M. Scott Harris Email & Phone Number

Washington, Dc, Us

Gaithersburg, Maryland, Us

Altimmune is a clinical stage biopharmaceutical company focused on therapies in obesity, metabolic disease and liver disease. Our lead asset is pemvidutide, a next generation peptide therapeutic for obesity and NASH. The Company has grown rapidly, emerging into Phase 2 development and realizing a 20-fold or greater increase in market cap since the fall of 2019. In my first 3 years at Altimmune, I led the filing of 5 INDs, completion of 7 Phase 1 and 2 clinical trials and built clinical development and regulatory affairs into a high-performance team of over 35 team members. A highly successful Phase 2 trial in obesity (MOMENTUM) was recently completed, demonstrating class-leading effects on lipids, liver fat reduction and lean mass preservation, and the Company is moving towards a much anticipated readout in a Phase 2 biopsy-driven trial in NASH in the first quarter of 2025.

My consulting firm specializes in drug development in gastrointestinal diseases (gastroenterology). I have designed and executed pre-IND to Phase 3 clinical development programs in ulcerative colitis, Crohn’s disease, irritable bowel syndrome, gastroparesis, fecal microbiota transplantation and celiac disease. I have served on numerous scientific advisory boards and data monitoring committees and have represented companies in M&As, partnerships, and investment opportunities in the gastroenterology space.

I have held a position on the faculty of Georgetown University School of Medicine since 2006. While I previously maintained an academic medical practice in inflammatory bowel disease, my current role is teaching and administration. I am the director of a heavily-subscribed one-semester course in drug development in the Master's Program of the Georgetown-Howard University Center for Clinical and Translational Science (GHUCCTS).

Lyric was a clinical stage company developing novel gastrointestinal therapeutics for critical care gastrointestinal indications. The lead indication for Lyric's first program was the treatment of enteral feeding intolerance (EFI). The company in-licensed its initial development candidate in September 2014, closed a $20.8 million Series A financing in February 2015 and executed four Phase 1 and 2 clinical trials through June 2018.

Avaxia was a clinical-stage biotechnology company that was the leader in the growing field of gut-targeted therapeutics — orally administered, minimally absorbed drugs that are designed to act locally in the gastrointestinal GI) tract. Avaxia’s lead clinical candidate, AVX-470, was an oral anti-TNF antibody for inflammatory bowel disease, including ulcerative colitis and Crohn's disease. This transformative product offered improved safety and efficacy over existing anti-TNF therapies by focusing immune suppression only where needed in the diseased gut.

Ocera emerged as a public biotech company (NASDAQ: OCRX) in the IBD and liver disease therapeutic spaces until its acquisition by Mallinckrodt Laboratories in 2017. I led medical diligence for the in-licensing of OCR-002 (L-ornithine phenylacetate), an oral and intravenous ammonia-lowering agent for treatment of hepatic encephalopathy from University College London in 2008. I facilitated the merger of Ocera with Tranzyme Pharmaceuticals in 2013.

I was the author of the Phase 3 program that resulted in the approval of Mytesi® (crofelemer) in 2012 for HIV-associated diarrhea. The pivotal, registrational trial was the first adaptive trial methodology to be accepted by the FDA under Special Protocol Assessment (SPA) and the first to result in drug approval. The program was successfully partnered with Salix Pharmaceuticals in 2008. I also oversaw an international trial (ICDDR, Bangladesh) in cholera-associated diarrhea and consulted for the Bill and Melinda Gates Foundation in its international pediatric diarrhea program.

Md, Medicine

Ba, Chemistry

M.S., Administrative Medicine And Population Health