– ‘1104 was safe and well-tolerated without serious adverse events –
NEW ORLEANS, LA and LONDON UK, May 4, 2021 – Revolo Biotherapeutics (“Revolo Bio” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission in patients with autoimmune (‘1805 a protein drug) and allergic disease (‘1104 a peptide drug), announced today positive data from a multiple ascending dose (MAD) Phase 1 clinical trial evaluating the safety and tolerability of ‘1104, a first-in-class peptide for the treatment of allergic disease. The data demonstrated that ‘1104 was safe and well-tolerated at the two doses evaluated (4 and 8 mg) without serious adverse events.
“These data, together with the previous positive safety data seen in a Phase 1 clinical trial of ‘1104 in 94 healthy volunteers and people with mild asthma, support the thesis that ‘1104 is a safe and tolerable treatment option for people with allergic disease,” said Jeff Myers M.D. Ph.D., Chief Medical Officer of Revolo Bio. “In totality, the findings support continued advancement and further evaluation of ‘1104 in our upcoming Phase 2 clinical trials.”
Jonathan Rigby, Chief Executive Officer of Revolo Bio, added, “Despite decades of research, people with allergic diseases are still in need of treatments that provide long-term disease remission and avoid immunosuppression. In multiple preclinical studies, ‘1104 effectively reduced the number of key cells involved in allergic inflammation. The encouraging safety data support our plan to evaluate ‘1104 in two upcoming Phase 2 clinical trials in eosinophilic esophagitis and allergen sensitivity.”
The Phase 1 randomized, double-blind, placebo-controlled clinical trial (NCT04748536) was designed to evaluate the safety and tolerability of multiple doses of ‘1104 in healthy volunteers. The study enrolled 18 subjects in two cohorts. The first cohort (n=8) received 4 mg of ‘1104 (n=6) intravenously or placebo (n=2) once daily for five days. The second cohort (n=10) received 8 mg of ‘1104 (n=8) intravenously or placebo (n=2) once daily for seven days.
‘1104 is a first-in-class peptide derived from a natural immune-regulatory protein, mTB Chaperonin 60.1 that is involved in resetting the immune system. Revolo Bio is advancing ‘1104 through two Phase 2 trials: one in patients with eosinophilic esophagitis (EoE) and one is patients with allergen sensitivity, while exploring its potential for other allergic diseases.
About Revolo Biotherapeutics
Revolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic disease, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, reset the immune system by preventing the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. ‘1805 is a modified analogue of a key protein in immune function and is entering clinical development for its second Phase 2 trial in moderate-to-severe rheumatoid arthritis and a Phase 2 clinical trial in non-infectious uveitis. ‘1104 is a peptide derived from a natural immune-regulatory protein and is entering Phase 2 clinical development for patients with eosinophilic esophagitis (EoE) and allergic disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases.
For further information, please visit www.revolobio.com.
Marylyn Rigby, VP Investor Relations & Marketing
Monica Rouco Molina, Ph.D.