SkinBio Therapeutics Provided a Business Update on 8/16/18
Using a third party manufacturer, the company has now achieved significant manufacturing scale up with, with no detrimental impact upon the active properties of the SkinBiotix technology.
Additionally the material, which to date has been manufactured and supplied in a liquid form, has now been successfully freeze dried. The ability to freeze dry the material is an important steps towards commercialisation as it enables mass production, storage and transportation.
The SkinBiotix technology has been shown to be stable and effective within the cream formulation for 24 hours. The human study, which is due to commence in September, is subject to the Company's ongoing work to confirm stability of the current formulation over an extended timeframe. The Company expects to provide an update on this in the coming weeks.
Synlogic Publishes Preclinical Data Supporting Development of SYNB1618, a Synthetic Biotic Medicine as a Potential Treatment for Phenylketonuria
Synlogic, Inc., (Nasdaq: SYBX) a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, today announced the publication of data from preclinical studies of SYNB1618, the Company’s Synthetic Biotic development program targeting PKU, in Nature Biotechnology.The data demonstrate that oral administration of SYNB1618 significantly reduced blood phenylalanine (Phe) levels, the key metabolite associated with PKU, in mouse models of PKU and resulted in dose-dependent pharmacodynamics in healthy non-human primates (NHPs).
The paper titled “Development of a synthetic live bacterial therapeutic for the human metabolic disease phenylketonuria” appears as an Advance Online Publication on Nature Biotechnology’s website.
“These preclinical studies highlight the potential of our engineered Synthetic Biotic medicines to act with potency within the gut to normalize systemic levels of a toxic metabolite. In addition, in two species, we demonstrate dose-dependent production of biomarkers of activity for SYNB1618, which will be very useful in evaluating its efficacy in our ongoing clinical study in healthy volunteers and patients with PKU,” said Paul Miller, Ph.D., Synlogic’s chief scientific officer. “These data provide compelling evidence to support the continued development of our orally administered Synthetic Biotic medicine, SYNB1618, for the potential treatment of PKU.”
To monitor SYNB1618 activity in vivo, Synlogic scientists investigated the production of major SYNB1618-derived metabolites, including TCA and HA. Studies demonstrated that orally administered SYNB1618 resulted in a significant decrease in blood Phe levels independent of dietary protein intake in the PKU mouse model, and inhibited increases in serum Phe after an oral Phe challenge in healthy NHPs. In both species, SYNB1618 exhibited dose-responsive pharmacokinetics, as determined by production of urinary HA.
Synlogic is currently evaluating SYNB1618 in a Phase 1/2a clinical trial for the management of PKU and expects to report interim data from healthy volunteers in 2018 and full data, including cohorts of patients with PKU, in 2019. More information about Synlogic’s Phase 1/2a clinical trial in healthy adult volunteers and patients with PKU can be found at https://clinicaltrials.gov under the study ID NCT03516487.
FDA Commissioner Issued a Statement on Advancing the Science and Regulation of Live Microbiome-Based Products
In the statement, FDA Commissioner, Scott Gottlieb, MD, acknowledged the public interest in live microorganisms and their role in health maintenance and disease prevention. He also referenced a guidance document issued in 2016 that explains how researchers studying probiotics as drugs can meet the manufacturing requirements necessary for early clinical trials.
“More work and continued partnership between the FDA and various stakeholders is needed to advance the clinical science necessary to appropriately understand the safety and effectiveness of these products. We are committed to these goals,” he said.
It was also announced in the statement that the FDA is convening a workshop on September 17 to, “discuss microbiome-based products and how manipulation of the microbiome may potentially be used to prevent or treat a variety of different diseases. Presentations will be given on a variety of topics including: the regulatory framework for live microbiome-based products; safety and effectiveness of live microbiome-based products used to prevent, treat, or cure diseases in humans; and strain selection for live microbiome-based products to prevent, treat, or cure diseases in humans.”
