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Arix Bioscience Plc - Amplyx announces positive Phase 2 data

Arix Bioscience plc

Amplyx announces positive Phase 2 data

(LSE:ARIX) ("Arix"), a global venture capital company focused on investing in and building breakthrough biotech companies, notes that its portfolio company, , (“Amplyx”), today announced positive topline data following the completion of its Phase 2 clinical trial of fosmanogepix as a first-line treatment for patients with invasive fungal infections caused by Candida. The trial met its primary efficacy endpoint, demonstrating a treatment success rate of 80%. Fosmanogepix was well tolerated with no treatment-related serious adverse events or discontinuations., :LONDON20 July 2020Arix Bioscience plcAmplyx Pharmaceuticals

The announcement can be accessed on Amplyx’s website at and full text of the announcement from Amplyx is contained below.https://amplyx.com/investors/#latest_news

[ENDS]

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AboutArix Bioscience plc

is a global venture capital company focused on investing in and building breakthrough biotech companies around cutting edge advances in life sciences. We collaborate with exceptional entrepreneurs and provide the capital, expertise and global networks to help accelerate their ideas into important new treatments for patients. As a listed company, we are able to bring this exciting growth phase of our industry to a broader range of investors.Arix Bioscience plc

is listed on the Main Market of the . For further information, please visitArix Bioscience plcLondon Stock Exchangewww.arixbioscience.com

Amplyx Announces Positive Top-line Data in Phase 2 Clinical Trial of Novel Antifungal Fosmanogepix

CandidaFosmanogepix met primary efficacy endpoint and demonstrated favorable safety profile in first-line treatment of invasiveinfections

– – , a clinical-stage biopharmaceutical company developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, today announced positive topline data following the completion of its Phase 2 clinical trial of fosmanogepix as a first-line treatment for patients with invasive fungal infections caused by . The trial met its primary efficacy endpoint, demonstrating a treatment success rate of 80%. Fosmanogepix was well tolerated with no treatment-related serious adverse events or discontinuations. In addition, fosmanogepix demonstrated potent  activity against all  isolates obtained from patients in this study, including isolates resistant to other antifungal agents. More detailed results from the trial will be presented at an upcoming medical meeting.SAN DIEGO  July 20, 2020 Amplyx PharmaceuticalsCandidain vitro Candida

“We are very encouraged that fosmanogepix demonstrated a high rate of treatment success, including activity against resistant pathogens, and was well tolerated in patients with invasive  infections. Importantly, patients were able to easily transition from intravenous to oral formulations during their treatment,” said , M.D., chief medical officer of Amplyx. “The positive efficacy and safety data from this trial continue to highlight the promise of fosmanogepix as a novel and differentiated treatment option for patients who develop life-threatening invasive fungal infections. We look forward to advancing the fosmanogepix program in invasive candidiasis towards registration, while continuing our proof-of-concept clinical trials in other invasive fungal infections, including invasive aspergillosis.”Candida Michael R. Hodges

Amplyx is developing fosmanogepix, a broad-spectrum, oral and intravenous antifungal, representing a novel therapeutic class with the potential to treat pathogens resistant to current available antifungal agents. Additional Phase 2 studies of fosmanogepix are ongoing in patients with serious and life-threatening  and rare mold infections, as well as infections caused by drug-resistant . In 2019, the recognized drug-resistant  as an urgent threat to global public health, other drug-resistant  strains as serious threats, and the emergence of drug-resistant  added to the watch list for global health threats, underscoring the need for innovation in the development of antifungals, especially those with a novel mechanism of action.Aspergillus Candida aurisC. aurisCandidaAspergillusU.S. Centers for Disease Control

“There is a dire need for safe and effective new antifungal agents as there have been no new drugs approved in the past two decades, coupled with the growing number of immunocompromised patients who are at increased risk for developing these life-threating infections,” said , M.D., professor of medicine, division of infectious diseases, . “Fosmanogepix has the potential to be the first in a new class of antifungal agents and an important addition to the treatment armamentarium for patients with difficult-to-treat and deadly invasive fungal infections. The current pandemic has highlighted how devastating infectious diseases can be and reinforces the need for new and novel anti-infective agents capable of combating emerging threats.”Peter PappasUniversity of Alabama at Birmingham

About the Phase 2 Trial

This was a multicenter, open-label, non-comparative, single-arm study evaluating the efficacy and safety of fosmanogepix for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 years of age and older. Patients were treated with fosmanogepix for up to 14 days: 1000 mg intravenously twice a day for one day, then 600 mg intravenously once daily for at least two days, followed by either 600 mg intravenously once daily or 700 mg orally once daily. Short-term fluconazole (or susceptibility-appropriate alternative) could follow if completion of the treatment course was required beyond 14 days. The primary efficacy endpoint was outcome at end of study treatment (EOST) as determined by the independent data review committee (DRC). Successful outcome was defined as clearance of  from blood cultures with no additional antifungal treatment and survival at EOST. All  isolates were tested for susceptibility. A key secondary efficacy endpoint was survival at Day 30.CandidaCandida

The trial enrolled 21 patients, and 20 patients were included in the modified intent-to-treat, or mITT, population. The DRC assessed 16/20 (80%) patients as treatment success at EOST. Further, 18/21 (86%) of the patients where alive at Day 30. Fosmanogepix was safe and well tolerated with no treatment related SAEs or discontinuations.

Identifier: NCT03604705ClinicalTrials.gov

About Invasive Fungal Infections

Invasive fungal infections (IFIs) represent a serious threat to millions of patients worldwide, resulting in more than 1.5 million deaths annually and mortality rates ranging from 15% to 65%.  These infections continue to be a global health issue, especially for critically ill patients in hospitals and patients with compromised immune systems, including cancer and transplant patients.

About Fosmanogepix

Fosmanogepix, is a novel, broad-spectrum antifungal agent being evaluated in multiple clinical trials in patients with life-threatening fungal infections.  Fosmanogepix demonstrated a high level of treatment success (80%) in a Phase 2, proof-of-concept study as first-line treatment of infections caused by .  Additional Phase 2 studies of fosmanogepix are ongoing in patients with  and rare mold infections, as well as infections caused by multi-drug-resistant , a life-threatening fungal infection recently characterized as an “urgent” threat by the Centers of Disease Control ().CandidaAspergillus Candida aurisCDC

Fosmanogepix has a novel mechanism of action, and its active moiety has shown broad-spectrum activity against common species of  and , including multi-drug resistant strains, such as  and , as well as rare, hard-to-treat molds including  and some fungi from the Mucorales order. Invasive fungal infections result in high mortality rates (30-80%), despite standard-of-care treatment. The frequency of fungi resistant to both the azole and echinocandin classes of drugs is increasing and there is a significant unmet medical need for a new, broad-spectrum antifungal agent.Candida AspergillusC. aurisC. glabrataFusarium, Scedosporium

Fosmanogepix has received  and Orphan Drug designations from the for seven separate indications and is also designated as a Qualified Infectious Disease Product (QIDP) for the treatment of four indications.Fast TrackUS FDA

AboutAmplyx Pharmaceuticals

is developing innovative therapies for patients with compromised immune systems, including cancer and transplant patients, and the critically ill. The company’s two lead products are fosmanogepix (APX001), a first-in-class antifungal, for the treatment of life-threatening fungal infections caused by pathogens such as ,  and rare molds, and MAU868, a novel human monoclonal antibody that potently neutralizes the BK virus, which can cause significant morbidity and mortality in transplant patients. For more information, please visit Amplyx PharmaceuticalsCandidaAspergillus www.amplyx.com

Contact:

, Ph.D. Managing Director (619) 203-5391Heidi Chokeir



Canale Communications[email protected]

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