current standard of care for patients with candidemia and/or invasive candidiasis. In the ReSTORE trial, data demonstrated non-inferiority of once-weekly rezafungin to once-daily caspofungin. Smriti: Give us a brief understanding of what makes the PK/PD profile of Rezafungin unique and how it helps towards quicker fungal clearance for patients Jeff Stein: While rezafungin is an echinocandin, its structure has been engineered for enhanced stability and safety. These improvements allow rezafungin to be dosed once weekly and enable higher amounts of the drug to get into the bloodstream faster, which in turn leads to more rapid clearance of Candida from the blood than standard echinocandins. This was corroborated in both the STRIVE and ReSTORE clinical trials. Smriti: What are your plans for the approval of Rezafungin? Jeff Stein: In July, we announced that we submitted an NDA to the FDA for rezafungin for the treatment of candidemia and invasive candidiasis. The NDA submission was based on positive results from the global ReSTORE Phase 3 and STRIVE Phase 2 trials. We expect to be assigned a PDUFA target action date in the first quarter of 2023 if the NDA is accepted for review following application validation. Additionally, we announced that we entered into a license agreement with Melinta Therapeutics under which Cidara granted Melinta an exclusive license to commercialize rezafungin in the U.S. in a deal valued at $460 million plus low double digits to mid-teens royalties on net sales. We are currently assessing the efficacy of rezafungin for the prevention of invasive fungal disease through our ongoing Phase 3 ReSPECT clinical trial in patients who are undergoing allogeneic blood and marrow transplantation. Source: Canva About the Author: Dr. Stein is the President, CEO, and Director at Cidara Therapeutics. Dr. Stein holds a B.S. in marine biology and an M.S. in Biology from California State University—Long Beach and a Ph.D. in Biochemistry and Molecular Biology from the University of California, San Diego. Dr. Stein conducted his postdoctoral research as an Alexander Hollaender Distinguished Postdoctoral Fellow at the California Institute of Technology. He has also served as a Principal Scientist with Diversa Corporation and the Agouron Institute. Related Post: PharmaShots Interview: In Conversation with Cidara’s CEO, Dr.Jeff Stein, Where he Shares Insights on the IND acceptance by the FDA to Treat Influenza
VIEWPOINTS

Jeff Stein, President & CEO of Cidara Therapeutics Shares Insights on the P-III ReSTORE Trial of Rezafungin to Treat Candidemia

Shots: Jeff talked about the results from the P-III ReSTORE Trial evaluating rezafungin in the treatment of candidemia/invasive candidiasis at ECCMID 2022 Jeff also spoke about Cidara’s collaboration with Mundipharma for the commercialization of Rezafungin  The interview sheds light on Cidara’s vision to develop transforming treatments to improve the standard of care for patients facing…
August 30, 2022

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Rami Apelian and Marija Geertsen Share Insights from 9 Poster Presentations on Migraine Prevention & Treatment at AHS 2022
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Rami Apelian and Marija Geertsen Share Insights from 9 Poster Presentations on Migraine Prevention & Treatment at AHS 2022

Shots: Rami spoke about study design of the P-III study evaluating its lead candidate in migraine Marija Geertsen talked about different treatment options available for migraine & neurological diseases The interview highlights the development plans and global expansion of various therapies for brain diseases Smriti: Explain the details (MOA, ROA, formulations, etc.) of Vyepti. Rami Apelian: VYEPTI®…
August 29, 2022

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