VectivBio Raises $125 Million After Reporting Positive Results from Phase 2 Study of Apraglutide in SBS

Swiss rare disease focused biotech VectivBio raised $125 million in an underwritten public offering just minutes after reporting positive interim data from its ongoing phase 2 STARS Nutrition study evaluating the safety, pharmacokinetics, and efficacy of apraglutide in adult patients with short bowel syndrome with intestinal failure (SBS-IF) and colon-in-continuity (CIC).

The company priced 16.7 million ordinary shares at an offering price of $7.50 per share. Investors who have agreed to purchase shares in the offering include Cowen Healthcare Investments, Driehaus Capital Management, Eventide Asset Management, LLC, Forbion’s Growth Opportunities Fund, Frazier Life Sciences, Marshall Wace, OrbiMed, Surveyor Capital (a Citadel company), TCG X, Venrock Healthcare Capital Partners and Vivo Capital, among other specialist biotech investors.

VectivBio intends to use the net proceeds from the offering, together with its existing cash and cash equivalents to fund clinical development and pre-commercialization activities for lead product candidate apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, and for general corporate purposes.

SBS results from extensive intestinal resection due to chronic inflammatory bowel disease, acute events such as trauma, mesenteric infarction, bariatric surgery or congenital abnormalities. Symptoms of SBS include diarrhea, dehydration, malnutrition, and weight loss.

To survive, patients with severe forms of SBS require parenteral support (PS), the intravenous delivery of essential nutrients, calories, and fluids. For some patients, PS must be delivered for 10 to 15 hours per day, a significant burden that severely diminishes quality of life. In addition, people receiving chronic PS are exposed to increased rates of liver disease, and to an increased risk of infections due to the chronic presence of an infusion port positioned in a central vein. An estimated 35,000 people are thought to suffer from SBS in the United States and Europe, 15,000 who require lifelong PS and may thus be candidates for treatment with GLP-2 analogs.

Apraglutide is designed to increase the intestine’s ability to absorb fluids and nutrients, thereby minimizing the burden of parenteral support. Based on preclinical and clinical data to date, apraglutide has the potential to be a best-in-class treatment for SBS, designed for once-weekly dosing with the potential to address the needs of patients across the anatomical disease spectrum that characterizes SBS.

The STARS Nutrition study is a multicenter, open-label phase 2 metabolic balance study designed to evaluate the effects of once-weekly apraglutide on intestinal absorption and PS requirement in SBS-IF patients with CIC. is the first-ever study prospectively evaluating the clinical benefit of a GLP-2 agonist specifically in a CIC patient population. Patients with CIC anatomy represent more than half of the total SBS-IF patient population and are underserved by current treatment options. The study enrolled nine adult patients with a mean age of 46.8 years.

As of the cutoff date of October 7, 2022, five of nine patients had completed at least six months of treatment. Interim data showed that six-month treatment with weekly apraglutide resulted in an average 50 percent reduction in PS volume and a 47 percent reduction in parenteral energy content.   Eighty percent were clinical responders (defined as a reduction in volume of PS of at least 20 percent) and achieved at least one day off PS at 6 months. In the nine patients who reached at least three months of treatment, the average PS reduction was 31 percent after three months of treatment.

“The interim data from the open-label phase 2 STARS Nutrition study are very encouraging and demonstrate potentially clinically meaningful evidence that apraglutide can improve intestinal absorption and reduce PS dependency in CIC patients,” said Tim Vanuytsel, gastroenterologist, co-chair of the Leuven Intestinal Failure and Transplantation Center and lead investigator. “Patients with CIC anatomy represent the largest group of patients with SBS-IF. They have very complex and burdensome health needs and require routine PS, the intravenous delivery of essential nutrients and fluids, to survive.”

CIC patients represent over 55 percent of the SBS-IF population and have a preserved colon in continuity with the remnant small intestine. The presence of a functional colon allows CIC patients to absorb sufficient levels of water through oral ingestion and, therefore, require PS primarily for energy and nutrients. Historically, prospective clinical trials evaluating the efficacy of GLP-2 analogs in SBS-IF have not demonstrated a significant benefit in patients with CIC anatomy.

“These interim data further corroborate our belief in apraglutide as a potentially best-in-class GLP-2 analog for the treatment of SBS-IF addressing an area of high unmet need,” said Omar Khwaja, chief medical officer of VectivBio. “We expect to share top-line six-month data for all nine patients in the coming months.”

Author: Rare Daily Staff