Relief TherapeuticsSupporting patients through science and innovation
Aviptadil for sarcoidosis
Following a phase II trial in 20 sarcoidosis patients demonstrating a striking suppression of inflammatory mechanisms of the lung, in combination with amelioration of dry cough and of exertional dyspnea, Relief intends to engage into a phase III clinical trial campaign named Avisarco III.
The clinical trial design is based on the previous data obtained during the phase II study, where aviptadil inhalation demonstrated a very good efficacy on dry cough and dyspnea with a very good safety outcome. Furthermore, mechanistically it was found that aviptadil significantly restores immune tolerance by promoting regulatory T-lymphocytes and dampens inflammatory mechanisms in the lungs. Aviptadil is the only known experimental drug that could potentially suppress sarcoidosis-associated cough with almost no side effects.
The phase III study will be a multicentric, placebo controlled, double blind, randomized clinical trial involving 200 sarcoidosis patients indicated for active treatment. The treatment duration will be for 24 weeks for each patient.
The beginning of the clinical trial (first patient enrolled) is forecasted for late 2016, final report on the trial is expected for Q3 2019 and market authorization projected for Q1 2020.
Relief intends to engage into a phase II clinical trial campaign with the aim to rapidly generate relevant data to drive decision on late stage development. Phase II will start with a focused, cost-contained trial assessing objective and quantifiable end points following limited treatment duration. The trial is entitled “ATEXADIANE” for ATEXakin Alfa in DIAbetic NEuropathies. This trial will involve type 2 diabetic patients with mild to moderate Distal Symmetrical Polyneuropathy (DSPN) with a randomized, placebo-controlled, double blind design testing safety and efficacy at both the physiological and clinical aspects of two doses of atexakin alfa.
Based on previous clinical investigations as a thrombopoietic factor in different clinical settings, and treating more than 700 patients, the maximum tolerated dose (MTD) is already established. The selected doses for the diabetic neuropathy clinical trials are considered safe as it is up to 50 times lower than MTD. In addition, the clinical-grade batch of atexakin alfa that has been approved by the Medicines & Healthcare products Regulatory Agency of the United Kingdom in the year 2004 for use in clinical trials is readily usable for the upcoming diabetic neuropathy trial.
The beginning of the clinical trial (first patient enrolled) is forecasted during the first half of 2017, final report on the trial is expected for the first half of 2018. Following this phase II and depending on data quality, Relief might decide to continue the development on its own or search for co-development partners for phase III studies and marketing. Atexakin alfa is expected to be launched in 2021.