An Israeli biotech with a Branford location reported disappointing results in a Phase 2 cosmetic trial for a topical gel that uses a cocktail of naturally occurring organisms to destroy acne-causing bacteria on the skin.
BiomX said the good news was the study found its anti-acne gel BX001 was safe and well-tolerated and produced a statistically significant improvement in the appearance of acne-prone skin.
However, there was no meaningful difference in efficacy compared to patients who were given a version of the gel without the active ingredient, as a placebo. The company said it is evaluating the data before deciding on the future of the program.
The active ingredient in the gel is a cocktail of phages, which are viruses that target and destroy harmful bacteria without killing the potentially good bacteria around it.
BiomX’s 12-week trial enrolled 140 women with mild-to-moderate acne who applied either BX001 or the placebo twice a day. Both groups experienced a similar reduction in inflammatory and non-inflammatory acne lesions, the company said.
“Compared to our prior Phase 1 trial, this study enrolled significantly more subjects and tested BX001 over a longer application period, so we were pleased to see that BX001 maintained an excellent safety and tolerability profile,” CEO Jonathan Solomon said in a statement. “However, we were disappointed that BX001 did not demonstrate a meaningful differentiation from [placebo] on efficacy.”
Even so, the company said patients enrolled in the study indicated “preference for BX001 over [the inactive version] in key parameters.” Eighty percent reported “reduction in skin redness and tenderness of skin bumps” and said the product “left skin hydrated and noticeably improved the feel of their skin.”
BiomX is one of a wave of new companies focused on the microbiome, the community of microorganisms that live in the body and on the skin.
The company is headquartered in Ness Ziona, Israel and just opened a Branford location at 36 E. Industrial Road in September, where its chief medical officer, Sailaja Puttagunta, and her clinical team are based.
Last week, the company announced a $3 million equity investment from Japanese dermatology-focused pharmaceutical firm Maruho Co. Ltd. for the first right to license BiomX atopic dermatitis treatment BX005 in Japan. That product is in Phase 12 human testing with results expected in 2022.
The company is also working on phage therapy treatments for inflammatory bowel disease, cystic fibrosis and colorectal cancer.
Contact Natalie Missakian at news@newhavenbiz.com
