AVX 001 / Coegin Pharma - LARVOL DELTA

Mobile health technologies in an interventional hybrid study on actinic keratosis: Results from an early phase randomized controlled trial investigating the safety and efficacy of a cytosolic phospholipase A2 inhibitor gel in photodamaged skin. (PubMed, Exp Dermatol) - "At EOT, AVX001 achieved a subtle treatment response with clearance of AK target area of >50% in 18% of patients. Remote and in-clinic assessments of LSRs were in high agreement, suggesting that the use of mobile health technologies in early-phase hybrid studies of AK does not compromise patient safety."

Journal • Actinic Keratosis • Dermatology

The Copenhagen Actinic Keratosis Study (COAKS). A decentralised clinical trial to evaluate tolerability, safety and efficacy of daily field-directed topical treatment with cytosolic phospholipase A inhibitor, AVX001, in participants with actinic keratosis: protocol for a randomised controlled phase I/IIa trial. (PubMed, BMJ Open) - P1/2 | "Results will be submitted for publication in peer-reviewed scientific journals. 2021-000934-32; NCT05164393."

Journal • P1/2 data • Actinic Keratosis • Dermatology • Oncology

COAKS: Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: Coegin Pharma AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Actinic Keratosis • Dermatology

COAKS: Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: Coegin Pharma AB

Clinical • New P1/2 trial • Actinic Keratosis • Dermatology

Therapeutically relevant immunological changes observed following a phase 1 trialof PVX108 peptide-immunotherapy in peanut-allergic adults (EAACI 2021) - "We previously reported clear safety and tolerability of PVX108 in a phase I trial (AVX-001) in peanut allergic adults. These changes occurred without requirement for ongoing dosing and without inducing large IgE responses during treatment, as seen with whole allergen immunotherapy. These findings support the improved safety profile, proposed mechanism of action and progression of PVX108 into phase 2 clinical trials."

Clinical • IO biomarker • P1 data • Allergy • Food Hypersensitivity • Immunology • Inflammation • CD4 • CD40LG

cPLAα Enzyme Inhibition Attenuates Inflammation and Keratinocyte Proliferation. (PubMed, Biomolecules) - "We demonstrated that inhibition of cPLAα using AVX001 produced a balanced reduction of prostaglandins and leukotrienes; significantly limited prostaglandin E (PGE) release from both PBMC and HaCaT in response to pro-inflammatory stimuli; attenuated growth factor-induced arachidonic acid and PGE release from HaCaT; and inhibited keratinocyte proliferation in the absence and presence of exogenous growth factors, as well as in stratified cultures. These data suggest that the anti-psoriatic properties of AVX001 could result from a combination of anti-inflammatory and anti-proliferative effects, probably due to reduced local eicosanoid availability."

Journal • Dermatology • Immunology • Inflammation • Psoriasis

Avexxin: Corporate Factsheet (Avexxin) - Anticipated data from P1/2a trial in patients with mild to moderate psoriasis in Q2 2014

Anticipated P1/2 data • Psoriasis

Cytosolic group IVA phospholipase A2 inhibitors, AVX001 and AVX002, ameliorate collagen-induced arthritis. (PubMed, Arthritis Res Ther) - "AVX001 and AVX002 display potent anti-inflammatory activity and disease-modifying properties in cellular and in vivo models. The in vivo effects of AVX001 and AVX002 were comparable to, or superior, to those of MTX and Enbrel. Taken together, this study suggests that cPLA2α inhibitors AVX001 and AVX002 are promising small molecule disease-modifying anti-rheumatic therapies."

Biomarker • Journal