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MORPHIC THERAPEUTIC Morphic Announces Corporate Highlights and Second Quarter 2021 Financial Results August 4 , 2021 MORF - 057 phase 1 safety , receptor occupancy , PK and mechanistic measures exceeded objectives ; phase 2 program expected to begin 1Q22 Presented positive preclinical data from avẞ8 program at AACR Annual Meeting demonstrating anti - tumor activity in checkpoint refractory cancer models Announced Appointment of Susannah Gray to Morphic Board of Directors WALTHAM , Mass . , Aug. 04 , 2021 ( GLOBE NEWSWIRE ) -- Morphic Therapeutic ( Nasdaq : MORF ) , a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases , today reported corporate highlights and financial results for the second quarter of 2021 . Recent Highlights and Outlook • Presented positive phase 1 data fully supporting MORF - 057 target product profile at the European Crohn's and Colitis Organisation ( ECCO ) Virtual Congress 2021 • MORF - 057 well tolerated at all doses ( 25 to 400 mg ) , no safety signals observed • Predictable and dose - dependent pharmacokinetics ( PK ) surpassing preclinical modeling o Pharmacodynamic ( PD ) results strongly supportive of MORF - 057 continued clinical development ■ Dose and time dependent a4ẞ7 receptor occupancy including receptor saturation in all subjects at 100 mg BID ■ Biomarker changes , including lymphocyte subset migration and CCR9 transcript levels , provide early proof of biology ■ Changes in lymphocyte subsets and CCR9 levels are consistent with published literature on intravenous integrin inhibitors in inflammatory bowel disease ( IBD ) , despite the brief 14 - day duration of exposure to MORF - 057 in the phase 1 trial • Phase 2a open - label trial design • 12 - week induction phase with rollover to 40 - week maintenance phase in patients with moderate to severe ulcerative colitis scheduled to commence first quarter 2022 • The primary endpoint is the change in Robarts Histopathological Index ( RHI ) at 12 weeks of treatment with MORF - 057 • Study will assess additional PK and PD measures including the key PD measure of a4ẞ7 receptor occupancy • 100 mg BID MORF - 057 dose enrolling up to 30-35 patients o All phase 2 readiness work , including chronic toxicology studies , scheduled for completion in third and fourth quarters of 2021 • Phase 2b randomized controlled trial design • Global , randomized , placebo - controlled trial enrolling approximately 280 patients with moderate to severe ulcerative colitis , staggered and in parallel to the phase 2a trial • The primary efficacy endpoint will be the proportion of subjects with Mayo Clinic Score Response at 12 weeks and patients will then be followed beyond the 52 - weeks of treatment duration • The trial will also measure multiple secondary endpoints including Mayo Clinic Score Remission at 12 weeks , RHI , Patient Reported Outcome scores and translational markers