Melinta Therapeutics Announces IDWeek 2024 Presentations Focused on Melinta’s Portfolio of Commercial and Investigational Stage Products

Melinta Therapeutics Announces IDWeek 2024 Presentations Focused on Melinta’s Portfolio of Commercial and Investigational Stage Products

by | Oct 16, 2024 | headline, Press, Press Releases

October 16, 2024

Melinta Therapeutics Announces IDWeek 2024 Presentations Focused on Melinta’s Portfolio of Commercial and Investigational Stage Products

Press Release

PARSIPPANY, N.J.–October 16, 2024 – Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today, ten scientific presentations with data focused on Melinta’s portfolio of commercial and investigational stage products to be shared at Infectious Disease Week (IDWeek) 2024, Oct. 16-19, 2024, in Los Angeles, California.

IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP).

Details of the presentations are provided below. The complete program of titles and abstracts can be accessed on the IDWeek 2024 website at www.idweek.org.

Melinta and Alliance Partner Posters and Oral Presentations

 

Product and Presentation Type Date/Time/Location Title Poster Number

Rezafungin

(poster)

Friday, Oct 18

12:15 PM – 1:30 PM

 

 Activity of rezafungin against clinical isolates of uncommon species of candida spp. 1095

Rezafungin

(poster)

Friday, Oct 18

12:15 PM – 1:30 PM

 

 Week one outcomes of rezafungin vs caspofungin treatment for candidemia and invasive candidiasis (CIC): pooled analysis of two randomized trials exploring optimal echinocandin duration 1034

Cefepime-taniborbactam

(poster)

Friday, Oct 18

12:15 PM – 1:30 PM

 

 Cefepime-taniborbactam exhibits limited cross-resistance with ceftazidime-avibactam and ceftolozane-tazobactam against carbapenem-nonsusceptible enterobacterales and multidrug-resistant pseudomonas aeruginosa from the United States 2018-2022 1514

Cefepime-taniborbactam

(poster)

Friday, Oct 18

12:15 PM – 1:30 PM

 

 Assessment of cefepime-taniborbactam (FEP-TAN) transmembrane clearance (CLTM) in an Ex vivo continuous renal replacement therapy (CRRT) model 1218

Cefepime-taniborbactam

(poster)

Friday, Oct 18

12:15 PM – 1:30 PM

 

 Susceptibility of carbapenem-resistant enterobacterales (CRE) and carbapenem-resistant pseudomonas aeruginosa (CRPA) with and without carbapenemases to cefepime-taniborbactam and comparators: GEARS antimicrobial surveillance program, United States, 2018-2022 1521

Cefepime-taniborbactam

(poster)

Friday, Oct 18

12:15 PM – 1:30 PM

 

 Cefepime pharmacodynamics against pseudomonas aeruginosa evaluated in a chemostat infection model: do generalized cephalosporin targets translate? 1241

Oritavancin

(poster)

Thursday, Oct 17

12:15 PM – 1:30 PM

 

 Acute bacterial skin and skin structure infections: a comparison of outpatient one-hour infusion oritavancin and inpatient vancomycin use 735

Meropenem-vaborbactam

(poster)

Friday, Oct 18

12:15 PM – 1:30 PM

 

 

 Unlocking potentials: the impact of meropenem, meropenem-vaborbactam, and ceftazidime-avibactam in combatting carbapenem-resistant enterobacter cloacae in epithelial lining fluid and serum

 1258

Meropenem-vaborbactam

(poster)

Friday, Oct 18

12:15 PM – 1:30 PM

 

 Patient characteristics and clinical outcomes associated with meropenem/vaborbactam treatment in carbapenem-resistant enterobacterales pneumonia 1499
Meropenem-vaborbactam
(oral presentation)

Thursday, Oct 17

3:15-4:30pm

Room 403B

 

 

 Population pharmacokinetics of meropenem-vaborbactam in acutely ill hospitalized patients with various degrees of renal dysfunction Oral Presentation

 

About Melinta Therapeutics, LLC
Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). Melinta also licensed the U.S. commercial rights to the investigational agent cefepime-taniborbactam from Venatorx Pharmaceuticals in 2023. For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit www.melinta.com.

 

Melinta Media Contact:

Sharon Dilling
sdilling@melinta.com

 

Melinta Therapeutics Announces IDWeek 2024 Presentations Focused on Melinta’s Portfolio of Commercial and Investigational Stage Products

Melinta Therapeutics Announces the Appointment of Fabrizio Tondolo, MD, as Vice President of Medical Affairs

by | Aug 6, 2024 | headline, Press

August 6, 2024

Melinta Therapeutics Announces the Appointment of Fabrizio Tondolo, MD, as Vice President of Medical Affairs

Press Release

Parsippany, N.J. – August 6, 2024 – Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Dr. Fabrizio Tondolo as Vice President of Medical Affairs, effective today.

Dr. Tondolo is a distinguished Medical Affairs leader with a proven track record of successful medical and scientific advocacy and the translation of novel science into real-world clinical advances.

As an Executive Committee member reporting to Melinta’s President & CEO, Christine Ann Miller, Dr. Tondolo will be responsible for developing and implementing integrated medical plans for Melinta’s portfolio. Additionally, Dr. Tondolo will help Melinta stand out as a thought leader in the important conversations happening in scientific and medical communities.

“We are thrilled to welcome Fabrizio as Vice President of Medical Affairs at Melinta,” said Christine Ann Miller, President and CEO, of Melinta Therapeutics. “His robust scientific knowledge, extensive experience in people and business management, and unwavering passion for innovation make him an invaluable addition to our team. Fabrizio’s background in the acute care setting and his deep commitment to patient care align perfectly with our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses.”

Dr. Tondolo received his MD degree at the University of Bologna and was a practicing physician before joining Merck in 1995. There, he worked in roles of growing managerial responsibility across different functions including sales, marketing, business development, medical affairs, and different therapeutic areas, with a particular focus on acute care and infectious diseases. In 2020, he was appointed to lead the transition team to set up the medical affairs organization for the spin-off of Organon, where most recently he acted as head of Global Medical Affairs and Outcomes Research.

“I am thrilled to join this incredible team at Melinta, where passion and purpose drive every endeavor,” said Tondolo. “This opportunity to contribute to a company with such a clear vision – that everyone who needs our therapies will receive them – is truly inspiring. I look forward to working with our talented team to advance our mission and make a meaningful impact on patients’ lives.”

About Melinta Therapeutics 

Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit Melinta.com.   

 

Melinta Media Contact:

Sharon Dilling
sdilling@melinta.com

Melinta Therapeutics Announces IDWeek 2024 Presentations Focused on Melinta’s Portfolio of Commercial and Investigational Stage Products

Melinta Therapeutics Announces Publication of the Outcomes by Candida Species from the ReSTORE Phase 3 trial and Recently Approved Rezafungin CLSI Breakpoints for Candida glabrata and Candida auris

by | May 23, 2024 | headline, Press, Press Releases

May 23, 2024

Melinta Therapeutics Announces Publication of the Outcomes by Candida Species from the ReSTORE Phase 3 trial and Recently Approved Rezafungin CLSI Breakpoints for Candida glabrata and Candida auris

Press Release

Publication reaffirms the efficacy of rezafungin for treatment of candidemia and invasive candidiasis (IC) in adult patients across Candida species

PARSIPPANY, NJ—May 23, 2024— Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups.

The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections.  Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials. 

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, “We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C. auris, which has been identified as a potential global threat by the CDC and WHO.”

She added, “Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses.”

Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma.  

 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.

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

Contraindications

REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

Warnings and Precautions

  • Infusion-related Reactions: 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.
  • Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
  • Hepatic Adverse Reactions: 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.

Adverse Reactions

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 www.rezzayo.com.

About Melinta Therapeutics, LLC
Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit www.melinta.com.

 

 

 

Melinta Therapeutics Announces IDWeek 2024 Presentations Focused on Melinta’s Portfolio of Commercial and Investigational Stage Products

Melinta Therapeutics Announces Appointment of Doug Girgenti as Vice President of Drug Development

by | Oct 21, 2021 | Press, Press Releases

October 25, 2021

Melinta Therapeutics Announces Appointment of Doug Girgenti as Vice President of Drug Development

Press Release

Melinta Therapeutics Announces Appointment of Doug Girgenti as Vice President of Drug Development

MORRISTOWN, N.J., Oct. 25, 2021 — Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Dr. Doug Girgenti as Vice President of Drug Development, effective today.

Dr. Girgenti, a global leader in clinical research and drug development, joins Melinta under the leadership of President and Chief Executive Officer Christine Ann Miller. With the addition of Dr. Girgenti, Melinta expects to expand its world-class portfolio while continuing to drive operational excellence.

“At Melinta, we’re on a legendary journey to become the leader in acute care and continue to serve patients with critical, unmet needs. I’m excited to welcome Doug to the team as a seasoned leader with extensive medical, scientific and operational experience,” Ms. Miller said. “I’m confident he’ll play a key role as we evaluate potential assets to expand our portfolio and help lead our team to meet clinical, operational, regulatory and financial objectives.”
Dr. Girgenti joins Melinta from Magenta Therapeutics where he led clinical development programs for stem-cell mobilization and autoimmune diseases. Prior to Magenta, Dr. Girgenti led global clinical programs for Wyeth, Pfizer and Boehringer-Ingelheim developing investigational vaccines targeting Staphylococcus aureus and invasive pneumococcal disease as well as numerous small and large molecules in the fields of immunology, stem-cell transplantation, nephrology, ophthalmology, cardiology and rare diseases.
Prior to joining the pharma industry, he was a practicing pediatrician and internist for 10 years, and he served as a medical director and managing physician of multiple medical and surgical subspecialists.
“I’m excited to join this team that is so passionately committed to patients in need,” Dr. Girgenti said. “I look forward to helping lead the way for more sustainable growth through clinical and developmental success while keeping patients at the center of our legendary future.”

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes five commercial-stage antibiotics: Baxdela® (delafloxacin), Kimyrsa™ (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), and Vabomere® (meropenem and vaborbactam). With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Visit www.melinta.com for more information.
Contact Information
Susan Blum
(312) 767-0296
info@melinta.com

 

Jisoo Park

Jisoo Park

by | Oct 2, 2021 | Leaders

Jisoo Park

Chief Business Officer

Jisoo is a global pharmaceutical business development leader with a proven track record. Previously, Jisoo served as Vice President of Business Development and M&A at Covis Pharma. At Covis, Jisoo led global business development and M&A, including transformational buy-side and sell-side M&A, licensing and financings. In less than five years, Jisoo led seven deals worth roughly $2 billion in transaction value, helping expand the organization beyond the U.S. and into more than 50 markets.

Prior to Covis, he was an investment banker in J.P. Morgan’s Global Healthcare team in New York and San Francisco, where he advised companies in the pharmaceuticals, biotech and life sciences industries on M&A, equity and debt financings.

He holds a B.S. in Economics and Statistics from Carnegie Mellon University.

“Melinta is on a mission to make the most meaningful impact for patients with life-threatening illnesses and I’m excited to join the team in the middle of such great momentum. I look forward to working with this truly committed team toward continued growth and expansion to serve patients in need in the U.S. and beyond.”

Melinta is on a mission to make the most meaningful impact for patients with life-threatening illnesses and I’m excited to join the team in the middle of such great momentum. I look forward to working with this truly committed team toward continued growth and expansion to serve patients in need in the U.S. and beyond.

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