Albireo Pharma’s PFIC Therapy; Lupin’s Trichomoniasis Oral Drug; Moderna’s Weapon Against COVID; Gilead & Novo Nordisk’s Cocktail Therapy for NASH

Albireo Pharma Hopeful to Commercialize its PFIC Treatment by the End of the Year

Albireo Pharma, spun out of AstraZeneca, has long been working on developing potential and efficient treatment drugs for the patients suffering from progressive familial intrahepatic cholestasis (PFIC), a rare disorder that leads to insidious liver failure. Now, it seems the dream of the company might come true. 

Positive results of Phase III trial PEDFIC 1 presented at the American Association for the Study of Liver Diseases’ annual meeting demonstrated some promising outcomes. The data showed that the treatment with odevixibat,  a potent, non-systemic ileal bile acid transport inhibitor (IBATi), statistically reduced the levels of serum bile acids (sBAs) and improved pruritus in pediatric PFIC patients. The drug met all its primary endpoints and as add-ons yielded consistent, durable, and continued promising results. 

In its endeavor to launch odevixibat in the PFIC market that currently holds no approved therapy for this rare and devastating disease, the company is looking forward to filing a New Drug Application with the U.S. FDA and the EMA in the early part of 2021. The company hopes to receive a priority review, thereby potential approval and launch by the end of 2020.

FDA Accepts Lupin’s Supplemental New Drug Application Filed for Trichomoniasis Treatment, Solosec 

A U.S. based wholly-owned subsidiary of Lupin Limited, Lupin Pharmaceuticals shared good news regarding the acceptance of supplemental drug application for its drug solosec. The US FDA has issued the drug a Prescription Drug User Fee Act (PDUFA) target date of June 30, 2021. 

The company has been investigating Solosec (secnidazole) for the treatment of trichomoniasis in adults and adolescents. If approved, Solosec will be the first and only single-dose oral prescription treatment option available to treat patients suffering from Trichomoniasis vaginosis (BV), the most common non-viral, curable sexually transmitted infection (STI) in the U.S.

The present trichomoniasis market is dominated by antibiotics such as Metronidazole (Flagyl) or tinidazole (Tindamax). However, antimicrobial resistance is an emerging point of concern that hinders in altering the course of the disease. Thus, the trichomoniasis therapeutic market is in dire need of technological advancements stopped with a better and improved understanding of the disease. As per the analysis by DelveInsight, the trichomoniasis pipeline is scarce, and Lupin appears to be the only hope that has the potential to change the market dynamics with its oral treatment in the coming next decade. 

Another Hope Lights Up as Moderna Declares its COVID-19 Vaccine  is Over 94% Effective

After Pfizer, Moderna today made a huge splash after announcing the interim results of the Phase III clinical trial (COVE) of its COVID-19 vaccine mRNA-1273. Shares of the company soared after the good news was shared. 

The company announced that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. The trial enrolled over 30,000 patients in the U.S. and was being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). The results, however, are based on the first 95 to develop Covid-19 symptoms. Only five of these 95 were injected with the vaccine, the rest being given a dummy treatment. The vaccine was able to protect 94.5% of people.

The results came hot on the heels of Pfizer’s announcement of its COVID-19 vaccine with efficiency over 90 percent, adding the second player to the list of those boosting the confidence to end the corona crises as early as possible. The company plans to move forward with emergency approval and prepare to provide approximately 20 million doses in the US by the end of 2020. 

Gilead and Novo Nordisk presented the results of Phase II proof-of-concept clinical trial testing semaglutide in combinations with Gilead’s FXR agonist cilofexor and/or Gilead’s ACC inhibitor firsocostat in non-alcoholic steatohepatitis (NASH). 

Novo Nordisk’s Semaglutide is a GLP-1 analog that along with stimulating the secretion of insulin also improves glucose metabolism in the liver and increases fatty acid oxidation. The trial evaluated the combinations in five arms, and all combinations were well-tolerated. 

The positive results bolster Gilead’s confidence in fortifying the NASH pipeline, which has earned the tag of a hard nut to crack. The company acquired frisocostat from Nimbus Therapeutics and cilofexor from Phenex Pharmaceuticals. Another drug, that the company homes, is selonsertib, which failed to yield the desired results. As several other pharma players including Intercept, Genfit, Madrigal, and NGM Bio/Merck are emerging as potential rivals in the NASH market, it seems Gilead has not lost touch as it continues to crack the NASH puzzle.