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Global Chronic Liver Diseases Therapeutics Market: Key Developments

In September 2021, Astellas is a multinational pharmaceutical company in Japan, announced that it has voluntarily paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating AT132 in patients with X-linked Myotubular Myopathy (XLMTM). This decision follows the reporting of a recent serious adverse event (SAE) in a study participant due to abnormal liver function tests (LFTs) observed in the weeks following dosing of the AT132 investigational gene therapy product at a lower dose (1.3x1014 vg/kg). Astellas voluntarily halted screening and dosing, reported the SAE to regulatory agencies, and is engaged in dialogue with regulators about this SAE.

On May 13, 2023, Astellas Pharma Inc., a multinational pharmaceutical company in Japan, announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VEOZAH is the first non-hormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

In October 2022, Bristol Myers Squibb, a biological and pharmaceutical research, producing the antipsychotic Abilify company, announced new results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with continuous Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. This analysis assessed patients from the pivotal POETYK PSO-1 trial transitioned into the LTE trial. At 112 weeks of Sotyktu treatment, modified non-responder imputation (mNRI) response rates were 82.4% for Psoriasis Area and Severity Index (PASI) 75, 55.2% for PASI 90 and 66.5% for static Physician's Global Assessment (sPGA) 0/1.

In June 2022, Gilead Sciences, Inc. is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines, announced that more than 80 abstracts will be presented at the International Liver Congress (ILC) 2022, placed from June 22-26, 2022. Key oral presentations will include Week 48 primary endpoint data from the Pivotal Phase 3 program of Hepcludex (bulevirtide) evaluating its efficacy and safety for the treatment of hepatitis delta virus (HDV) and the impact of the treatment on patient-reported outcomes.

On June 1, 2023, Myriad Genetics, Inc., a company of genetic testing and precision medicine, launched new studies and expansion of its Precise Oncology Solutions portfolio at the 2023 American Society of Clinical Oncology (ASCO).

On March 22, 2023, F. Hoffmann-La Roche Ltd (Roche), a biotechnology company that develops drugs and diagnostics to treat major diseases, announced that it has entered into a collaboration with Eli Lilly and Company, a pharmaceutical company headquartered in U.S. to support the development of Roche’s Elecsys Chronic Liver Diseases Therapeutics.

In November 2022, GSK plc, a multinational pharmaceutical and biotechnology company with global headquarters in London, announced the publication of positive end of study results from the B-Clear phase IIb trial evaluating the safety and efficacy of bepirovirsen for the treatment of chronic hepatitis B (CHB) in the New England Journal of Medicine. The results showed that treatment with bepirovirsen, an investigational antisense oligonucleotide treatment, resulted in sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA both in patients on concurrent nucleoside/nucleotide analogues (NA) and patients not-on-NA therapy.

In June 2022, GSK plc, a multinational pharmaceutical and biotechnology company with global headquarters in London, announced promising interim results from the B-Clear phase IIb trial showing that bepirovirsen, an investigational antisense oligonucleotide treatment for hepatitis B, reduced levels of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA after 24 weeks’ treatment in people with chronic hepatitis B (CHB).

In March 2022, Invitae, a medical genetics company, announced full access to its Personalized Cancer Monitoring (PCMTM) platform to help detect minimal or molecular residual disease (MRD) in patients with solid tumors. Invitae PCM uses a novel set of personalized assays based on a patient's tumor to detect circulating tumor DNA (ctDNA) in blood, offering the ability to perform risk stratification, response assessment to treatment and detection of cancer recurrence, based on recent studies.In November 2022, Arrowhead Pharmaceuticals Inc., develops medicines that treat intractable diseases by silencing the genes, entered a drug development deal with GlaxoSmithKline Plc (GSK.L), a multinational pharmaceutical and biotechnology company with global headquarters in London, under which the British drugmaker will develop and market Arrowhead's potential treatment for patients with fatty liver disease NASH.