Amplyx Doses First Patient in Phase 2 Clinical Trial of Anti-BKV Monoclonal Antibody in Renal Transplant Recipients

Amplyx Doses First Patient in Phase 2 Clinical Trial of Anti-BKV Monoclonal Antibody in Renal Transplant Recipients

SAN DIEGO, Aug. 17, 2020 — Amplyx Pharmaceuticals, a clinical-stage biopharmaceutical company developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, today announced that the first patient has been dosed in its Phase 2 clinical trial evaluating the efficacy and safety of MAU868 for the treatment of BK viremia in kidney transplant recipients. MAU868 is a novel, human monoclonal antibody that potently neutralizes all four major genotypes of BK virus (BKV). BKV-associated nephropathy is a leading cause of kidney allograft loss.

Amplyx Pharmaceuticals Adds Pfizer and Adage to Series C Financing, Bringing Total to over 90 Million

SAN DIEGOMay 19, 2020Amplyx Pharmaceuticals, a biotech company developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, today announced that it has closed a $53 million Series C extension, which brings the Series C round to over $90 million. The financing was led by Sofinnova Investments, with participation from existing investors including New Enterprise Associates, Lundbeckfonden Ventures, Arix Bioscience, Pappas Capital, RiverVest Venture Partners, 3×5 Partners and BioMed Ventures. New equity investment from Pfizer Inc. (NYSE: PFE) and Adage Capital Management completed the financing round. Amplyx will use the proceeds of the financing to advance the clinical development of the company’s product candidates, fosmanogepix and MAU868.

Amplyx Pharmaceuticals Advances Development of Novel Antifungal, Fosmanogepix

SAN DIEGOMay 19, 2020Amplyx Pharmaceuticals, a biotech company developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced today that it has advanced development of its lead program, fosmanogepix (APX001). Enrollment has been completed in a Phase 2 trial evaluating the safety and efficacy of fosmanogepix for the treatment of infections caused by Candida. Top-line data from the trial is expected by July; the results of an initial analysis of the first 10 patients enrolled showed a high level of treatment success. The first patients have also completed treatment in two additional Phase 2 clinical trials evaluating the safety and efficacy of fosmanogepix (APX001) for the treatment of invasive mold infections caused by Aspergillus and rare molds, as well as a study of invasive candidiasis caused by Candida auris, an emerging, life-threatening, drug-resistant fungal pathogen.

Amplyx Pharmaceuticals Licenses Phase 2 Drug Candidate for BK Viral Disease in Transplant Patients

SAN DIEGOSept. 16, 2019 — Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced today that it has executed an exclusive worldwide license agreement with Novartis under which Amplyx has acquired the rights to the Phase 2 anti-BK virus (BKV) monoclonal antibody, MAU868, for the treatment and prevention of BKV disease. Financial terms have not been disclosed.

Amplyx Pharmaceuticals Announces Positive Preliminary Data from Ongoing Fosmanogepix Phase 2 Study in Candidemia

SAN DIEGOSept. 16, 2019 — Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced today that two independent review committees completed their planned safety and efficacy assessment of data from 50% of the planned study population enrolled in the Company’s Phase 2 open-label clinical trial of fosmanogepix (APX001) for the treatment of candidemia.

 

FDA Grants Fast Track Status to Amplyx Pharmaceuticals for Fosmanogepix

SAN DIEGOSept. 9, 2019 — Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced today that the U.S. Food & Drug Administration (FDA) has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company’s lead antifungal candidate, fosmanogepix (APX001), for seven indications. These indications include treatment of invasive candidiasis, treatment of invasive aspergillosis, treatment of scedosporiosis, treatment of fusariosis, treatment of mucormycosis, treatment of cryptococcosis and treatment of coccidioidomycosis. Amplyx is investigating the safety and efficacy of fosmanogepix in its ongoing global Phase 2 clinical program.

Amplyx Pharmaceuticals Receives Fourth “Qualified Infectious Disease Product” (QIDP) Designation from the FDA for APX001

San Diego, CA, Mar. 19, 2018 – Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, including deadly fungal pathogens, today announced that the US Food and Drug Administration (FDA) has granted a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, the company’s lead antifungal product candidate. The QIDP designation, a provision under the U.S. Generating Antibiotic Incentives Now (GAIN) Act, was approved by Congress in 2012 to offer incentives to companies to bring to market new treatments for deadly infections. These incentives provide APX001 with eligibility for priority FDA review and fast-track status, and an additional five years of market exclusivity under the Hatch-Waxman Act. Amplyx had previously received QIDP designation as well as orphan drug designation from the FDA for APX001 for the treatment of invasive candidiasis, invasive aspergillosis, and coccidioidomycosis. This new QIDP status expands the eligible population to include the treatment of cryptococcosis.

Amplyx Pharmaceuticals Raises $67 Million in Series C Financing

San Diego, CA, Aug 2, 2017 – Amplyx Pharmaceuticals, a company developing novel antifungal agents for life-threatening fungal infections, today announced that it has raised $67 million through a Series C financing led by Sofinnova Venture Partners and including other new investors Lundbeckfonden Ventures, Arix Bioscience and Pappas Capital. Existing investors New Enterprise Associates, RiverVest Venture Partners, 3×5 RiverVest II and BioMed Ventures also participated in the financing. In conjunction with the financing, Anand Mehra, M.D., managing partner at Sofinnova Ventures, and Johan Kördel, Ph.D., senior partner at Lundbeckfonden Ventures, will join the Amplyx board of directors.