Connect Biopharma Announces Topline Week 12 Results from the CBP-307 Phase 2 Trial in Patients … | Your money
Primary endpoint of change from baseline in adapted Mayo score for CBP-3070.2 mg once daily, oral dose showed numerical improvement, but did not reach significance statistical as measured by reduction in lymphocyte count, and CBP-307 was observed to be generally well tolerated
SAN DIEGO, CA and TAICANG, China, May 03, 2022 (GLOBE NEWSWIRE) — Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to the improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced top results at 12 weeks from its Phase 2 trial for CBP-307 (CBP-307CN002 ), a once-daily, orally administered, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of ulcerative colitis (UC).
Administration of CBP-307 0.2 mg demonstrated a numerical reduction for the primary endpoint of least squares (LS) mean change from baseline in the Adapted Mayo Score at week 12 which did not did not reach statistical significance. A significantly higher proportion of patients who received a 0.2 mg dose of CBP-307 achieved clinical remission based on both full and adjusted Mayo scores, which was accepted by the FDA as an endpoint leading in clinical trials that supported previous approvals for UC treatments. Additionally, reductions in lymphocyte counts in individuals receiving 0.2 mg of CBP-307 confirmed the pharmacodynamic activity of CBP-307 in patients with active UC.
“Ulcerative colitis is a serious chronic disease with a continuing unmet need. The overall 12-week results of CBP-307 demonstrate the therapeutic potential to induce a significant treatment response, consistent with clinical data from other S1P modulators in UC patients,” said David T. Rubin, MD, professor of medicine and chief of the section of gastroenterology, hepatology and nutrition at the Medical University of Chicago.
The primary endpoint of mean LS change from baseline in Adapted Mayo Score (stool frequency, rectal bleeding, and endoscopy scores) at Week 12 for CBP-307 0.2 mg and placebo was -2.65 and -2.01, respectively (p=0.103). Secondary endpoints that were met for CBP-307 0.2 mg included a significantly higher proportion of patients achieving clinical remission compared to placebo, as measured by adapted Mayo scores (28.3% vs. 9.6%, difference = 18.7; p = 0.016) and full Mayo scores (18.9% vs 5.8%, difference = 13.1; p = 0.044), respectively. For patients receiving CBP-307 0.2 mg, significant improvements were also noted for change in Complete Mayo Score (adapted Mayo Score with Physician’s Global Assessment) from baseline to Week 12 (mean LS change from baseline for CBP-307 versus placebo: -3.67 vs -2.74, p=0.05) and in clinical response as measured by the full Mayo score (52.8% vs 30.8%, p = 0.023). Analysis of exploratory pharmacodynamic endpoints showed that patients receiving CBP-307 0.2 mg had a mean percent lymphocyte count reduction from baseline of 51.2% with a reduced mean absolute lymphocyte count to approximately 0.8 (109/L) at week 12.
In the CBP-307 0.2 mg and placebo groups, the occurrence of drug-related treatment-related adverse events (TEAEs) was 66.0% and 38.5%, respectively. Additionally, the CBP-307 0.2 mg and placebo groups were similar in the occurrence of grade 3 or higher TEAEs (7.5% vs. 7.7%, respectively) and serious TEAEs (3.8% vs. 5.8%, respectively). There were no cases of progressive multifocal leukoencephalopathy and no deaths. The overall safety results of this study showed that CBP-307 was generally well tolerated in patients with moderate to severe UC. Considering the safety results as well as the efficacy results of this study, the Company believes that CBP-307 warrants further clinical development in UC.
“These front-line induction phase data demonstrate the potential of CBP-307 to benefit patients with moderate to severe UC,” said Zheng Wei, Ph.D., co-founder and CEO of Connect. Biopharma. “Together with the recent positive results from our Phase 2 study of CBP-201 in atopic dermatitis, they support our approach to T cell-focused research in immunological pathways. a global Phase 3 clinical program and the ongoing pivotal trial in China for atopic dermatitis, we plan to explore strategic partnerships to advance CBP-307 into future trials.
A companion set of today’s CBP-307 data is available in the Events and Presentations section of Connect Biopharma’s Investor Relations site at https://investors.connectbiopharm.com/presentations-events /events.
About the CBP-307CN002 trial
CBP-307CN002 is an active Phase 2 study evaluating the efficacy and safety of CBP-307 as induction and maintenance therapy in adult patients with moderate to severe UC. The randomized, double-blind, placebo-controlled, multicenter study enrolled a total of 145 patients in two active dose arms (CBP-307 0.1 mg [n=39]; CBP-307 0.2mg [n=53]) and a placebo arm (n=53) from more than 60 sites in 4 countries.
About Ulcerative Colitis
Ulcerative colitis (UC) is an idiopathic inflammatory condition of the mucosal and submucosal colon that has increasing prevalence globally, thought to be due to societal changes. There are approximately 600,000 to 900,000 people in the United States living with ulcerative colitis. When insufficiently controlled, UC leads to progressive organ damage that manifests as functional impairment and anatomical changes such as dysplasia, which may eventually progress to cancer. Despite the availability of new treatments that have advanced the standard of care, a “therapeutic ceiling” means that treatment options remain limited and clinical remission is still not achieved in 70-80% of patients.
Discovered in-house using Connect Biopharma’s proprietary immune modulation technology, CBP-307 is an orally administered small molecule designed to modulate the sphingosine 1-phosphate receptor 1 (S1P1), which is a target validated for the treatment of several inflammatory diseases, including UC. CBP-307 was observed to be generally well tolerated and showed evidence of clinical activity in the induction period of a Phase 2 clinical trial in adults with moderate to severe UC, suggesting potential for differentiated risk-benefit profile compared to clinical trial data of current orally administered therapies. CBP-307 is also undergoing an ongoing maintenance phase and safety follow-up in the CU Phase 2 trial and two completed Phase 1 trials and two underway in healthy volunteers.
About Connect Biopharma Holdings Limited
Connect Biopharma is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with inflammatory diseases through the development of therapies derived from T cell-driven research. It is building a rich pipeline of small molecules and of in-house designed and 100% owned antibodies using functional cell assays with T cells to screen and discover potent product candidates against validated immune targets. Its lead product candidate, CBP-201, is an antibody designed to target the interleukin-4 receptor alpha (IL-4Rα) being developed for the treatment of atopic dermatitis (AD) and asthma. The Company’s second most advanced product candidate, CBP-307, is a modulator of a T-cell receptor known as S1P1 in development for the treatment of UC. Clinical development has begun for its third product candidate, CBP-174, a peripherally acting histamine 3 receptor antagonist, for the treatment of pruritus associated with AD.
With operations in the United States and China, Connect Biopharma is building a rich global pipeline of molecules and antibodies targeting multiple aspects of T cell biology. For more information, please visit www.connectbiopharm.com.
FORWARD-LOOKING STATEMENTS (UPDATED)
Connect Biopharma cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may”, “could”, “will”, “would”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “has ‘intend to’, ‘predict’, ‘seek’, ‘contemplate’, ‘look ahead’, ‘potential’, ‘continue’ or ‘project’ or the negative form of these or other comparable terms are intended to identify forward-looking statements. Such statements include the Company’s plans to advance the development of its product candidates, the potential of such product candidates, including to obtain any benefit or profile, and trends within the population. ulcerative colitis, and partnerships for the future development of CBP-307. The inclusion of forward-looking statements should not be taken as a representation by Connect Biopharma that any of its plans will be realized. Actual results may differ from those indicated in this press release due to the risks and uncertainties inherent in Connect’s business Biopharma and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F filed with the SEC on March 31, 2022 and his other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Connect Biopharma undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Connect Biopharma’s filings with the SEC which are available on the SEC’s website (www.sec.gov) and on Connect Biopharma’s website ( www.connectbiopharm.com) under the “Investors” section. All forward-looking statements are qualified in their entirety by this cautionary statement. This disclaimer is made pursuant to the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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