Cash runway is expected to be extended to at least 2025 as a result of the revised timeline for the global Phase 3 program for CBP-201 in atopic dermatitis (AD). A longer cash runway will allow us to continuously evaluate potential partnership opportunities to advance the global AD Phase 3 program.
China pivotal AD trial progressing well with completion of 36-week Stage 2 expected in H2 2023
SAN DIEGO & TAICANG, SUZHOU, CHINA, December 30, 2022 (GLOBE NEWSWIRE) — Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company) is entering a global clinical stage to develop a T cell-driven therapy is a biopharmaceutical company. Today, we provided a business update on its operations and clinical trial development programs to treat inflammatory diseases.
Co-Founder Dr. Zheng Wei said: CEO of Connect Biopharma. “However, in light of the current macroeconomic climate and difficult funding environment, it is imperative, after securing the necessary partnerships, to initiate the global Phase 3 program of CBP-201 in moderate to severe AD, We feel financially prudent.We will fully complete the program.The CBP-201 Global Phase 3 Program in AD was due to start by the end of the year, but the critical AD The trials were unaffected and are progressing well.”
“With this change in the timing of the Global Phase 3 program in AD, we expect cash runway to be extended to at least 2025, without considering additional funding, more than a year longer than our previous forecast. This is particularly important, said Steven Chan, CFO of Connect Biopharma, “This long runway will allow us to reach milestones in ongoing clinical trials and transition preclinical assets to the clinic. We look forward to continuing to evaluate partnership opportunities as we move forward.”
The company is actively seeking global and regional partners who may provide additional experience and infrastructure to support the next phase of clinical development of CBP-201. A differentiated treatment program with improved efficacy and dosing convenience. The partnership’s efforts extend beyond Alzheimer’s disease to include his CBP-201 in other disease indications with high unmet need, such as asthma, which is in Phase 2 and expected to report topline results in late 2023. We focus on the possibilities of
CBP-201 Pivotal AD Study in China
In October 2022, Connect Biopharma announced positive Stage 1 data on a primary analysis population of 255 patients and is currently conducting a 36-week Stage 2 period. The Company will hold a pre-new drug application (NDA) dialogue with the Center for Drug Evaluation (CDE) of the China National Drug Administration in the first quarter of 2023, and the Company’s CBP- 201 data package will be discussed. It could be approved as early as 2024 and in China as early as 2025.
A Phase 2 Study of CBP-307 in Moderate to Severe Ulcerative Colitis (UC)
The company also plans to complete the global Phase 2 maintenance phase of CBP-307 in the first half of 2023. In May 2022, the company reported efficacy data from his 12-week run-in phase of the trial showing that he will receive 0.2 mg of CBP-307 once daily. Significantly more patients compared to placebo to achieve clinical remission based on matched Mayo scores. The Company is actively licensing his CBP-307 for future trials in UC and Crohn’s disease, making it a competitive asset and a welcome addition to the gastroenterologist’s therapeutic arsenal Take advantage of the possibilities.
CBP-174 in pruritus associated with AD
The company previously reported results from a Phase 1 single escalating dose study of CBP-174 in pruritus associated with Alzheimer’s disease and continues to evaluate next steps toward clinical development.
Milestones planned for 2023
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CBP-201 Pivotal China Trial in AD: We plan to work with CDE in the first quarter of 2023. He expects to complete the 36-week Stage 2 in the second half of 2023
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CBP-201 in asthma: We expect to complete global Phase 2 enrollment in the first half of 2023 and report topline results in the second half of 2023.
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UC CBP-307: We have completed the Phase 2 maintenance phase and expect to report results in the first half of 2023.
About Connect BioPharma Holdings Limited
Connect Biopharma is a US- and China-based clinical-stage biopharmaceutical company dedicated to improving the lives of patients with inflammatory diseases through the development of therapeutics based on T-cell research. We have built a rich pipeline of proprietary small molecules and antibodies that use functional T cell assays to screen and discover potent product candidates against validated immune targets. The Company’s lead product candidate, CBP-201, is an investigational antibody designed to target interleukin-4 receptor alpha for the treatment of atopic dermatitis and asthma. His second advanced product candidate for the Company, CBP-307, is a modulator of the S1P1 T-cell receptor and is being developed for the treatment of ulcerative colitis. His third product candidate for the company, CBP-174, is a peripherally acting antagonist of histamine receptor 3 being developed for the treatment of pruritus associated with atopic dermatitis.
For more information, please visit https://www.connectbiopharm.com/.
Forward-Looking Statements
Connect Biopharma cautions that statements contained in this press release that are not statements of historical fact are forward-looking statements. “could”, “could”, “could”, “could”, “could”, “expect”, “plan”, “anticipate”, Words such as “believe,” “estimate,” “intend,” “predict,” “seek,” “consider,” “could,” “continue,” “plan,” or any of these Negative forms of terms or other equivalent terms are intended to identify forward-looking statements. These statements include information about how long our current cash position will support our business needs and capital expenditure requirements, our plans to advance the development of our product candidates, and our ability to license any of our product candidates. Includes expectations. To obtain partnership funding for development programs, the timing of reaching development or regulatory milestones, and the potential of such product candidates (including achieving profit or profile or product approval). The inclusion of forward-looking statements should not be construed as a representation that Connect Biopharma will achieve any of its plans. Actual results are subject to risks and uncertainties inherent in our business and other matters described in our filings with the U.S. Securities and Exchange Commission (SEC), including our annual report on Form 20. Risks may vary materially from what is described in this release. F filed with the SEC on March 31, 2022, and also filed other reports. Investors are cautioned not to place undue reliance on these forward-looking statements. It speaks only as of the date hereof and Connect BioPharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. More information about these and other risks is available on the SEC’s website at www.sec.gov and Connect Biopharma’s website at www.connectbiopharm.com under the heading “Investors”. Included in SEC filings. All forward-looking statements are fully qualified by this cautionary statement. This warning is made pursuant to the Safe Harbor Provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACT: INVESTOR CONTACT Ina McGuinness 805.427.1372 imcguinness@connectpharm.com MEDIA Deanne Eagle 917.837.5866 deanne@mcguinnessIR.com
