As the coronavirus pandemic rages, drug development is becoming harder than ever, if arguably even more important. What is the extent of the issue, and how can companies protect their pipelines?
The spread of coronavirus disease, or Covid-19, is putting entire countries under lockdown in Europe. Not only is the human cost of the disease staggering, but the pandemic is also damaging for businesses across the board. This is due to a number of factors, including restricted travel, building closures, and quarantines.
According to Pierluigi Paracchi, CEO of the Italian biotech Genenta Science, biotechs in Europe are also feeling the strain.
“All biotech companies are suffering a critical delay in preclinical activities,” he told me. “Labs are working at 20% of their capacity, and almost no new experiments start these days.”
Clinical-stage companies are also taking a big hit from the pandemic. Earlier this week, for example, the French company Sensorion’s Euronext Paris stock price tumbled by 30% when coronavirus set back a phase II trial of its hearing loss drug by around six months. Today, the Swiss biotech GeNeuro also postponed a phase II trial in multiple sclerosis for the same reason.
One reason for the delayed clinical trials is a refocusing of healthcare systems on the pandemic — as in the case of Sensorion — with fewer clinicians and hospital beds available for ‘non-essential’ studies. Additional factors include lower patient enrolment, staff shortages, regulators diverting resources, and deviations from the planned protocol.
“All the EU countries are in the same situation,” Paracchi said. “My news from Spain, France, and Germany is the same.”
Many clinical trials are still given priority, especially when treating patients with aggressive cancer such as glioblastoma. However, here another problem arises, as many of these patients could be highly vulnerable to infection.
“The ones that are probably in the most danger are the ones where the immune system is knocked out because of stem cell transplants or big tumors,” said Andreas Schmidt, CEO of the Singaporean single-cell sequencing company Proteona. “And that’s basically true for blood cancer.”
Accordingly, clinical trials often need extra safety steps when recruiting blood cancer patients as their doctors are often treating Covid-19 patients at the same time. Even if there was a Covid-19 vaccine in the market right now, Schmidt explained, the immune system of these patients would be too weakened to benefit.
So what can companies hit by the virus do to minimize the impact of coronavirus on their pipelines? The best protection, a vaccine, is likely still months away. In the meantime, for general preclinical activities, maximizing remote working is one method, though this will also rely heavily on a reliable internet connection. According to Schmidt, companies that have multiple centers around the world could also better cope with shutdowns.
“I can really see the advantage of having multiple centers of operation even as a startup right now,” he said. “No matter what happens, we will have an office.”
In terms of clinical development, new guidance has been released from regulators such as the FDA and the UK’s Medicines and Healthcare products Regulatory Agency. For example, adjustments to clinical trial protocols won’t need to be reported if they are to protect against Covid-19. Further advice includes finding ways to monitor patients and communicate online instead of via in-person checkups, and delivering certain medications to patients rather than on-site. However, this shouldn’t cause extra workloads for the centers, and should also keep patient data secure.
To minimize the coronavirus risk for blood cancer patients, Proteona and partners around the world are developing a way to boost Covid-19 protection. They aim to analyze the blood of recovering Covid-19 patients to see what antibodies can stop the virus. They then plan to synthesize the antibodies and inject them as a passive immunity booster for blood cancer patients, though Schmidt couldn’t comment on when this would be available.
“We can do all that probably faster than most,” he told me. “We will be able to continue doing it no matter what the spread is in Germany right now. We have a completely independent, sealed off facility in Singapore.”
While this advice can help the operational side of biotechs, the economic impact of Covid-19 on the life sciences industry can’t be ignored. Companies with delayed pipelines will have to find ways of sustaining themselves for a longer period of time.
“The IPO window is almost closed now,” Paracchi noted. “It’s difficult to raise money for startups. I saw data for China, and the numbers of the VC investment in Q1 are very very poor.”
Another aspect of financing challenges is that small startups at the preclinical stage are also going to suffer more than big biotech and pharma companies, which usually have more funding and committed investors.
“What typically happens in such a situation is that the VCs protect their existing portfolio and they will make sure to give more money to companies that they have already invested in,” Schmidt elaborated.
“They will be more careful about investing in new companies. All these companies that are at the brink of investment will have an extremely hard time fundraising.”
According to Panacchi, one way to decrease the financial strain for biotech companies in the coronavirus pandemic could be so-called ‘helicopter money’ — a measure where central authorities directly pay consumers a financial stimulus to jump-start the economy — though this is still a largely theoretical concept.
Another way for companies to reduce financial and operational slowdowns is to “be part of the solution” as Schmidt explained. Many companies are developing tools to fight Covid-19, and funds are opening up to support this effort, including from the EU and charities such as the Bill and Melinda Gates Foundation.
One notable example of companies switching priorities is the UK biotech Synairgen, which — after discussions with governmental bodies around the world — paused its almost-complete phase II trial of a lung drug in chronic obstructive pulmonary disorder to launch a phase II trial of the same drug for the treatment of Covid-19 instead.
As time goes on, knowledge about the pandemic will increase, and allow governments and companies to better plan for disruptions. That said, until there are vaccines and effective treatments available, it’s going to be a rocky path for most of the biotech industry.
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