Biotech startup Peptilogics just got FDA clearance to test the efficacy of its signature product

A Pittsburgh biotech startup has high hopes of making the city a center of AI-driven drug development for novel peptide therapeutics.

South Side-based biotech startup Peptilogics announced this week that it had received FDA clearance to begin Phase 1b clinical trials for its signature product PLG0206, a peptide therapeutic aimed at treating periprosthetic joint infections, which is a serious complication that can occur following joint replacements.

The clearance will allow the company, which was founded in 2013, to start enrolling participants for the new phase of trials in the first quarter of this year, moving forward from its successful Phase 1a trials last year, which demonstrated a baseline of safety and tolerability in the treatment.

The basis for PLG0206 comes from molecule development work that Peptilogics founder and CEO Jonathan Steckbeck started as a biochemistry graduate student at the University of Pittsburgh School of Medicine.

Jonathan Steckbeck. (Courtesy photo)

“When a patient has a knee or hip replacement, a small subset of them will get a bacterial infection on the prosthetic,” Steckbeck explained as his motivation behind the development of PLG0206. “Until now, the only treatment has been relatively aggressive surgery. There is no therapy or therapeutic-based treatments.”

Phase 1b trials will be the first official chance Peptilogics has to prove not just the safety of PLG0206, but the efficacy of it in patients experiencing those periprosthetic joint infections.

This latest trial will be open label to participants, and will allow Peptilogics to experiment with some of the dosing of the treatment as well. If successful, the company will be one step closer to providing patients and physicians with a risk-reducing and cost-saving treatment that will be attractive to insurance companies, hospital systems, and other relevant parties in the medical field.

Steckbeck said that preclinical data the team collected from animal samples and prosthetics removed from patients with the infections make him confident that Peptilogics will achieve its efficacy milestones in this new set of trials.

“That [data] gives us a lot of indication and hope that this drug can be very effective in treating this condition,” he continued. “But, you know, we have to prove that in people.”

The announcement of a new clinical trial comes after a major growth year for Peptilogics in 2021. After starting the year with a total of only three employees, the company ended it with 28. That rapid hiring followed a significant Series B raise of $35.4 million at the end of 2020. To support its efforts this year, Steckbeck said that the startup will soon be looking to raise its next round of capital and hire for even more roles. (See current open roles here.)

Marc Lesnick. (Courtesy photo)

Peptilogics’ recent growth and success is yet another piece of evidence that Pittsburgh is becoming a hub for new life sciences activity, as the city finds ways of merging its longtime medical expertise with the technical innovation that’s abounded here over the last decade. While the foundation for PLG0206 comes from a traditional drug development process, Steckbeck said it helped inspire other potential opportunities for artificial intelligence-driven discovery of even more peptide therapeutics for host of other conditions and infections.

“This AI platform is really what’s going to make peptide development for new drugs possible where in the past it really wasn’t,” Peptilogics SVP of Regulatory Affairs and Quality Marc Lesnick said. “It was just way too hit or miss, it was never going to work. And that’s kind of that’s the kind of the difference that Peptilogics is trying to make.”

That merging of AI and life sciences is something industry leaders have pointed to as a potential overlap where Pittsburgh could thrive. Plus, on the tails of Cognition Therapeutics‘ $40 million IPO and Cernostics‘ acquisition by Castle Biosciences, Peptilogics will join an increase in local momentum for the industry. And beyond those big deals, this FDA clearance and the uptick in support for life sciences startups through programs like AlphaLab Health, signify that the industry is amassing both the big and small players it needs to form a comprehensive sector of the tech economy.