Enteris BioPharma Presents Study of Ovarest® Demonstrating Oral Delivery Comparable to or Exceeding Injectable Leuprolide

Oral Presentation Delivered at the American Society for Reproductive Medicine Scientific (ASRM) 2022 Congress & Expo

Boonton, NJOctober 26, 2022  — Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH), announced today that research into the pharmacokinetics of an oral formulation of leuprolide (Ovarest®) utilizing Enteris’ proprietary Peptelligence® platform was highlighted in an oral presentation at the ASRM 2022 Scientific Congress & Expo in Anaheim, Calif.

The American Society for Reproductive Medicine’s conference in Anaheim, Calif., features experts in reproductive endocrinology and infertility, genetics, male reproduction, and includes presentations on current basic and clinical research, access to care and practice management among other topics. Enteris Chief Medical Officer Dr. Gary Shangold, who was lead author of the study titled “Pharmacokinetic (PK) Study of Oral Leuprolide Delivery with Ovarest® Achieves Drug Levels Exceeding those of Approved Injectable Formulations,” gave the presentation today.

Peptelligence is a novel formulation technology designed to enhance the oral delivery and bioavailability of selected drugs by enhancing the permeation of such compounds that are typically injected, including peptides and BCS class III and IV small molecules, and preventing their breakdown in the digestive tract. Leuprolide is a gonadotropin-releasing hormone analogue that is used to treat endometriosis and uterine fibroids in women, prostate cancer in men, and central precocious puberty in boys and girls.

The research detailed the results from a 22-patient study examining the pharmacokinetic (PK) profile and dose-proportionality of oral leuprolide compared to historical data for highly effective injectable leuprolide products. Results from the study confirmed that the oral delivery of leuprolide produced levels expected to be within established therapeutic ranges with Ovarest delivering more drug than highly effective injectable leuprolide formulations. Further, leuprolide oral tablets delivered in total daily doses from 80 to 120 mg appeared to be safe, well tolerated, and roughly dose proportional.

“The data presented at ASRM 2022 demonstrate PK and safety results that, we believe, support further development of Ovarest as a differentiated alternative to current dosage forms of the GnRH agonist leuprolide given its potential to eliminate the need for potentially painful injections,” Shangold said. “GnRH agonists are known to be effective at addressing numerous disorders, however the need to inject such therapeutics can limit their acceptability and marketability. Our intent is to develop Ovarest for disease indications that are underserved by current therapeutic options.”

Details of the oral presentation are as follows:

Event: ASRM Scientific Congress & Expo
Title: Pharmacokinetic (PK) Study of Oral Leuprolide Delivery with Ovarest® Achieves Drug Levels Exceeding those of Approved Injectable Products
Author(s): Gary A. Shangold M.D., Arkady Rubin PhD, Thomas Daggs, John Vrettos PhD, Andrejs Rasums, Angelo Consalvo, Nicola Skeet, Sreeja Variam, Kalpana Ramakrishnan PhD, and Paul Shields PhD
Day / Time: October 26, 2022, at 11:05 AM, PT
Location: Anaheim Convention Center

About Enteris BioPharma

Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH) offering total integrated contract development and manufacturing (CDMO) services including innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®. The technologies have been the subject of numerous feasibility studies and active development programs, several of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option. For more information on Enteris BioPharma and its proprietary oral drug delivery technologies, please visit https://www.EnterisBioPharma.com.

For Enteris BioPharma:
Kalpana Ramakrishnan, Ph.D.,
Manager, Business Development

Enteris Media Relations:
Jason Rando
Tiberend Strategic Advisors, Inc.