SARcode $44mn for PhIII dry eye study
This article was originally published in Scrip
SARcode Bioscience, a Brisbane, California-based ophthalmic biopharmaceutical company, has landed a very significant $44 million B series from venture backers, giving the company the funds its needs to take its lead candidate, SAR 1118, into a Phase III trial for dry eye syndrome.
Sofinnova Ventures lead the round with participants including Rho Ventures and existing investors Alta Partners and Clarus Venture Partners. The action has picked up in funding, as SARcode's Series B follows on the heels of what last month was cited as the largest strictly venture-funded financing of the year so far – Tesaro, the oncology-focused biotech, with its $101 million series B (scripintelligence.com, 22 June 2011).
Quinton Oswald, CEO of SARcode, told Scrip that the firm has been operating as a virtual company, with just about 10 employees, and has spent the bulk of its funds on its clinical programmes. He cited how the goal of the firm is to remain on this level and outsource many functions. With the series B, he stated, "We are more than well funded". The firm was founded in 2006, and in December 2006 it had secured $29 million in financing from Alta and Clarus.
The data, presented in May at the Association for Research in Vision and Ophthalmology annual meeting, showed benefits were evident in just two weeks, with a statistically significant (p<0.05) increase="" in="" tear="" production="" and="" improvement="" in="" visual-related="" functions="" (ability="" to="" read,="" drive="" at="" night,="" use="" a="" computer,="" and="" watch="" television="" (scripintelligence.com,="" 4="" may="" 2011).="">
Positive data from the mid-stage trial were cited by Sofinnova general partner, Garheng Kong, as a driving force behind the funding.
SAR 1118 is a topical, nonsteroidal small-molecule integrin antagonist that inhibits T cell mediated inflammation, a key component of dry eye. Specifically, it acts as a small-molecule antagonist of the integrin lymphocyte function-associated antigen (LFA-1), for patients with dry eye.
Dry eye syndrome is estimated to affect around 20 million people in the US alone, and up to 50 million worldwide. Dry eye is a chronic disorder of the keratoconjunctival epithelium and tear film caused by various factors. It is accompanied by symptoms such as ocular discomfort, visual disturbances and tear film instability due to decreased quality or quantity of tears. SARcode aims to show that its compound can alleviate both the signs and symptoms of dry eye by targeting what is believed to be the inflammatory origin of the debilitating disease.
Tears have raised levels of cytokines in dry eye syndrome, Mr Oswald noted, and SARcode believes it is a consequence of inflammation. "If we can break that inflammatory cascade through a unique mechanism of action, we believe we can do something about dry eye."
The only approved dry eye drug in the US is Allergan's ophthalmic ciclosporin emulsion 0.05%, Restasis, which is presumed to suppress ocular inflammation. The effect on inflammation arises from its action as an intracellular immunomodulator. But, as described by Mr Oswald, the labelling indicates that it can take six months to demonstrate any improvement in tear production. "In contrast, in our Phase II trials we saw increased tear production in two weeks and symptom improvement within 12 weeks". According to the US prescribing information, Restasis also has up to a 17% rate of ocular burning upon installation into the eye.
So far, in clinical trials for SAR 1118, the investigators have not seen accumulation for longer than 30 minutes. The fact that it is excreted in the body very quickly bodes well for its safety, Mr Oswald said.
The Phase III study involving some 588 patients is expected to begin in September, as a two-arm placebo-controlled trial, in contrast to the four-arm trial of the Phase II trial, and will use a 5% preparation of SAR 1118.
For its development programme, SARcode sees the importance of evaluation that doesn't focus solely on certain patient complaints in a trial (eg, feeling of grittiness, stickiness or a foreign body sensation). "What we've focused on is the visual-related function. Is a patient able to use their computer more often, read more often, or drive a motor car at night? We consider those more objective criteria," Mr Oswald noted. "Also, as we go forward to market, those are more objective for a doctor to use in terms of seeing whether the drug works or not."
The FDA looks for statistical relevance in the relief of signs and symptoms for dry eye disease, and trials in the area can be challenging, Mr Oswald said. "You have to be very careful in selecting patients to meet FDA requirements," Mr Oswald said. He pointed out how some firms failed with a clinical trial programme because they had difficulty showing a difference from placebo, and a lot of them have allowed artificial tears into the treatment arm during Phase III testing.
Some firms have found the process arduous. Inspire Pharmaceuticals (partnered with Allergan), halted its development work following failed Phase III trials and US regulatory roadblocks for its diquafosal tetrasodium (which it called Prolacria), a PTY2 receptor agonist. However, Inspire is getting royalties on the sale of the product, as it was launched in Japan by partner Santen Pharmaceutical, as Diquas. Santen touts the product as improving dry eye symptoms by promoting secretion of mucin and water, thereby bringing the tear film closer to a normal state. Diquas is the first PTY2 receptor agonist in the world to be formulated as an ophthalmic solution.
As SARcode moves through its development programme, Mr Oswald described what options the company might have. "One of the benefits of putting together a strong syndicate of investors is that it keeps our options open. So we could sell the programme, partner it with a strong partner, or given that we are talking about a specialty market we could launch the product ourselves. All three options are on the table."
Mr Oswald, who was hired last year as CEO, brings much experience in ophthalmic marketing, as he was most recently vice-president and business unit head for Genentech's Tissue Growth and Repair Business, and during his tenure oversaw the commercial launch of Lucentis (ranibizumab). Prior to that, he had led the North American ophthalmology business for Novartis. SARcode's chief medical officer, Dr Charles Semba, is also from Genentech.
In addition to exploring the ophthalmic solution of SAR 1118 for dry eye, SARcode is investigating the product for diseases of the posterior segment of the eye (Phase 1b) and is developing a sustained release formulation of the product (preclinical) for intraocular delivery.