Therapists Marcela Ot'alora and Bruce Poulter are trained to conduct MDMA-assisted psychotherapy. In this reenactment, they demonstrate how they help guide and watch over a patient who is revisiting traumatic memories while under the influence of MDMA. (Photo: Multidisciplinary Association for Psychedelic Studies)

MD­MA, now in Phase III, shows promise as a PTSD treat­ment

The first time Lori Tip­ton tried MD­MA, she was skep­ti­cal it would make a dif­fer­ence.

“I re­al­ly was, at the be­gin­ning, very ner­vous,” Tip­ton said.

MD­MA is the main in­gre­di­ent in the club drug known as ec­sta­sy or mol­ly. But Tip­ton wasn’t tak­ing pills sold on the street to get high. She was try­ing to treat her post-trau­mat­ic stress dis­or­der by par­tic­i­pat­ing in a clin­i­cal tri­al.

Af­ter tak­ing a dose of pure MD­MA, Tip­ton lay in a qui­et room with two spe­cial­ly trained psy­chother­a­pists. They sat next to her as she re­called some of her deep­est trau­mas, such as dis­cov­er­ing her moth­er’s body af­ter Tip­ton’s moth­er killed two peo­ple and then her­self in a mur­der-sui­cide.

“In the em­brace of MD­MA,” Tip­ton said, she could re­vis­it that mo­ment with­out the usu­al ter­ror and pan­ic. “I was able to find such em­pa­thy for my­self.”

Sci­en­tists are test­ing how phar­ma­ceu­ti­cal-grade MD­MA can be used in com­bi­na­tion with psy­chother­a­py to help pa­tients with a se­vere form of PTSD that has not re­spond­ed to oth­er treat­ments. Un­like street drugs, which may be adul­ter­at­ed and un­safe, re­searchers use a pure, pre­cise­ly dosed form of the drug.

MD­MA is not yet avail­able as a treat­ment for PTSD out­side of clin­i­cal tri­als. But pro­po­nents are aim­ing for ap­proval by the Food and Drug Ad­min­is­tra­tion, which grant­ed break­through ther­a­py sta­tus to MD­MA-as­sist­ed psy­chother­a­py in 2017.

Re­searchers are con­duct­ing Phase 3 clin­i­cal tri­als at more than a dozen sites. Clin­i­cians who treat PTSD are hope­ful the next round of tri­als will show that MD­MA treat­ment is an ef­fec­tive op­tion to re­lieve pa­tient suf­fer­ing.

“The prob­lem is we haven’t had a new drug to treat PTSD in over 17 years,” said Dr. Sue Sis­ley, a physi­cian and pres­i­dent of the Scotts­dale Re­search In­sti­tute, based in Ari­zona. “There are cer­tain ill­ness­es that are just in­tractable and not re­spon­sive to tra­di­tion­al ther­a­py, and we need to start think­ing more broad­ly.”

But MD­MA is a Sched­ule I con­trolled sub­stance, which means it cur­rent­ly has no ac­cept­ed med­ical use and has a “high po­ten­tial for abuse” (some­thing that MD­MA’s ther­a­peu­tic pro­po­nents dis­pute). Be­cause of that des­ig­na­tion, the cur­rent re­search tri­als are pri­vate­ly fund­ed by the Mul­ti­dis­ci­pli­nary As­so­ci­a­tion for Psy­che­del­ic Stud­ies, or MAPS.

‘Any­where I Would Feel Un­safe’

Tip­ton strug­gled for years with PTSD be­fore she was treat­ed with MD­MA. She said life with PTSD was like “see­ing the world through dirty gog­gles.”

“Any­where I would feel un­safe,” the 40-year-old from New Or­leans said. “I would feel like I had to al­ways be vig­i­lant be­cause if I didn’t, some­thing bad was go­ing to hap­pen.”

Tip­ton de­scribed her 20s as a cat­a­log of tragedy and trau­ma. It be­gan when her broth­er fa­tal­ly over­dosed in her home. Af­ter his death, she be­gan car­ing for her moth­er, who strug­gled with men­tal ill­ness. In 2005, Tip­ton’s moth­er killed two peo­ple and then her­self. Tip­ton dis­cov­ered their bod­ies.

“I com­plete­ly just dis­as­so­ci­at­ed. I couldn’t be­lieve what I was see­ing,” Tip­ton said.

The trau­mas con­tin­ued to pile up. The place she lived was de­stroyed when Hur­ri­cane Ka­t­ri­na hit New Or­leans, and the fol­low­ing year, she was raped.

As the years went by, Tip­ton had pan­ic at­tacks and ter­ri­ble anx­i­ety. She tried every­thing to treat her symp­toms: talk ther­a­py, an­ti­de­pres­sants, hyp­nother­a­py, med­i­ta­tion and yo­ga. Noth­ing worked. She went through life ex­haust­ed and ap­a­thet­ic, con­stant­ly trig­gered and strug­gling to be in­ti­mate with peo­ple close to her.

Then Tip­ton en­rolled in the Phase 2 clin­i­cal tri­als for MD­MA-as­sist­ed psy­chother­a­py.

MD­MA And Ther­a­py To­geth­er

MD­MA was first syn­the­sized in 1912, and its ther­a­peu­tic ben­e­fits were stud­ied in the 1970s. But those ef­forts stalled when the U.S. fed­er­al gov­ern­ment — in light of the grow­ing pop­u­lar­i­ty of ec­sta­sy as a recre­ation­al drug — des­ig­nat­ed it a Sched­ule I drug in 1985.

In re­cent years, re­search has re­sumed, fund­ed by pri­vate spon­sors such as MAPS.

The treat­ment pro­to­col in the cur­rent tri­al calls for a 12-week course of psy­chother­a­py with spe­cial­ly trained ther­a­pists. Dur­ing that time, there are two or three day­long ses­sions, which be­gin with the pa­tient tak­ing a cal­i­brat­ed dose of MD­MA in pill form.

A team of two ther­a­pists, gen­er­al­ly one man and one woman, then guide the pa­tient through the eight-hour MD­MA “ses­sion.” Lat­er, there’s fol­low-up talk ther­a­py, with­out the drug, to help the pa­tient process feel­ings, thoughts or im­pres­sions that came up while un­der the in­flu­ence of the drug.

“MD­MA al­lows you to con­tact feel­ings and sen­sa­tions in a much more di­rect way,” said Saj Razvi, a Col­orado-based psy­chother­a­pist who was a clin­i­cal in­ves­ti­ga­tor in the Phase 2 tri­als.

How MD­MA works in the brain is not com­plete­ly un­der­stood. The psy­choac­tive drug boosts chem­i­cals like sero­tonin and oxy­tocin. It al­so tamps down ac­tiv­i­ty in the amyg­dala, a part of the brain that process­es fear. This may lead to a state char­ac­ter­ized by height­ened feel­ings of safe­ty and so­cial con­nec­tion.

“Trau­ma hap­pens in iso­la­tion,” Razvi said. “One of the things that MD­MA does is, re­al­ly, lets you know that you are not alone.”

PTSD In Re­mis­sion

Af­ter the Phase 2 tri­als of MD­MA-as­sist­ed treat­ments con­clud­ed in 2017, re­searchers found that 54% of the 72 pa­tients who took MD­MA had im­proved to the point that they no longer fit the di­ag­no­sis for PTSD (com­pared with 23% in the con­trol group).

And the ben­e­fi­cial ef­fects of the treat­ment ap­peared to in­crease over time. A year lat­er, the num­ber who no longer had PTSD had risen to 68%.

“That was as­ton­ish­ing,” Sis­ley said. “Even with the best phar­ma­ceu­ti­cal reg­i­men, you rarely ever see pa­tients go in­to re­mis­sion.”

She said she hopes to of­fer her pa­tients MD­MA-as­sist­ed psy­chother­a­py as soon as pos­si­ble, maybe be­fore the drug re­ceives full FDA ap­proval.

Brad Burge, a spokesman for MAPS, said that, be­yond spon­sor­ing the MD­MA tri­al, the or­ga­ni­za­tion is work­ing to get the FDA to in­clude the drug in its ex­pand­ed ac­cess pro­gram, which can al­low in­di­vid­ual pa­tients to be ap­proved to use drugs that are still be­ing stud­ied.

Burge said the goal is to make MD­MA-as­sist­ed psy­chother­a­py avail­able as a pre­scrip­tion treat­ment in a spe­cial­ty clin­ic to any­one with PTSD.

And MAPS is work­ing to per­suade pub­lic and pri­vate in­sur­ance plans to cov­er the treat­ment, Burge said. He es­ti­mates that for pa­tients pay­ing en­tire­ly out-of-pock­et, a 12-week course of treat­ment would cost be­tween $5,000 and $10,000.

Most of the cost is for the guid­ed ther­a­py, not the ac­tu­al drug.

Trans­for­ma­tive Treat­ment

Tip­ton de­scribes her treat­ment with MD­MA as trans­for­ma­tive.

She was able to let go of the trou­bling feel­ings sur­round­ing her moth­er’s death. And, she un­earthed oth­er mem­o­ries, too, feel­ings of joy that had been sealed away.

By her last MD­MA ses­sion, Tip­ton was even able to talk about her sex­u­al as­sault.

A year lat­er, she was re­assessed and no longer qual­i­fied as hav­ing PTSD. Tip­ton said she be­lieves the treat­ment saved her life.

“Every­thing is at my fin­ger­tips for me in a way that it nev­er was be­fore,” she said. “I want that for every­body.”

This sto­ry is part of a part­ner­ship that in­cludes KJZZ, NPR and Kaiser Health News.

Kaiser Health News (KHN) is a na­tion­al health pol­i­cy news ser­vice. It is an ed­i­to­ri­al­ly in­de­pen­dent pro­gram of the Hen­ry J. Kaiser Fam­i­ly Foun­da­tion which is not af­fil­i­at­ed with Kaiser Per­ma­nente.

Click here to see the orig­i­nal sto­ry

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,400+ biopharma pros reading Endpoints daily — and it's free.

Vu Truong, Aridis Pharmaceuticals CEO (Aridis/Nasdaq)

Aridis' mon­o­clon­al an­ti­body fails PhI­II, but plans for sec­ond tri­al any­way

Aridis Pharmaceuticals’ monoclonal antibody missed the bar in a Phase III test in ventilator-associated pneumonia caused by the gram-positive bacteria S. aureus, the company announced Wednesday. 

But Aridis is planning for a second Phase III study anyway once it discusses the findings with the FDA and the European Medicines Agency. Execs blamed recruitment challenges stemming from Covid-19 and Russia’s invasion of Ukraine for the miss, cutting their enrollment target in half.

Al Gianchetti, XyloCor CEO

Xy­lo­Cor wraps up PhII for heart dis­ease gene ther­a­py, plans for piv­otal tri­al

XyloCor Therapeutics says patients with heart disease who got its gene therapy could exercise for longer and had fewer chest pain attacks. The biotech announced it completed a Phase I/II trial of the gene therapy Thursday morning, and plans to move forward with a pivotal trial.

In the Phase II portion of the trial, 28 patients with angina (or chest pain) caused by coronary artery disease and who had no other treatment options were enrolled and were given the highest tested dose from the first part of the trial. Patients were followed for six months.