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Roberto Bellini, president and CEO of Bellus Health Inc.Esther Gibbons/Courtesy of Bellus Health Inc.

The Bellini family’s two-decade quest to repeat the blockbuster success of their HIV/AIDS drug maker BioChem Pharma hit a key milestone Monday, as their Bellus Health Inc. reported successful efficacy results for its treatment for chronic coughing.

The drug developer’s shares rose by as much as 75 per cent after Bellus, chaired by former BioChem chief executive officer Francesco Bellini and led by his son Roberto, reported positive results from a trial involving 310 people. The results showed test subjects taking either 50-mg or 200-mg versions of the drug experienced a 53-per-cent reduction in cough levels, and 34 per cent lower than those who took a placebo.

Those results are better than efficacy findings from trials by Bellus’s three competitors, pharma giants Merck & Co. Inc. of the U.S., Germany’s Bayer AG and Shionogi & Co. Ltd. of Japan, which are also developing drugs to inhibit chronic coughing. The U.S. Food and Drug Administration (FDA) hasn’t approved a new therapy for coughing since dextromethorphan – a staple in cold medications – in 1958.

Bellus stock finished the day at US$8.30, up 48 per cent on the Nasdaq. After the close of market, Bellus announced it would raise US$175-million selling common shares. More than 100 million shares had traded hands, larger than the company’s total float. The Bellinis own or control a combined 6.4 million shares, roughly 8 per cent of the stock

“We are absolutely delighted with the positive results” which position Bellus’s drug candidate, BLU-5937, “as a potential best in class” drug for chronic coughing,” Roberto Bellini said on a conference call with analysts.

The trial follows a strong 12 months for Canada’s teeming biotechnology sector, starting with last December’s record initial public offering by Vancouver-based COVID-19 antibody developer AbCellera Biologics Inc. A month later, Victoria’s Aurinia Pharmaceuticals Inc. received FDA approval to launch its lupus treatment into market, and this fall, Pfizer bought cancer drug developer Trillium Therapeutics Inc. of Mississauga in a US$2.26-billion deal – the second biggest takeover in the domestic sector after Shire Pharmaceuticals Group PLC’s $5.9-billion purchase of BioChem in 2001.

For Laval, Que.-based Bellus, Monday’s results bring redemption. In July, 2020, the company released disappointing efficacy results showing its drug didn’t reach its goal to reduce coughing by more than 25 per cent in test subjects. The stock crashed 72 per cent.

“Disappointing trial results are a part of the development process. The most important thing is to learn from failure and to make adjustments thereof,” Roberto Bellini said in an e-mail to The Globe and Mail. “We were always highly confident in the potential for BLU-5937 to treat refractory chronic cough and we’re happy that today’s trial has delivered compelling data.”

That trial also showed the most severely afflicted patients experienced a meaningful reduction in coughing, which led Bellus to narrow in on that patient group when it recruited people for the most recent study. Test subjects in the latest study were predominantly North American or European women, white, aged 60 and slightly overweight on average and coughed typically more than once every two minutes.

Equally significant, the Bellus drug continued to show minimal side effects compared with its competitors, namely on taste. Rival drugs – including gefapixant from Merck, which awaits a decision from the FDA next March on whether it can take sell its drug – have impaired taste for many trial participants. The Bellus trial found less than 7 per cent of people taking the two effective doses experienced any alteration in taste, and none had any partial or complete taste loss.

“These are very positive results” Bloom Burton analyst David Martin said in an interview. Bellus’s drug is “the most effective and most tolerable” for treating chronic coughing. “The big question [in drug development] is will it work in humans. I think they answered that today, so the biggest risk is off the table and the drug looks good from a competitive sense.”

Mr. Martin hiked his stock price target to US$16 a share from US$7.50, joining other analysts who similarly increased targets.

Monday’s results come 19 years after Francesco Bellini bought into Bellus’s predecessor, Neurochem, and became CEO. At the time he was fresh off the success of selling BioChem – developer of a key ingredient in the cocktail that has dramatically improved the lives of HIV/AIDS patients. But Neurochem’s lead treatment Alzhemed, intended to slow the onset of Alzheimer’s disease, delivered inconclusive results in 2007. Dr. Bellini handed the reins to his son in 2010 and the company changed its name to Bellus, but its follow-up drug to combat a kidney ailment also failed in 2016 to meet its objective. The stock crashed and Bellus was left with no meaningful prospects, nine employees, $8-million in cash and a market capitalization of $15-million.

But despite two failed attempts and after spending more than $300-million in investor money, including $60-million of the family’s fortune, the Bellinis carried on. Roberto Bellini learned researchers at Montreal’s Neomed Institute had discovered a molecule that could stop a sensory receptor in the upper airway, known as P2X3, from messaging the brain to trigger a cough.

That had huge potential. Chronic cough – lasting eight weeks or more – affects 10 per cent of people globally, according to Bellus. Millions of people cough constantly for months, even years, for unknown reasons, creating physical complications such as headaches, vomiting and sleep deprivation, as well as social and psychological problems. Merck had bought a biotechnology company months before that was also targeting the P2X3 receptor, but its drug also turned off another receptor that led to a loss of taste, while Neomed’s drug affected mostly P2X3. In February, 2017, Bellus licensed global rights from Neomed to develop BLU-5937 and started the multiyear journey to develop the molecule into an approved treatment.

The company’s next step is to discuss the results with the FDA in the new year, followed by expanded human trials later in 2022 involving 1,500 patients. With the company still in possession of global rights for the drug, “I think all options are on the table,” including striking marketing partnerships, raising money or selling the company outright, Mr. Martin said.

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