Microbiome Report for Week Ending 3/9/19

March 15, 2019

Synlogic Achieves Milestone in Development of Synthetic Biotic for IBD
Synlogic, Inc (Nasdaq: SYBX) a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, announced on 3/6/19 the advancement of Synthetic Biotic medicines to the lead optimization stage in its collaboration with AbbVie, a global biopharmaceutical company, to develop an oral treatment for inflammatory bowel disease (IBD).

“We are delighted with the progress of our collaboration with AbbVie, a world-class company with expertise in immunology and the development of treatments for patients with inflammatory bowel disease,” said Aoife Brennan, M.B, Ch.B., Synlogic’s president and chief executive officer “Our collaboration has enabled us to broaden the reach of our platform in inflammatory and autoimmune conditions while advancing our internal pipeline in rare metabolic diseases.”

The company currently has five candidates in development, including an oncology program.

AOBiome Doses First Patient in Phase 1b Clinical Trial of B244 for the Treatment of Pediatric Atopic Dermatitis
AOBiome Therapeutics, Inc. (“AOBiome”) announced on 3/6/19 the administering of its lead product candidate, B244, to the first patient in the Company’s Phase 1b clinical trial to treat pediatric patients with atopic dermatitis (eczema).


The clinical trial is an open-label, multicenter, Phase 1b study of B244, a first-in-class, topical formulation of beneficial ammonia oxidizing bacteria (“AOB”), delivered as a topical spray twice daily and is designed to assess safety and tolerability in 36 pediatric patients aged 2 to 17 years with mild to moderate atopic dermatitis over a 28-day period.


“There is a significant medical need for new therapies to treat children with atopic dermatitis due to the high and increasing incidence of the disease and the limited number of safe and efficacious options to treat this sensitive population,” said President & CEO, Todd Krueger. “We look forward to announcing results from this study in the second half of 2019.”


In the United States, 13% of children (or 9.6 million) under the age of 18 years suffer from eczema.1 Of these, approximately one third have moderate to severe eczema. Additionally, many children who suffer from atopic dermatitis in their youth also go on to disproportionally suffer from certain diseases later in life, including 43% of children with severe atopic dermatitis before the age of 8 developing asthma and 45% developing allergic rhinitis according to one recent study.


“Our goal is to alleviate both the symptoms that are associated with atopic dermatitis and to utilize AOB’s nitric oxide-mediated anti-inflammatory abilities coupled with its capability to reduce levels of pathogenic bacteria as a dual-modality approach to treatment,” said Chief Medical Officer, Dr. Judith Ng Cashin, M.D. “Current therapies for atopic dermatitis can cause side effects such as stinging, burning, and thinning of skin, especially in pediatric patients. B244’s innovative nature represents a novel therapeutic opportunity to address the significant market need and to impact the lives of patients.”


In addition to the ongoing pediatric study, AOBiome is currently conducting a Phase 2 clinical trial investigating B244 for the treatment of adult atopic dermatitis with expected top-line data readout in 2019.


Infant Bacterial Therapeutics AB Announces Distribution Agreement For Israeli Market
Infant Bacterial Therapeutics AB announced on 3/5/19 the first distribution agreement for IBP-9414 with Megapharm Ltd. for the Israeli market and the Palestinian Authority’s territories. The agreement gives MegaPharm exclusive rights to market and sell the product, if and when the product receives market approval, after the pivotal clinical phase III trial that is expected to start during the current half year. MegaPharm will handle the registration, price negotiations as well as manage marketing and all of the practicalities that distribution of a pharmaceutical entails.

IBT is developing drug candidate IBP-9414 to prevent necrotizing enterocolitis (NEC), a devastating and often fatal disease in premature infants. IBP-9414 contains the active substance Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. IBT has an additional project in its portfolio, a second rare disease program, IBP-1016, for the treatment of an unmet medical need in gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.

IBT has chosen to establish a distribution agreement, and not a license agreement with significant up-front payments, in order to obtain a larger share of future sales revenue. IBT’s share will, after an initial shorter period, account for 70% of revenues.
 
As the Israeli health service offers advanced medical care for premature babies, IBT plans to open clinical trial centers for the pivotal phase III trial in the country. Megapharm is already participating in this work as it is essential to engage “key opinion leaders” in the marketing of the product.


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