Ex-FDA officials ask SCOTUS to take up J&J talc case; Annovis shows data from PhII Parkinson's trial
Eight former FDA officials, including former FDA commissioner Andrew von Eschenbach and multiple deputy commissioners, submitted an amicus brief to the Supreme Court yesterday — asking for the Court to review the Mississippi Supreme Court decision that ruled against J&J earlier this year.
Mississippi’s complaint in 2014 accused the mega-company of violating consumer protection laws by not disclosing ovarian cancer risks to women posed by its baby powder containing talc.
J&J sought summary judgment in its appeal to the court, arguing the Mississippi Consumer Protection Act doesn’t apply to the labeling of products regulated by the federal Food and Drug Administration. The Mississippi Supreme Court disagreed, and affirmed a lower court’s previous ruling.
The former officials argue that notice-and-comment rulemaking, which the FDA officials say is rarely used, subverts and upends the FDA’s system and authority over labeling.
“By stripping the FDA’s labeling decisions of preemptive effect unless they first undergo notice-and-comment rulemaking, the decision leaves the agency with an impossible choice: sacrifice the flexibility it needs to oversee thousands of products in an ever-shifting market, or allow its scientifically sound warnings to be crowded out by conflicting state-imposed labels,” the officials wrote.
The ex-officials further reiterated that the FDA lacks time and resources to run every decision through notice-and-comment rulemaking.
“According to the Mississippi Supreme Court, that reality means FDA must share labeling authority with all 50 states, any one of which can require a label specifically rejected by FDA as scientifically unsound,” the officials wrote.
Ultimately they want the Supreme Court to “clarify the law of preemption and prevent the Mississippi Supreme Court’s decision from disrupting FDA’s vital functions,” the writers said.
Annovis Bio unveils Phase II efficacy data for Parkinson’s disease treatment
Pennsylvania biotech Annovis Bio released results from the second part of a Phase II clinical trial of Parkinson’s drug candidate ANVS401 in 54 patients, which found that once-daily ANVS401 was superior to placebo in improving motor function.
The first part of the study made headlines and caused share prices to soar upwards of 140% after patients’ cognitive improvement scores increased by 30% back in May for subjects with either Parkinson’s disease or Alzheimer’s disease.
The second part of the study expanded on the original 14 AD and 14 PD patients by recruiting an additional 40 PD patients, who were treated with either 0mg, 5mg, 10mg, 20mg, 40mg or 80mg of ANVS401 once daily. Safety and two psychometric assessments were conducted at day 0 and day 25, comparing ANVS401-dosed PD patients with those dosed with placebo.
When compared to the placebo group, statistically significant improvements in a WAIS psychometric coding test were observed in PD patients taking ANVS401 5mg, 20mg and 80mg once daily, highlighting increased motor dexterity, as well as speed and accuracy compared to placebo. PD patients treated with ANVS401 10mg and 20mg once daily showed statistically significant improvements in the UPDRS psychometric test compared to baseline.
These results provide guidance as to what dosage to use in upcoming Phase III studies in both AD and PD patients, according to a company statement.
“We are still analyzing certain biomarker data from the 54 PD patients and will share the results when they are available. We will be asking the FDA for a meeting to receive guidance on next steps in clinical development in light of the AD/PD Phase II clinical results,” said Annovis founder, president and CEO Maria Maccecchini in a statement.
IpiNovyx Bio closes $10 million seed financing round
With a focus on autoimmune and inflammatory diseases, IpiNovyx Bio closed a $10 million seed financing round today, the company announced in a statement.
The financing, led by Viva BioInnovator of Viva Biotech, also had participants such as Eli Lilly and the New York-based IpiNovyx founder Orange Grove Bio. Funds raised will go toward advancing so-called immunoproteasome inhibitors into human trials.
“Patients suffering from autoimmune and inflammatory diseases are faced with limited treatment options and most therapies that are available are non-selective and carry significant toxicity concerns. We are eager to continue our research in this area and work to advance these best-in-class immunoproteasome inhibitors into human clinical trials,” said Carl Nathan, a Cornell immunologist and one of the scientific founders at IpiNovyx.
“This seed funding will enable the company to rapidly progress through preclinical studies and into the clinic with the goal of delivering life changing therapies to patients suffering from autoimmune and inflammatory diseases,” said Marc Appel, co-founder and CEO of both IpiNovyx and Orange Grove Bio, in a statement.
Aditxt to acquire AiPharma, the rights holder of Covid-19 antiviral Avigan by end of November
Virginia biotech Aditxt said today that it entered a transaction agreement to reach a definitive agreement by the end of November to acquire AiPharma, which holds exclusive rights to Avigan and all formulations of antiviral favipiravir, used in different countries as a Covid-19 antiviral treatment.
The oral antiviral pill has either full marketing authorization or EUA in a number of markets as a treatment for Covid-19, including Mexico, India, Indonesia, Thailand and Malaysia, according to a company statement. Other countries buying the drug under compassionate use programs include the United Kingdom, United Arab Emirates, Greece, Hungary and Saudi Arabia.
“The successful completion of this acquisition would accelerate our commercialization plans in the infectious disease space,” said Aditxt co-founder and CEO Amro Albanna. “While initially targeting COVID-19, our combined clinical and commercial platform would potentially address unmet needs in other viral indications. We look forward to partnering with the team at AiPharma and its consortium members.”