Enthera Pharmaceuticals appoints Lisa M. Olson as CEO and announces clinical trial progress with Ent001

• Industry veteran Dr. Olson moves from Enthera’s Board to take the helm as CEO
• Ent001 Phase 1a trial in healthy volunteers completed with positive topline safety results
• Company has initiated enrollment for Ent001 Phase 1b trial in patients with moderately to severely active ulcerative colitis

MILAN--(BUSINESS WIRE) - Enthera Pharmaceuticals (“Enthera”), a clinical-stage biotech company developing first-in-class antibody therapeutics targeting the Insulin Growth Factor Binding Protein (IGFBP) family for selected inflammatory diseases, today announced the appointment of Lisa M. Olson, PhD, as the company’s Chief Executive Officer. Dr. Olson joins Enthera’s management team with over two decades of leadership experience in the biopharmaceutical industry including a successful career at AbbVie. She previously served as a member of Enthera’s Board of Directors and Chair of the Scientific Advisory Board.

Enthera also announced completion of Ent001’s Phase 1a single-ascending dose trial in healthy volunteers, establishing a positive safety and tolerability profile and enabling the start of the Phase 1b multiple ascending dose trial in ulcerative colitis (UC) patients. UC is a chronic gastrointestinal disease, and while treatment options using immune suppressors are efficacious, they still fail to provide a durable and long-term response for many patients with moderately to severely active disease. Ent001 is a monoclonal antibody targeting the IGFBP3/TMEM219 pathway, which plays a critical role in gut mucosal integrity and is dysregulated in patients with inflammatory bowel diseases (IBD), including UC.

“We are entering the new year with positive momentum in Enthera’s corporate and clinical evolution with Lisa’s appointment as CEO and important progress with Ent001. The Enthera team will benefit from Lisa’s scientific and R&D expertise and leadership experience cultivated across the pharmaceutical and biotechnology industries. We are thrilled to have her join as CEO,” said Silvano Spinelli, Chairman of the Enthera Board of Directors.

“I look forward to working with the Enthera team to further drive Ent001’s clinical development trajectory. We have defined an exciting opportunity with Ent001 for the long-term treatment of ulcerative colitis, a disease that continues to negatively impact the lives of many patients,” added Dr. Lisa M. Olson, CEO of Enthera. “My goal is to ensure we deliver on the potential of Ent001 in the clinic and to achieve our ambitious corporate objectives for 2024.”

Ent001 Clinical Development Updates

Enthera completed its single ascending dose (SAD) Phase 1a trial evaluating Ent001 in healthy volunteers, thereby laying the groundwork for evaluation in patients with IBD and other indications, including type 1 diabetes (T1D), where the IGFBP3/TMEM219 pathway also plays a key pathogenetic role. The Phase 1a trial was conducted in the Netherlands and involved 30 healthy volunteers who received single ascending doses of Ent001 or placebo administered by intravenous infusion. The trial results established a very positive safety and tolerability profile for Ent001 without any observations of drug-related clinically relevant adverse reactions up to the highest dose tested (10mg/kg). The pharmacokinetics (PK) were linear, and the exposures reached in this study fully cover the concentrations that are predicted to be effective in patients, based on the maximum effective dose in animal disease models of UC.

Based on this, Enthera has initiated a multiple ascending dose (MAD) Phase 1b clinical trial in patients with moderately to severely active UC.

The Phase 1b multicenter, randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability, immunogenicity and PK of multiple ascending doses of Ent001 in up to 40 patients with moderately to severely active UC. The trial will also analyze pharmacodynamic responses by measuring peripheral and colon tissue biomarkers of IGFBP3/TMEM219 pathway inhibition to demonstrate proof of mechanism in patients with active colitis. Patients will be dosed up to week 12 to collect exploratory efficacy data and evidence of the compelling mucosal healing effect observed in preclinical models of colitis.

About Dr. Lisa M. Olson, CEO of Enthera

Prior to joining Enthera, Dr. Olson most recently served as the Chief Scientific Officer of Magenta Therapeutics where she was responsible for the strategic direction and execution of the company’s research and development efforts. Before this, Dr. Olson held various leadership positions at AbbVie and Abbott Laboratories for fifteen years, culminating in her role as Vice President Immunology Discovery and Site Head of the AbbVie Bioresearch Center. During her time at AbbVie she successfully advanced 15 molecules into clinical development including Rinvoq™ (upadacitinib) for the treatment of several conditions, including UC. Dr. Olson joined Abbott following her time as a Research Fellow in Inflammation and Immunology at Pfizer, Inc. Dr. Olson started her career as an Assistant Professor at Washington University School of Medicine following a post-doctoral cardiovascular fellowship at the University of Chicago. She holds a Ph.D. from the University of Illinois at Urbana-Champaign and a B.S. from Iowa State University.

About Enthera Pharmaceuticals

Enthera Srl is a clinical-stage biotech company developing first-in-class antibody therapeutics to transform the treatment paradigm in inflammatory bowel diseases (IBD) and type 1 diabetes (T1D) by re-establishing stem cell capabilities. Enthera’s pioneering approach capitalizes on the key discovery of the IGFBP3/TMEM219 pathway, which is involved in stem cell and beta cell apoptosis in the gut and pancreas, respectively. Enthera’s lead program, Ent001, which is currently in Phase 1 clinical development, has the potential to restore the original intestinal mucosal structure in IBD and the endogenous pancreatic stem cell compartment in T1D, resulting in the restoration of organ function.

Enthera is a private company headquartered in Milan, Italy and founded in 2016 by Prof. Paolo Fiorina and Dr. Francesca D’Addio with BiovelocITA, Italy’s first biotech accelerator. Enthera’s discovery engine and assets are protected by a broad portfolio of patents. The company is backed by Sofinnova Partners, AbbVie, JDRF T1D Fund, Roche Venture Fund, and several private investors.

For further information: www.entherapharmaceuticals.com (https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.entherapharmaceuticals.com&esheet=53885901&newsitemid=20240123274068&lan=en-US&anchor=www.entherapharmaceuticals.com&index=3&md5=2d1d345ecad55ba26a60614177fe6961)

Contacts

Enthera Pharmaceuticals
Lisa M. Olson Ph.D., CEO
info@entherapharmaceuticals.com

Trophic Communications
Valeria Fisher or Veronika Máté
+49 175 8041816 or +49 160 90816161
enthera@trophic.eu