Oragenics Receives Approval for Phase 2 Study

Oragenics (NYSE:OGEN) announced Wednesday (October 17) that it has been approved in Belgium to enroll patients in a Phase 2 trial for AG013, a drug for the mouth disorder Oral Mucositis (OM).

Receiving this clearance and allowing the company to expand its trial globally gives it an advantage to finish the trial in 2019 along with financing from recent warrant exercises, generating proceeds of approximately US$9.5 million.

Following regulatory milestones such as enrollment targets, Oragenics expects to finish enrollment in mid-2019 and release topline data from the trial between the middle and second half of the same year. Around 30 patients are currently enrolled in the ongoing trial in the US with the company planning to enroll close to 200.

“With the Belgian approval, it’s now a matter of activating those clinical trial sites. We already have six that have been identified in Belgium,” Alan Joslyn, CEO of Oragenics, said in a phone interview with the Investing News Network (INN). He added the next step will be shipping the drugs and facilitating an initiating site visit, which will take place in the next few weeks.

Despite a slow start to the trial, the company intends to pick up the pace with additional clinical trial sites in Germany and the UK, following approvals from regulatory bodies in those respective countries.

As the company is the first to develop a pharmaceutical drug from a genetically modified bacteria, the US Food and Drug Administration (FDA) requested the company to conduct an interim safety review before moving forward with the trial. Oragenics successfully completed the review and presented results at the end of May 2018.

Following additional funding from a public offering backed by Ladenburg Thalmann for US$13.8 million in mid-July, Oragenics was able to move onto expanding its trial. The combination of the financing to back the trials, coupled with health authorities in Belgium such as The Federal Agency for Medicines and Health Products means the company is on track to meet its milestones.

OM is one of the most common toxicities of cancer therapy. Almost all patients are undergoing radiation therapy, according to a 2017 study on the management of OM. It affects the mouth with pain, swollen gums, dryness and other effects which can lead to the inability to eat. Patients often need to pause chemotherapy treatment to treat severe forms of OM, Joslyn said.

The current available treatments for OM are either only available to a narrow population or just helps with the pain, representing a high unmet need for patients.

“We’re targeting the most vulnerable population developing OM, and that is head and neck cancer population that receives both cisplatin (chemotherapy) and daily radiation therapy,” Joslyn explained. “This patient population has OM occurrences around 90 percent.”

Oragenics is among four companies developing drugs for OM for this population group, all with fast track designation. Joslyn said his company’s product is differentiated by using a live product. The formula is linked with the natural human Trefoil Factor 1, which is what naturally heals and regrows damaged skin in the mouth from the salivary glands.

The Trefoil factor is then linked with the bacteria and freeze-dried. At home, patients mix the formula with another solution to rehydrate it and use it, like mouthwash three times daily, Joslyn said. The product is meant to help patients maintain regrowth before the chemotherapy and damages the mouth and causes OM.

Oragenics has an exclusive worldwide license on this product compound which was designed by its partner, Intrexon Actobiotics NV, a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON).

This live biotherapeutic is Oragenics most advanced product in development. The other drug in its pipeline is lantibiotics, which is a class of antibiotics with novel mechanism in development for multi-drug resistance.

Investor takeaway

Earlier in the day on Wednesday, Oragenics’ share price had an increase to almost 13 percent, but evened out at close to 10 percent over the trading period to close at US$1.25.

As mentioned, investors interested in Oragenics have several milestones to look forward to. Joslyn said the earliest event to look forward to in the trial is responses from additional health authorities; upcoming news can be found on the company’s site.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.