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NIA Small Business Showcase: Microbiotix, Inc.

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Microbiotix has a robust pipeline of target/receptor-based drug discovery and development programs targeting infectious diseases and meeting other unmet medical needs, including therapy for rheumatoid arthritis (RA). The company’s lead therapeutic compound, MBX-400 (filociclovir), is a potent and novel nucleoside analog for treating human cytomegalovirus (CMV) and has successfully completed Phase I clinical testing. MBX-400has also demonstrated broad activity against adenoviruses and is in preclinical development for adenoviral conjunctivitis, the most common form of conjunctivitis worldwide. The company’s rheumatoid arthritis program seeks to address how a unique receptor identified in RA patients binds to its complementary ligand and aggravates joint swelling and bone damage.

Two arches over the word "Microbiotix, Inc."Microbiotix is identifying compounds that can block the binding of this receptor to its natural ligand, thus abrogating inflammation and bone erosion and allowing development of novel therapies for RA that does not respond to current treatments.

Given that at least one-third of the 2.5 million rheumatoid arthritis patients in the United States are unresponsive to treatment or may become so, there is a continuing unmet need in this large and growing market, which experienced 4.6% growth from 2015 to 2018 and is expected to total $34 billion by 2025.

The novel RA mechanism will provide an important alternative therapy for patients unresponsive to current treatments. Coupled with a small molecule inhibitor that can be administered by mouth at lower cost and with longer stability than a biologic drug, this approach promises to alter the treatment regimen for RA.

Company Milestones

Scientific

The lead program (MBX-400 for CMV infections in transplant recipients) has successfully completed Phase I clinical trials, and the adenoviral conjunctivitis program is in preclinical development. In its rheumatoid arthritis program, the company is looking to identify a lead series of inhibitors in 2021.

Description

Date

MBX-400 for CMV infections in transplant recipients — Phase I clinical studies

Completed

MBX-400 for adenoviral conjunctivitis — submit an investigational new drug (IND) application

Q1 2021

Rheumatoid arthritis program — identify a small molecule lead series

2021

Business

Description

Date

CARB-X funding for T3SS inhibitors targeting Pseudomonas aeruginosa pneumonia

03/2017

CARB-X funding for a novel oral antibiotic to treat multidrug-resistant gonorrhea

03/2020

Financial Overview

Funding

Amount

$2 million pharmaceutical equity investment

$2 million

CARB-X (2017): for P. aeruginosa type III secretion inhibitors in pneumonia patients

Up to $3.2 million

CARB-X (2020): for a novel oral antibiotic to treat multidrug-resistant gonorrhea

Up to $2.86 million

NIH (National Institute of Allergy and Infectious Diseases, NIA), Department of Defense

Various

It will take $2 million to $3 million to finalize preclinical development and get through Phase I clinical trials for the adenoviral conjunctivitis program.

Intellectual Property

Microbiotix has more than two dozen issued patents covering five ongoing research and development programs, along with multiple patent applications. The company aggressively protects its intellectual property and pursues patent protection whenever appropriate. Its programs are covered by comprehensive composition-of-matter and use patents and pending patent applications worldwide. Microbiotix is actively developing its pipeline of next-generation medicinal products.

Product Development and Regulatory Strategy

Microbiotix’s research programs rely on internal innovation and university partnerships. The company has completed Phase I clinical trials in its MBX-400 CMV program, is in preclinical development in its MBX-400 adenoviral conjunctivitis program, and also has a tuberculosis program in preclinical development. The company’s development/regulatory strategy for its RA and other programs is to advance through IND and Phase I and into Phase II proof-of-concept studies before finding partners for late-stage clinical development and commercialization.

Commercialization Strategy

In the postclinical proof-of-concept stage, the company will seek a corporate partnership for late-stage studies, new drug application submissions, and commercialization.

Company Details

Microbiotix, Inc. website

One Innovation Drive
Worcester, MA 01605

Industry: Pharmaceutical

Management Team:

  • President and Chief Executive Officer: Terry L. Bowlin, Ph.D.
  • Chief Scientific Officer: Donald T. Moir, Ph.D.
  • Chief Business Officer: Richard Gauthier, M.B.A.

Point of Contact:
Terry L. Bowlin, Ph.D.
Email Terry L. Bowlin
(508) 757-2800

Conference Selected for Showcase: BIO Digital (June 2020)