54.3 F
San Diego
Thursday, Mar 28, 2024
-Advertisement-

Amplyx Takes Aim At Antifungals

Biotech investors seeking big returns don’t usually gravitate toward drugs that treat fungal infections. But increasingly, serial entrepreneurs (and their financial backers) see antifungals as a decent business opportunity. The latest infusion of cash against superbug strains goes to San Diego’s Amplyx Pharmaceuticals.

The company raised $40.5 million in a Series B round of financing from RiverVest Venture Partners, New Enterprise Associates, Biomed Ventures, and a crew of wealthy individuals in San Diego biotech.

The list includes Amylin Pharmaceuticals co-founder Ted Greene, former Amylin CEO Dan Bradbury, and former Receptos CEO Faheem Hasnain, who sold Receptos to Celgene Corp. for more than $7 billion earlier this year.

Along with the financing, Amplyx has brought on three biotech veterans to lead the company: Mike Grey, president and CEO; Ciara Kennedy, chief operating officer; and Susan Dube, vice president of business development and administration. All three previously worked at Lumena Pharmaceuticals, which had a successful exit last year when Shire Pharmaceuticals acquired the company for $260 million.

A Big Pharma Bargain

While he was CEO of Lumena, Grey uncovered a drug candidate that had been shelved at Pfizer Inc. that had untapped potential in treating rare liver diseases. Grey snatched LUM001 off the shelf for pennies and turned the drug candidate into Lumena’s top product.

“Big Pharma are very good companies, but they’re very bad at out-licensing,” Grey said in an interview last year with the San Diego Business Journal. “An area of potential that isn’t adequately tapped is identifying assets that pharma companies have invested in, but then put on the shelves. I think pharma companies shelve products because the market wasn’t large enough or they didn’t do the right study. I find that there are many examples where studies looking for a large market don’t select patients very well. But if you focus on a subset of the market and select the patients carefully, you could have had a very different outcome.”

It’s possible that Grey is considering that same strategy with Amplyx Pharmaceuticals’ lead product candidate, APX001, which was snatched off the shelves of another Big Pharma (Grey will not disclose which). The drug is a hopeful for life-threatening fungal infections such as candidiasis, invasive aspergillosis and rare molds. People with healthy immune systems can easily fend off these invaders, but they can be deadly for people with weakened immune systems, such as cancer patients undergoing chemotherapy.

Incentives Deliver

Over the past decade, the pharmaceutical industry moved out of anti-infective development en masse, citing high research costs, poor returns and too much red tape. It saw opportunities to make money elsewhere, with cancer and other chronic disease treatments driving big returns. Consequently, anti-infectives (including antibiotics and antifungals) dried up.

However, some R&D interest has been rekindled in recent years in reaction to incentives laid out in the GAIN Act, passed by Congress in 2012. That law gave developers of antibiotics and antifungals opportunities for quick regulatory reviews, and five extra years of market exclusivity if they can bring a drug to market.

In San Diego alone, several companies have recently cashed in on the space. Trius Therapeutics developed an antibiotic, tedizolid, approved last year to treat bacterial skin infections. By the time approval was granted, Trius had been purchased by Lexington, Mass-based Cubist. And last December, Cubist was purchased by drug giant Merck for $8.4 billion.

Another San Diego company developing an antifungal is Cidara Therapeutics, whose CEO, Jeff Stein, also headed Trius. In less than two years, the company raised $32 million in a Series A financing, $42 million in a Series B round and went public in April raising over $60 million. The overwhelming investor support may have been unusual before the GAIN Act, but those with deep pockets are beginning to see the benefit of expedited drug development (which can significantly shorten the path from the lab to sales-generating market approval).

Taking full advantage of fast-track approval granted by the FDA, Cidara is speeding through Phase 1 clinical trials.

The Path to Market

Amplyx will similarly take advantage of incentives and expedited programs, Grey said. The FDA offers these opportunities to companies that are developing qualified infectious disease products (ones that fight against resistant strains), and Grey believes APX001 will do just that.

The company expects to have data on rare molds from Phase 1 and 2 clinical trials by 2018, and perhaps an early filing with the FDA by 2019.

Amplyx is currently housed in Johnson & Johnson Innovation’s life science incubator, JLABS. Grey said the company will likely keep the research at JLABS, and open a small office in town for development.

-Advertisement-

Featured Articles

-Advertisement-
-Advertisement-

Related Articles

-Advertisement-
-Advertisement-
-Advertisement-