Suono Bio Inc., the company revolutionizing therapeutic platforms to improve the efficacy and safety of novel medicines, has released encouraging results from the first in human clinical trial testing its SuonoCalm™ platform. This is the first clinical demonstration of the feasibility and safety of applying ultrasound in the gastrointestinal tract for the purpose of delivering drugs.
“We now know, and can take these data to inform our final product designs for our planned IND for treatment of ulcerative colitis with a mesalamine product.”‘
“These data are compelling for our ultrasonic platform, demonstrating that ultrasound can be locally applied in the GI tract to deliver a drug, ultra-rapidly, in a safe and tolerable manner to a patient. This sets the stage for not only this clinical program, but our additional programs, including ingestible pill formats for oral delivery of biologics including nucleic acid-based medicines,” said Scott Kellogg, CEO of Suono Bio.
SuonoCalm is a therapeutic platform for the ultra-rapid administration of a wide range of medicines, including gene therapies. This lead program is intended for the treatment of ulcerative colitis and represents Suono Bio’s lead indication, addressing a significant unmet need. The core technology is also being applied in ingestible pill formats. Suono Bio’s strategy to accelerate approval and commercialization of powered delivery of drugs with diseases such as ulcerative colitis, and type 2 diabetes, where unmet need is well-documented and potential for near-term patient impacts and health system cost reduction is greatest.
“While ultrasonic energy has been used transdermally and in other medical devices, the unknown was whether patients could tolerate ultrasonic energy in the GI tract,” said Morgan Brophy, Manager of Clinical and Regulatory Affairs of Suono Bio. “We now know, and can take these data to inform our final product designs for our planned IND for treatment of ulcerative colitis with a mesalamine product.”
First in Human Study Summary
Suono Bio’s open-label, single-dose study in healthy volunteers is evaluating the safety and tolerability of the delivery of ultrasonic energy with a 4g/60ml mesalamine rectal suspension. Preliminary analysis demonstrates that the primary endpoints were met. An assessment of gross and histological examination of tissue, blood analysis, and surveys from subjects and clinicians support the safety and tolerability of the product, with no serious adverse events. This study will guide commercial product development and subsequent phase trials.
“Clinical demonstration of ultrasound tolerability represents a promising and critical step towards revolutionizing GI treatments. This major milestone not only propels the current SuonoCalm program but also validates the ultrasonic platform including the pill form factor,” said Giovanni Traverso M.D., PhD co-founder of Suono Bio.
About Suono Bio
Suono Bio is a clinical-stage company developing novel treatment options to enable the topical and oral delivery of biologics and genetic medicines in a formulation-independent manner. Suono Bio’s platform was developed at The Massachusetts Institute of Technology in Professor Robert Langer’s laboratory and enables rapid, delivery of a wide range of therapeutic payloads. For more information, please visit www.suonobio.com.
