FDA accepts Camallergy's phase 3 IND for "CA002" novel treatment for peanut allergy

- Regulatory approval to proceed with first clinical trial of our novel treatment for peanut allergy in the USA

- Clinical trial will be our first multi-centered and first placebo-controlled trial

CAMBRIDGE, UK – 1 July 2022 – Camallergy today announced that the US Food and Drug Administration (FDA) has accepted our Investigational New Drug (IND) application to proceed with phase 3 clinical trials of CA002 in the USA.

Peanut allergy is one of the most common food allergies, affecting millions worldwide and causing serious, potentially life-threatening reactions. CA002 is designed as a cutting-edge therapeutic approach, aiming to provide long-lasting protection against the dangers of accidental exposure.

"Our team is thrilled with the FDA's decision to accept our IND for Phase 3 trials. This marks a key milestone in the development of CA002 and brings hope to the peanut allergy community," said Mr Sherden Timmins, Co-founder and CEO. "The positive data from our phase 2 study and early access programme at the Cambridge Peanut Allergy Clinic demonstrate the potential of CA002 to safely and effectively desensitise individuals with peanut allergy and have consistently shown life-changing effects."

The phase 3 clinical trial program will evaluate the efficacy and safety of CA002 in a larger population of patients with peanut allergy, building on the promising results observed in previous clinical trials and the early access programme at the Cambridge Peanut Allergy Clinic. The placebo-controlled trials will recruit peanut-allergic children aged 4-17 years of age from the US and Europe. Camallergy is committed to addressing the urgent need for a safe, effective, and low-burden treatment option for those living with this challenging condition.

For updates about CA002 and our upcoming clinical trials, please register your interest at www.camallergy.com/contact.

About Camallergy

Camallergy (Cambridge Allergy Ltd) is a biopharmaceutical company spun out from Cambridge University Hospitals NHS Foundation Trust in Cambridge, UK. The company develops innovative, patient-centric treatments based on oral immunotherapy to address the tens of millions of patients worldwide living with food allergies. Oral immunotherapy is the only treatment approach for food allergy with evidence of safety and efficacy established through academic and commercial trials.

Disclaimer

This announcement may contain forward-looking statements about Camallergy's current expectations regarding future events, including the development and potential commercialisation of Camallergy's product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected.