Camallergy Provides Corporate Update and Prepares to Advance Lead Candidate CA002 Into Phase 3 Efficacy Trial for Peanut Allergy

-Phase 3 development program aligned with FDA feedback, supporting development path to BLA

-Pivotal Phase 3 clinical efficacy trial planned for mid-2020

-Barry Saint joins Camallergy as Chief Financial Officer

-Camallergy to attend upcoming Jefferies London Healthcare conference on 20-21 November

CAMBRIDGE, England--()--Cambridge Allergy Ltd (“Camallergy” or “the Company”), a biopharmaceutical company dedicated to providing innovative, patient-centric treatments for life-threatening food allergies, today provided a corporate update, including recent progress with its development of CA002 for the treatment of peanut allergy.

CA002 is a novel and proprietary formulation of whole peanut protein specifically designed to enable the safe and tolerable oral administration of whole peanut protein as an oral immunotherapy to treat peanut allergy with a formulation and treatment regimen optimized to provide a safe and tolerable treatment for peanut allergy with class leading efficacy.

Camallergy’s scientific founders recently presented data at EAACI in Lisbon and BSACI in London demonstrating the highly differentiated safety and tolerability profile associated with the proprietary treatment regimen underlying the foundation of Camallergy. As reported at EAACI, the safety and tolerability profile was characterized by well tolerated Initial Day of Therapy, with a cumulative 94% of treatment days symptom free. Additionally, data from the STOP 2 Phase 2 trial and data from the Cambridge Peanut Allergy Clinic demonstrate an overall high tolerability and compliance with only 13% and 4%, respectively, of patients withdrawing during treatment. Importantly, subjects are experiencing less than half the utilization of epinephrine injections compared to other oral immunotherapies. Camallergy plans to present additional results from its partner, the Cambridge Peanut Allergy Clinic, at upcoming medical meetings.

Dr. Andrew Clark, co-founder and Chief Medical Officer of Camallergy, commented, “We are excited that we continue to see such favourable comparison of our proprietary treatment regimen in our commercial clinic at Cambridge University Hospitals as compared to other reported oral immunotherapies. The drug profile we are seeing is well suited to the treatment of peanut allergy and, by thoughtful design, predicts to be the most patient friendly oral immunotherapy to treat the millions of children with peanut allergy.”

Camallergy also announced the successful completion of guidance with the U.S. Food and Drug Administration (FDA) which parallels guidance received from the European Medicinal Agency (EMA). In these consultations, the Company has established key elements of the Phase 3 development program to support a Biologics License Application for CA002 for the treatment of peanut allergy.

Camallergy plans to initiate a randomized, double-blind, placebo-controlled Phase 3 clinical trial by mid-year 2020 to evaluate the efficacy and safety of CA002 as a treatment for peanut allergy.

As the Company embarks on its pathway towards global growth, Camallergy has recently appointed Barry Saint as its Chief Financial Officer. Mr. Saint joins Camallergy from Indivior where he served as Global Head of Corporate Finance and Group Treasurer for the international pharmaceutical group. Prior to joining Indivior, Barry served as a senior investment banker advising clients during pivotal growth objectives including IPO’s, M&A activity and financings.

Baxter Phillips III, Chief Executive Officer of Camallergy commented, “Barry brings to Camallergy substantial leadership in relevant finance and strategic planning within the pharmaceutical industry, including successful management of international public offerings as well as private equity transactions. His leadership and financial acumen will greatly benefit the Company as we continue to grow and plan for our major pivotal studies next year.”

Camallergy will be attending Jefferies 2019 Healthcare Investor Conference in London on 20-21 November, where the Company will be available for one-on-one meetings. To schedule a meeting, please contact your conference representative or the Company directly at investors@camallergy.com.

About Camallergy

Camallergy (Cambridge Allergy Ltd) is a biopharmaceutical company dedicated to providing innovative, patient-centric treatments to address the millions of patients suffering worldwide from food allergies. Camallergy’s lead product, CA002, is a novel oral immunotherapy for the treatment of peanut allergies designed to offer “bite-proof” protection to patients within 14 weeks of therapy. The company’s unique intellectual property and treatment algorithm is based on the clinical work initiated at Cambridge University Hospitals NHS Foundation Trust in Cambridge, U.K., by the scientific co-founders of the company, Dr. Andrew Clark and Dr. Pamela Ewan. Camallergy has its headquarters in Cambridge, UK, with key functions and members of its leadership team located in the United States. www.camallergy.com.

About Cambridge Peanut Allergy Clinic

Cambridge Peanut Allergy Clinic is a private, pediatric clinic run by the Cambridge University Hospitals NHS Foundation Trust and is directed by Drs. Pamela Ewan and Andrew Clark, who are world-renowned specialists in the fields of allergy and immunotherapy. The clinic offers immunotherapy among a range of services. www.peanut.cuh.org.uk.

Contacts

Barry Saint, Chief Financial Officer
barry.saint@camallergy.com

Baxter Phillips III, Chief Executive Officer
baxter@camallergy.com

Release Summary

Camallergy Prepares to Advance Lead Oral Immunotherapy Drug Candidate, CA002, Into Phase 3 Efficacy Trial for Peanut Allergy.

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Contacts

Barry Saint, Chief Financial Officer
barry.saint@camallergy.com

Baxter Phillips III, Chief Executive Officer
baxter@camallergy.com