Additional data from a phase II trial of S1P modulator icanbelimod (CBP-307) reinforced earlier positive results in ulcerative colitis (UC), potentially putting Connect Biopharma Holdings Ltd. in a better negotiating position as it seeks a partner to take the program forward, while in-house activities remain focused on an early 2024 regulatory filing for atopic dermatitis candidate CBP-201.
Additional data from a phase II trial of S1P modulator icanbelimod (CBP-307) reinforced earlier positive results in ulcerative colitis (UC), potentially putting Connect Biopharma Holdings Ltd. in a better negotiating position as it seeks a partner to take the program forward, while in-house activities remain focused on an early 2024 regulatory filing for atopic dermatitis candidate CBP-201.
Buoyed by the progress it has made with its lead integrin therapy for moderate to severe ulcerative colitis, MORF-057, which significantly reduced disease activity in a phase IIa trial, Morphic Therapeutic Inc. is raising $240 million in a public offering to further advance the candidate through the clinic.
The long-anticipated top-line phase IIa study results for Morphic Therapeutic Inc.’s oral alpha 4 beta 7 integrin inhibitor, MORF-057, have surpassed even the company’s own expectations, with a significant decline in disease activity seen in moderate to severe ulcerative colitis (UC) patients combined with a safety profile consistent with phase I findings.
Manufacturing deficiencies stand in the way of two BLAs as complete response letters (CRLs) were issued to Eli Lilly and Co. and to Alvotech Holdings SA. The U.S. FDA issued the CRL to Lilly regarding the BLA for mirikizumab, a humanized IgG4 monoclonal antibody to treat ulcerative colitis, specifically citing manufacturing concerns. There’s a similar problem with Alvotech’s biosimilar candidate for Abbvie Inc.’s Humira (adalimumab). The FDA issued a CRL for AVT-02’s BLA, citing problems needing resolution at its Reykjavik, Iceland, manufacturing facility before it could approve the application.
Triastek Inc., a digital pharmaceutical solutions company, is taking a unique approach by using 3D printing technology to develop a pipeline that spans rheumatoid arthritis (RA), clotting disorders, ulcerative colitis and pulmonary hypertension. Its technology was recently validated through a partnership with Boehringer Ingelheim GmbH. The company’s 3D printing products include T-19, T-20 and T-21, which have all received IND approval from the FDA.
