Akero Therapeutics (AKRO) : drug shows it reverses scarring in liver disease patients

• The experimental drug efruxifermin showed it can help patients with a type of liver disease to reverse scarring of the organ without worsening the condition in a keenly awaited mid-stage trial.
• This drug is being studied in patients with severe scarring or cirrhosis due to a type of fatty liver disease known as metabolic dysfunction-associated steatohepatitis (MASH).

Ticker:  AKRO

 

 

 

 

 

 

 

 

Akero Therapeutics reports preliminary topline results showing statistically significant reversal of compensated cirrhosis due to MASH-by both completer and ITT analyses-at Week 96 in phase 2b symmetry study 

• Co released preliminary topline week 96 results from SYMMETRY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH). Among patients with baseline and week 96 biopsies, 39% of patients treated with 50mg EFX experienced reversal of cirrhosis with no worsening of MASH, compared to 15% for placebo. In the Intent to Treat (ITT) population, with all missing week 96 biopsies treated as failures, 29% of patients in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH, compared to approximately 12% in the placebo group.
• With more than a doubling of effect size from weeks 36 to 96 in the 50mg group (from 10% to 24%), the SYMMETRY study underscores the benefit of longer EFX treatment for patients with compensated cirrhosis (F4).
• In a subgroup of patients with baseline and week 96 biopsies who were not taking GLP-1 at baseline, 45% in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH compared to 17% for placebo, suggesting that the observed reversal of cirrhosis was not attributable to GLP-1 therapy.

==Akero's (AKRO) drug for fatty liver disease misses main trial goal

 

Ticker:  AKRO

Oct 10 (Reuters) - Akero Therapeutics said on Tuesday its drug to treat a type of fatty liver disease showed improvement in patients in a mid-stage trial, but the data showed that the results were not statistically significant. 

Akero Therapeutics reports encouraging 36-week analysis of 96-week phase 2b symmetry study, with a trend on fibrosis improvement and statistically significant results for nash resolution, markers of liver injury and fibrosis, insulin sensitization and lipoproteins 

• A trend was observed for the primary endpoint of fibrosis improvement at 36 weeks, with 22% and 24% of the 28mg and 50mg EFX-treated groups, respectively, experiencing at least a one-stage improvement in liver fibrosis and no worsening of NASH, compared with 14% for placebo. In addition, 4% of patients in each of the EFX-treated groups experienced a three- or two-stage fibrosis improvement without worsening of NASH -- from compensated cirrhosis (F4) to F1 or F2, compared with 0% for placebo.
• Statistically significant rates of NASH resolution in 63% and 60% of patients at week 36 were observed for the 28mg and 50mg EFX-treated groups, respectively, compared with 26% for placebo, representing the highest response rates reported to date for NASH resolution in this patient population. Statistically significant improvements were also observed for both EFX groups in non-invasive markers of liver injury and fibrosis, insulin sensitization and lipoproteins.

Akero Therapeutics to Present Results from Phase 2b SYMMETRY Study Investigating Efruxifermin in Patients with Compensated Cirrhosis Due to NASH

SOUTH SAN FRANCISCO, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, will hold an investor conference on Tuesday, October 10 at 8:00 a.m. ET to share topline week 36 results from its SYMMETRY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin (EFX) in patients with compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). The topline results will include histology and changes from baseline in non-invasive measures of fibrosis, glycemic control, and lipoproteins as well as safety and tolerability.

Unusual Options Activity Wed 9/20/23

Stocks seeing volatility buying (bullish call buying/bearish put buying):

Calls:

• TVTX Oct 15 calls are seeing interest with 140 contracts trading vs. open int of 790, pushing implied vol up around 38 points to ~247.84%. The Co is expected to report its next earnings in late October/early November
  
• DYN Dec 7.50 calls are seeing interest with 80 contracts trading vs. open int of 1660, pushing implied vol up around 11 points to ~149.04%

Puts:

• ACRS Dec 7.50 puts are active with 320 contracts trading vs. open int of 2100, pushing implied vol down around 78 points to ~397.77%. The Co announced results from Phase 1 Multiple Ascending Dose Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor on Monday
• AKRO Nov 45 puts are active with 230 contracts trading vs. open int of 3150, pushing implied vol down around 13 points to ~166.85%

Sentiment: The CBOE Put/Call ratio is currently: 0.92, VIX: (14.17, +0.06, +0.43%).
October 20 is options expiration -- the last day to trade October equity options.

Insider Trading : Fri 8/11/23

Notable purchases -- JANA adds to THS; notable sales -- CEO active in PRI

Buyers:

• ADV Chief Executive Officer bought 50,000 shares at $2.60 - $2.66 worth ~$133K.
• AKRO Director bought 25,000 shares at $41.8634 - $42.3525 worth ~$1.1 mln.
• AVDL Chief Executive Officer bought 10,000 shares at $12.86 - $13.50 worth ~$132K.
• EMBC Chief Executive Officer/President, SVP-CFO, and SVP-General Counsel/Head of Business Development bought a total of 14,325 shares at $21.54 - $21.81 worth ~$311K.
• EXFY 10% owner bought 609,159 shares at $4.07 - $5.98 worth ~$2.8 mln.
• LTH Chief Executive Officer/Founder and Chief Financial Officer bought 42,951 shares at $16.73 - $17.15 worth ~$725K.
• MODV 10% owner Coliseum Capital bought 435,893 shares at $34.13 - $37.00 worth ~$15.6 mln.
• ONEW Chief Executive Officer / 10% owner bought 10,000 shares at $26.29 - $26.50 worth ~$264K.
• ROG Directors (2) bought a total of 3,665 shares at $148.0598 - $150.04 worth ~$549K.
• THS 10% owner JANA Partners (Barry Rosenstein) discloses the purchase of 41,500 shares worth approx. $1.9 mln.
• VFC Director bought 40,000 shares at $19.055 - $19.10 worth ~$764K.

Sellers:

• BYD Vice President sold 11,431 shares at $67.35 - $67.45 worth ~$770K.
• CNXN SVP, CFO & Treasurer sold 7,500 shares at $51.21 - $54.41 worth ~$398K.
• EQC EVP, General Counsel & Secretary sold 50,000 shares at $19.23 - $19.30 worth ~$963K.
• LPG Director sold 65,000 shares at $28.27 - $29.00 worth ~$1.9 mln.
• PRI Chief Executive Officer sold 4,000 shares at ~$213.4672 worth ~$854K.
• RSG EVP, Chief Marketing Officer sold 2,712 shares at $148.6504 - $148.70 worth ~$403K.

Insider Trading : Wed 8/2/23

Notable purchases -- Several Directors add to SHYF; notable sales -- 10% owner active in CACC

Buyers:

• AKRO Director bought 55,000 shares at ~$42.69 - $43.27 worth ~$2.4 mln.
• BFH Director bought 2,400 shares at $41.69 - $41.88 worth ~$100K.
• CBSH Director bought 5,000 shares at ~$53.0007 worth ~$265K.
• CROX Director bought 1,435 shares at $104.53 worth ~$150K.
• SHYF Directors (4) bought a total of 21,845 shares at $14.49 - $14.53 worth ~$319K.
• TBBK Director bought 5,868 shares at $37.30 - $37.84 worth ~$221K.

Sellers:

• CACC 10% owner sold 21,244 shares at $544.35 - $556.60 worth ~$11.7 mln.
• RRC SVP-Principal Accounting Officer sold 50,000 shares at ~$31.089 worth ~$1.6 mln.