The Interim data showed that 3 out of 9 evaluable patients on BBT-401 responded with more than 30% reduction in Total Mayo Score or 25% reduction in Partial Mayo Score
Safety and tolerability profiles remain consistent with results from Phase I trial in healthy volunteers
SEONGNAM, South Korea, April 9, 2020 /PRNewswire/ — Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, Republic of Korea, announced the interim data from the first cohort in the phase 2a study of BBT-401, an experimental drug for the treatment of ulcerative colitis (UC).
In the first cohort from the exploratory Phase 2a trial, 12 patients with active ulcerative colitis with Total Mayo Score of 5 or higher and Mayo Endoscopic Score of 1 or higher were randomized to and administered for 8 weeks with BBT-401 or placebo. Patients in treatment with second line therapies such as steroid injections, rectal suppositories or biologics were excluded from the enrollment.
Data analysis with 11 evaluable patients showed that 3 out of 9 evaluable patients on the experimental drug were respondents in Total Mayo Score or Partial Mayo Score, while none on placebo was a respondent.
In addition, data analysis confirmed that BBT-401 is well tolerable to the patients and most of the adverse events were mild with no case of serious adverse event (SAE). Only one possibly drug-related adverse event reported was mild flatulence. BBT-401 is confirmed to be gut-restricted without systemic exposure after oral administration, which is consistent with results from preclinical experiments and Phase I trial in healthy volunteers.
The company plans that the doses in the next cohorts will be escalated to further assess safety and efficacy profile at higher doses.
"With the data from the first dose group in the phase 2a study, our team is encouraged to advance the clinical trial to higher doses. We will continue working to deliver this novel compound to patients with active ulcerative colitis," stated James Lee, CEO of Bridge Biotherapeutics.
Sengho Jeon, CEO of Daewoong Pharmaceutical, the company which was sublicensed the right of BBT-401 in 22 Asian countries, commented: "Along with the interim results, Daewoong Pharmaceutical will further accelerate research and development of BBT-401, closely working in a collaboration with Bridge Biotherapeutics."
BBT-401, an experimental drug discovered by SKKU (Sungkyunkwan University) and KRICT (Korea Research Institute of Chemical Technology), is a GI-tract restricted small molecule Pellino-1 inhibitor. Bridge Biotherapeutics was licensed the worldwide exclusive right to the compound in 2015 and sublicensed the right in 22 Asian countries to Daewoong Pharmaceutical Co., Ltd. in 2018.
About Bridge Biotherapeutics
Bridge Biotherapeutics Inc. (KOSDAQ 288330), based in South Korea, US and China, is a publicly-traded clinical stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high-unmet needs, such as ulcerative colitis, fibrotic diseases, and cancers. BBT-401, the first-in-class Pellino-1 inhibitor for treatment of ulcerative colitis, is currently in Phase II in the US, and BBT-877, an autotaxin inhibitor to treat various fibrosing interstitial lung diseases including idiopathic pulmonary fibrosis (IPF), was licensed to Boehringer-Ingelheim for further development in July 2019 with potential license value more than 1.1 billion euro. BBT-176, a potent targeted cancer therapy for non–small cell lung cancer (NSCLC) is also in development. Bridge Biotherapeutics is a resident company of JLABS @ Shanghai.
About Pellino Proteins
Pellino proteins are a family of E3 ubiquitin ligases which are highly conserved across species in mammal. Pellinos also serve as scaffold proteins that bind to proteins in inflammatory signaling pathways, including IRAK4, MyD88 (myeloid differentiation primary response gene 88) and to RIPK1 in various physio-pathological conditions.
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