Positive clinical progression in Group Businesses

Arix Bioscience plc

Positive clinical progression in Group Businesses

Further expansion of Arix pipeline with three new clinical trials initiated

LONDON, 10 August 2018: Arix Bioscience plc ("Arix") (LSE: ARIX), a global healthcare and life science company supporting medical innovation, is pleased to note the positive clinical progression in its following three Group Businesses – Iterum Therapeutics plc (“Iterum”) (Nasdaq: ITRM), Harpoon Therapeutics, Inc (“Harpoon”) and Verona Pharma plc (“Verona”) (AIM: VRP) (Nasdaq: VRNA).

• Iterum Therapeutics, a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, initiated a Phase 3 clinical trial of oral sulopenem in uncomplicated urinary tract Infections, the first of three planned Phase 3 pivotal trials.  Sulopenem is Iterum’s lead compound and novel oral antibiotic for the treatment of gram-negative, multi-drug resistant infections. If approved, this could be the first antibiotic for uncomplicated urinary tract infections in over 20 years and would provide a much-needed treatment option in a large and growing market. Top-line results are expected in 2H 2019 and NDA submission anticipated by the end of 2019.

• Harpoon Therapeutics, an immuno-oncology company pioneering a new class of T cell engaging therapeutics, treats first patient with HPN424 in its Phase 1 clinical study of metastatic castration-resistant prostate cancer (mCRPC) patients. This is an important milestone for Harpoon as it transitions to a clinical stage company.

• Verona Pharma, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, has initiated a Phase 2 clinical trial to evaluate Nebulized RPL554 as an add on to Dual Bronchodilator Therapy for COPD Maintenance Treatment. Top line data is expected in Q1 2019.

Commenting on the news, Joe Anderson, CEO of Arix Bioscience, said: “We are pleased to note the initiation of new trials by Iterum Therapeutics, Harpoon Therapeutics and Verona Pharma. These are important milestones for the companies that showcase innovative science across all stages of development, and represent positive progression in our core portfolio.

“These companies have the potential to create important new treatments for patients and we look forward to providing further expertise and capital support to enable them to progress their products to market.”

Group Business press releases

Please find links to the Iterum Therapeutics, Harpoon Therapeutics and Verona Pharma announcements below.

Iterum Initiates SURE 1, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

DUBLIN and CHICAGO, August 9, 2018 -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the first of three Phase 3 clinical trials. In this trial, known as Sulopenem for Resistant Enterobacteriaceae (SURE) 1, oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to oral ciprofloxacin in women with uncomplicated urinary tract infections (uUTI). Sulopenem is Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant infections.

Press release available here: https://www.iterumtx.com/news/press-releases

Harpoon Therapeutics Treats First Patient with HPN424 in Phase 1 Clinical Trial of Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients  

South San Francisco – August 6, 2018 – Harpoon Therapeutics, an immuno-oncology company pioneering a new class of T cell engaging therapeutics, announced today that the first patient has been treated with HPN424 in a Phase 1 clinical study of metastatic castration-resistant prostate cancer (mCRPC) patients. HPN424 is the first of multiple compounds in development that are based on the company’s TriTAC (Tri-specific T cell Activating Construct) platform and designed to penetrate solid tumors, have extended serum half-life, and recruit patients’ own T cells to destroy malignant tumor cells. The Phase 1 trial is a multicenter, multinational, open-label, ascending dose study designed to evaluate the safety, tolerability and pharmacokinetics of HPN424 in approximately 40 patients with metastatic prostate cancer.

Press release available here: https://www.harpoontx.com/news/080618/

Verona Pharma Initiates Phase 2 Clinical Trial Evaluating Nebulized RPL554 as Add-on to Dual Bronchodilator Therapy for COPD Maintenance Treatment

LONDON, Aug. 01, 2018 -- Verona Pharma plc (AIM:VRP) (Nasdaq:VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces the initiation of a Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to treatment with dual long-acting anti-muscarinic / long-acting beta2-agonist drugs (“LAMA/LABA”), which are commonly used in the maintenance treatment of patients with moderate to severe chronic obstructive pulmonary disease (“COPD”). The first patients have been enrolled and dosed in the study, and top line data are expected in the first quarter of 2019.

Press release available here: http://investors.veronapharma.com/news-releases/news-release-details/verona-pharma-initiates-phase-2-clinical-trial-evaluating

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About Arix Bioscience plc

Arix Bioscience plc is a global healthcare and life science company supporting medical innovation. Headquartered in London and with an office in New York, Arix Bioscience sources, finances and builds world class healthcare and life science businesses addressing medical innovation at all stages of development. Operations are supported by privileged access to breakthrough academic science and strategic relationships with leading research accelerators and global pharmaceutical companies.

Arix Bioscience plc is listed on the Main Market of the London Stock Exchange. For further information, please visit www.arixbioscience.com

About Harpoon Therapeutics, Inc

Harpoon Therapeutics is a clinical-stage immuno-oncology company founded by Patrick Baeuerle, PhD, a pioneer in the development of T cell engaging therapies, and MPM Capital. The company is focused on the discovery and development of novel T cell engaging biologics for the treatment of cancer. Harpoon Therapeutics created a novel T cell redirection platform called TriTAC (Tri-specific T cell Activating Construct) to unleash the targeted cell-killing properties of a patient's own immune system through T cell activation. This approach has been optimized to overcome the limitations of existing immunotherapies to penetrate tissues and extend serum exposure for superior efficacy in solid tumors. Harpoon is developing a robust pipeline of TriTAC candidates. Harpoon has initiated a Phase 1 clinical trial for lead candidate HPN424, a prostate-specific membrane antigen (PSMA)-targeting TriTAC, and expects to file an investigational new drug application for HPN536, a mesothelin-targeting TriTAC soon. For more information, please visit www.harpoontx.com

About Iterum Therapeutics plc

Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated antibiotics aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem antibiotic compound with oral and IV formulations that has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. For more information, please visit http://www.iterumtx.com

About Verona Pharma plc

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. Verona Pharma's product candidate, RPL554, is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that acts as both a bronchodilator and an anti-inflammatory agent in a single compound. In clinical trials, treatment with RPL554 has been observed to result in statistically significant improvements in lung function as compared to placebo, and has shown clinically meaningful and statistically significant improvements in lung function when administered in addition to frequently used short- and long-acting bronchodilators as compared to such bronchodilators administered as a single agent. Verona Pharma is developing RPL554 for the treatment of chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and potentially asthma. http://www.veronapharma.com/