The Garetosmab clinical trial was urgently halted due to the death of several patients

Recently, after leading to the death of several patients, Regenerative Meta announced the suspension of its rare osteopathic drug Garetosmab (REGN2477) LULINA-1 trial.
said it was reviewing the test data to better understand the risk/benefit status of the drug.
, regeneratives have informed the independent data monitoring committee and regulatory body corresponding to the trial of the status and decision to suspend the trial.
decision to suspend the trial due to a number of fatal adverse reactions in the open label extension test.
regenerative metapharmaceuticals said in a statement Friday that in an expanded trial of the open label, several patients who received the Garetosmab drug died, while no patients died in the placebo control in the trial.
so far, the company has not specified how many patients have died, and the company is investigating the deaths further to see if the deaths are directly related to Garetosmab.
in January this year, Garetosmab reported positive results for the treatment of Osteoporosis (FOP) Phase II LUMOINA-1 test.
trials mainly recruited 44 FOP patients aged 18 to 60 from North America and Europe.
In the main analysis after 28 weeks of treatment, garetosmab treatment reduced overall lesions activity (new and existing lesions) by 25 percent and the formation of new lesions by nearly 90 percent compared to placebo.
in terms of safety, patients in both treatment groups showed side effects, but 19 of the 24 placebo patients and 20 Garetosmab treatment groups completed the 28-week trial.
most patients had mild to moderate side effects, but two patients developed more severe abscesses.
, the Garetosmab treatment group had a 10 percent chance of acute adverse episodes and the placebo group had a staggering 42 percent.
FOP is an extremely rare genetic disorder that can lead to abnormal bone formation in patients, resulting in bone malformations, sexual incapaure and premature death.
another commonly known disease as "stone man disease", meaning that as the disease progresses, the patient becomes as insulable as a stone.
currently, there are no approved drugs on the market for FOP treatment.
Garetosmab is a monoclonal antibody that, with the help of the regenerative Veloclmmune technology, is expected to reduce the formation of allogeneic osteopathy by meso-activating the vegetarian A protein.
despite the suspension of the trial, Dr. George D. Yancopoulos, President and Chief Scientific Officer of Regeneration, remains confident in Garetosmab and says, "We believe that Garetosmab may offer significant new hope that could change the FOP's treatment process and look forward to working closely with the FDA and other regulators to facilitate the listing of Garetosmab."
is not the only company exploring FOP treatments.
August, Ipsos announced positive results for palovarotene's multi-center Phase III trial to treat FOP.
results showed that patients treated with palovarotene had an average of 62 percent reduction in neo-hetero-osteolysis per year.
107 subjects participated in the MAVE trial, and the adverse reactions of the drug were mild (32.2%), moderate (45.5%) and severe (22.2%).
source: 1.Regeneron Hits Pause on LUMINA-1 Trial Due to Concerns with Garetosmab 2.Regeneron slams the brakes on rare bone disease trial after patient deaths