Aravax receives positive pre-IND feedback from FDA on PVX108 Phase 2 trial plans.

30 September 2019, Melbourne, AUSTRALIA: Aravax, a clinical stage biotechnology company

focused on developing the first therapy for peanut allergy which is designed to be safe, effective and

convenient, has received positive feedback from the U.S Food and Drug Administration (FDA) in regard

to its development plans for PVX108, a next generation, specific immunotherapy for the treatment of

peanut allergy.


PVX108 is a next-generation, allergen-specific immunotherapy using peptides that represent critical

fragments of peanut proteins to precisely target the T cells driving peanut allergy. Administered once

per month, therapy is designed to precisely induce tolerance to peanut protein without the safety

concerns constraining the use of the only registered therapy which uses natural extracts from

peanuts.


The pre-IND meeting filing enabled Aravax management to present the results of nonclinical and clinical

studies completed to date, its proposed Phase 2 clinical study design, and ask FDA questions about

the PVX108 clinical development program ahead of filing an Investigational New Drug (IND). IND

approval will enable Aravax to commence a Phase 2 clinical trials of PVX108 in the United States.


“We are extremely pleased with the feedback just received. FDA did not raise any concerns about the

nonclinical studies presented, our completed Phase 1 trial results, or our proposed Phase 2 design.

Furthermore, we received extremely useful advice about how to streamline our pharmaceutical

development activities moving forwards. This provides great confidence in progressing the IND

application and will send a positive signal to existing and incoming investors.” said Aravax CEO Pascal

Hickey.


Earlier this year, Aravax presented the results of its randomized, double-blind, placebo-controlled

Phase 1 trial(AVX-001) at the European Academy of Allergy and Clinical Immunology. The trial was

conducted in 66peanut-allergic adults at sites in Melbourne and Adelaide, Australia, and showed no

evidence that PVX108 was associated with acute reactions, and no adverse events of clinical concern

were observed. These data demonstrate that PVX108 has a highly favourable safety profile for

treatment of peanut allergic patients, including those with severe allergy.


Aravax now intends to complete further nonclinical studies and file its IND application to progress

Phase 2 trials in the U.S. and Australia.


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