Akero Therapeutics

GSK Acquires Efimosfermin Alfa from Boston Pharmaceuticals in $2 Billion Deal for Liver Disease Treatment

10 days ago

• GSK has agreed to acquire efimosfermin alfa, a phase III-ready liver disease drug, from Boston Pharmaceuticals in a deal worth up to $2 billion. • The acquisition includes an upfront payment of $1.2 billion, with potential for additional success-based milestone payments totaling $800 million. • This strategic move strengthens GSK's pharmaceutical portfolio in the liver disease therapeutic area, addressing significant unmet medical needs.

GSK Acquires Efimosfermin for $1.2 Billion to Target Steatotic Liver Disease

10 days ago

• GSK has agreed to acquire efimosfermin alfa from Boston Pharmaceuticals for $1.2 billion upfront, with potential additional milestone payments of $800 million, strengthening its hepatology pipeline. • Efimosfermin, a phase III-ready FGF21 analog, has shown promising results in reversing liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH), with a convenient once-monthly dosing regimen. • Steatotic liver disease affects approximately 5% of the global population with limited treatment options, and interventions that reduce fibrosis could save the US healthcare system between $40-100 billion over the next two decades.

Madrigal's Resmetirom Shows Promise in NASH Treatment Where Others Have Failed

2 months ago

• Madrigal Pharmaceuticals' resmetirom demonstrated significant efficacy in the Phase 3 MAESTRO-NASH trial, achieving both primary endpoints of NASH resolution and liver fibrosis improvement. • The once-daily oral thyroid hormone receptor β-selective agonist showed NASH resolution in 26-30% of treated patients versus 10% on placebo, positioning it as a potential first-approved therapy for this growing health concern. • Resmetirom's success stands in stark contrast to Gilead's selonsertib, which failed its Phase 3 STELLAR-4 trial, highlighting the difficulty in developing effective NASH treatments despite the condition's multi-billion dollar market potential.

OliX and Eli Lilly Forge $630M Deal for Novel RNAi Therapy Targeting MASH and Obesity

3 months ago

• OliX Pharmaceuticals has secured a landmark $630 million licensing agreement with Eli Lilly for OLX75016, an RNAi-based therapeutic targeting MASH and obesity. • The deal grants Lilly global rights to develop and commercialize OLX75016, with OliX maintaining responsibility for Phase 1 trials before transferring development control to Lilly. • Preclinical studies showed promising results when OLX75016 was combined with semaglutide, demonstrating enhanced weight loss and reduced rebound weight gain in primates.

Akero's Efruxifermin Shows Promise in Reversing Cirrhosis Due to MASH in Phase 2b Trial

4 months ago

• Akero Therapeutics' Efruxifermin (EFX) demonstrated statistically significant cirrhosis reversal in patients with MASH in a Phase 2b trial. • In patients with baseline and week 96 biopsies, 39% treated with 50mg EFX showed cirrhosis reversal without worsening MASH, compared to 15% with placebo. • The SYMMETRY study underscores the benefit of longer EFX treatment, showing a doubling of effect size from weeks 36 to 96 in the 50mg group. • Akero is continuing to evaluate 50mg EFX in the Phase 3 SYNCHRONY Outcomes study for patients with compensated cirrhosis due to MASH.

Altimmune and MindMed Join Nasdaq Biotechnology Index, Anticipate Key Clinical Data in 2025

5 months ago

• Altimmune and MindMed were added to the Nasdaq Biotechnology Index (NBI) on December 23, 2024, signaling recognition of their progress and potential. • Altimmune anticipates topline data from the Phase 2b IMPACT trial of pemvidutide for MASH in the second quarter of 2025, a key catalyst for the company. • MindMed is advancing its Phase 3 study of MM120 ODT for generalized anxiety disorder, with initial results expected in the latter half of 2025. • Both companies view their inclusion in the NBI as a validation of their efforts to deliver innovative treatments and long-term value to shareholders.

BioAge Labs Halts Azelaprag Trial Due to Safety Concerns, Faces Investor Scrutiny

6 months ago

• BioAge Labs discontinued its Phase 2 STRIDES trial of azelaprag for obesity treatment after observing elevated liver enzymes in participants. • The trial's halt led to a significant drop in BioAge's stock price, prompting investor concern and a formal investigation by Hagens Berman. • BioAge is now facing a class-action lawsuit alleging misleading statements about azelaprag's safety profile prior to the company's IPO. • Despite the setback, BioAge plans to advance other programs, including NLRP3 inhibitors for central nervous system targets, and is working on new drugs targeting azelaprag’s original target.

Madrigal's Resmetirom Nears Full Approval for NASH Cirrhosis Treatment Following Phase 3 Enrollment Completion

8 months ago

• Madrigal Pharmaceuticals completed patient enrollment for its MAESTRO-NASH OUTCOMES trial, evaluating resmetirom for compensated NASH cirrhosis. • The Phase 3 trial involves 845 patients and aims to measure the progression to liver decompensation events over two to three years. • Positive outcomes from the trial could support full approval of Rezdiffra for noncirrhotic NASH and expand its indication to cirrhotic patients. • Resmetirom, a liver-directed THR-β agonist, has already received accelerated approval for NASH with moderate to advanced liver fibrosis.

FDA Approves Rezdiffra (Resmetirom) as First Treatment for NASH with Liver Fibrosis

a year ago

• The FDA has granted accelerated approval to Rezdiffra (resmetirom) for adults with noncirrhotic NASH and moderate to advanced liver fibrosis. • Rezdiffra, a THR-β agonist, is the first FDA-approved medication for NASH, also known as MASH, marking a significant milestone. • Approval was based on Phase 3 MAESTRO-NASH trial data, which demonstrated improved liver fibrosis and NASH resolution compared to placebo. • Madrigal plans to launch Rezdiffra in the U.S. in April, with a patient support program to aid access and affordability.